PRTM News

Thailand: Thai Drug Control Division (TDCD)

noreply@blogger.com (Unknown) — Sun, 05 Feb 2017 14:43:00 +0000

Thai Drug Control Division (TDCD)

Welcome to Thai Drug Control Division. To access the complete database Login Id and password are required.

Some documents in this web site need specific program to operate. For the best result, you need to download or update program below and install it on your computer.

Thai Drug Database is properly maintained, but navigation the website and links is little tedious.

1. Major Categories are as below but few might not be working

2. Procedure of Generic Drugs Registration

3. Marketing authorization of vaccines in Thailand

Marketing Authorisation OF VACCINE are separately maintained which provides you the following results:

Summary Product Characteristic (SPC)
Registered Vaccine
List by Trade Name
List by Importer
List by Manufacturer
List by Group of Vaccine
Search

Vaccines URL: http://drug.fda.moph.go.th/zone_search/ser003.asp
http://drug.fda.moph.go.th/zone_search/ser004.asp

4. Name list of Modern Medicinal GMP Conformance Manufacturers

5. Name list of Traditional Medicinal GMP Conformance Manufacturers

Searching the database Registration drug

Statistical data volume produced, imported drugs, statistics licensing / drug.

http://fdaolap.fda.moph.go.th/logistics/drgdrug/Dserch.asp

Drug Database provides the following details:

· Trade names (Thailand)
· Trade Name (English)
· Form of the drug
· Types of drugs
· Drug control laws
· Terms of Use
· Ingredients Unit
· A licensee
· Facility Name
· Location
· Registration
· No. For License per Invoice

Note: Searching Database is solely in Thai language, for English results use Google translator.

· ชื่อทางการค้า Trade name

· ชื่อสารสำคัญ Named substances

· ทะเบียนยา registration

· ชื่อผู้รับอนุญาต A licensee

· ชื่อผู้ผลิตต่างประเทศ Manufacturer foreign

· ชื่อผู้แทนจำหน่าย Name dealers

Drug Information for the public
According to the National Drug Policy and Strategic Development of the National Drug Strategy 2555-2559 has set promoting the health and unbiased drug information for the public and healthcare professionals that is accessible and easy. present

In order to comply with such policies. The Food and Drug Administration has undertaken the development of drug information for the public. The nomination committee / subcommittee conducted continuously since 2549 include the operating results. Issued guidelines for the preparation of the accompanying guidelines ASEAN No. 1 and preparation of data for the drug. To be useful in the rational use of medicines, public information and a program for hospitals promotes the rational use of drugs. To publish media to the Internet through the website of the Food and Drug Administration.

Drug Database URL: http://drug.fda.moph.go.th/zone_admin/admin119.asp

Provides Leaflets in Thai language only.

Pricing: Pricing is not available in the Database. Only Record retail drug prices is given (Open MS Excel) for representation purpose only.

URL: http://drug.fda.moph.go.th/zone_admin/admin71.asp

Thai database also provide the eCTD Feature with their customization

Drug eSubmission Project
Public Hearing Drug e-Submission project and eCTD Specification
eCTD Specification
Validation Criteria
Schema
FAQ

Laws and Regulations
- Notification of the electronic Common Technical Document (eCTD) for Thailand (TH)
appendix 1 TH eCTD Specification Module 1 and Regional Information V1.0 appendix 2 Document mapping from ACTD
appendix 3 TH Regional Specification and Validation Criteria V1.0
appendix 4 ICH eCTD

MHRA UK: Registered drug database

noreply@blogger.com (Unknown) — Thu, 19 Jan 2017 16:31:00 +0000

Collection

Marketing authorisations: lists of granted licences

From:

Medicines and Healthcare products Regulatory Agency

Part of:

Patient safety and Marketing authorisations, variations and licensing guidance

First published:

18 December 2014

Last updated:

11 January 2017, see all updates

Marketing authorisations (MAs) granted since January 2014.

Previous lists of granted licences are available on the National Archives website.

Documents

Marketing authorisations granted in December 2016
- 11 January 2017
- Decision
Marketing authorisations granted in November 2016
- 21 December 2016
- Decision
Marketing authorisations granted in October 2016
- 22 November 2016
- Decision
Marketing authorisations granted in September 2016
- 14 October 2016
- Decision
Marketing authorisations granted in August 2016
- 12 September 2016
- Decision
Marketing authorisation granted in July 2016
- 10 August 2016
- Decision
Marketing authorisations granted in June 2016
- 12 July 2016
- Decision
Marketing authorisations granted in May 2016
- 14 June 2016
- Decision
Marketing authorisations granted in April 2016
- 12 May 2016
- Decision
Marketing authorisations granted in March 2016
- 12 April 2016
- Decision
Marketing authorisations granted in February 2016
- 11 March 2016
- Decision
Marketing authorisations granted in January 2016
- 10 February 2016
- Decision
Marketing authorisations granted in December 2015
- 15 January 2016
- Decision
Marketing authorisations granted in November 2015
- 14 December 2015
- Decision
Marketing authorisations granted in October 2015
- 10 November 2015
- Decision
Marketing authorisations granted in September 2015
- 9 October 2015
- Decision
Marketing authorisations granted in August 2015
- 11 September 2015
- Decision
Marketing authorisations granted in July 2015
- 14 August 2015
- Decision
Marketing authorisations granted in June 2015
- 15 July 2015
- Decision
Marketing authorisations granted in May 2015
- 17 June 2015
- Decision
Marketing authorisations granted in April 2015
- 12 May 2015
- Decision
Marketing authorisations granted in March 2015
- 15 April 2015
- Decision
Marketing authorisations granted in February 2015
- 26 March 2015
- Decision
Marketing authorisations granted in January 2015
- 13 February 2015
- Decision
Marketing authorisations granted in December 2014
- 20 January 2015
- Decision
Marketing authorisations granted in November 2014
- 20 January 2015
- Decision
Marketing authorisations granted in October 2014
- 13 February 2015
- Decision
Marketing authorisations granted in September 2014
- 14 October 2014
- Decision
Marketing authorisations granted in August 2014
- 15 September 2014
- Decision
Marketing authorisations granted in July 2014
- 12 August 2014
- Decision
Marketing authorisations granted in June 2014
- 10 July 2014
- Decision
Marketing authorisations granted in May 2014
- 18 June 2014
- Decision
Marketing authorisations granted in April 2014
- 12 May 2014
- Decision
Marketing authorisations granted in March 2014
- 10 April 2014
- Decision
Marketing authorisations granted in February 2014
- 14 March 2014
- Decision
Marketing authorisations granted in January 2014
- 13 February 2014
- Decision

FDA Finalizes Guidance on Assessing Abuse Potential of Drugs | RAPS

noreply@blogger.com (Unknown) — Thu, 19 Jan 2017 16:11:00 +0000

FDA Finalizes Guidance on Assessing Abuse Potential of Drugs

Posted 18 January 2017 By Zachary Brennan

A guidance finalized on Wednesday, almost six years after it was first drafted, looks to help sponsors of investigational new drugs in evaluating whether their new drug product has abuse potential.

More specifically, the US Food and Drug Administration (FDA) says the 37-page guidance offers recommendations for assessing the abuse potential of central nervous system (CNS)-active new drugs and whether they produce euphoria (or other changes in mood), hallucinations, and effects consistent with CNS depressants or stimulants.- See more at:

Assessment of Abuse Potential of Drugs: Guidance for Industry

PHILIPPINES: DEPARTMENT OF HEALTH

noreply@blogger.com (Unknown) — Thu, 19 Jan 2017 15:51:00 +0000

REPUBLIC OF THE PHILIPPINES: DEPARTMENT OF HEALTH
http://www.doh.gov.ph/
Philippines Registered Drug database and drug price indicator both are integrated in a single well managed database by Department of Health of Republic of the Philippines.

Registered database provides the real time information and can be found on website search results with appropriate keywords. Database provides the following search results like:

1. Acquisition Cost

2. Quantity
3. Brand Name
4. Manufacturer
5. Supplier

Drug search pattern is equivalent to the BNF of UK i.e. Drug Search by BNF Therapeutic Categories.

Pricing:
A good transparency has been maintained by the MoH, Philippines. The following type of Drug prices has been give on website

Drug Price Watch For Consumer
Drug Price Reference for Government
2015 Drug Price Reference Index Booklet

Drug Price Reference Index (DPRI) for all essential medicines to guide is published annually. Latest version in pdf format is valuable for the year 2016.
Also old edition of the same are available on the website like;

DPRI Booklet
a. Drug Price Reference 2016
b. Drug Price Reference 2015
c. Drug Price Reference 2013
d. Drug Price Reference 2012

What is the Drug Price Reference Index (DPRI)? The DPRI lists the ceiling prices of essential medicines for government bidding and procurement set by the DOH for all National and Local Government Health Facilities and Government Agencies. Winning bid prices of essential medicines within the DPRI ceiling reflect efficient and effective procurement in the government. Their transparencies and enforcement ensure consumer access to medicines and protection from excessive price mark-ups on medicines. The DPRI only reflects the acquisition costs including landed cost, packaging, drug content, quality assurance, manufacturing overheads and Food and Drug Administration (FDA) fees. The DPRI excludes other costs such as pharmacy services, preparation and storage fees, and other reasonable pharmacy mark-ups, which are now being evaluated by the DOH. The DPRI aims to improve the efficiency and good governance in the pricing and procurement of medicines in the public sector through establishing a transparent and publicly available reference price for affordable and quality medicines. It also aims to guide the Philippine Health Insurance Corporation (PHIC) in setting reimbursement caps for medicines both for inpatient and outpatient services. Who should use the DPRI? All government entities should be guided by the DPRI when procuring medicines. It shall be applied to all forms of procurement such as public bidding, direct contracting, shopping, negotiated procurement, emergency procurement and consignment to ensure that the government achieves the best value for money in sourcing essential medicines.

Disclaimer: All prices reflected are based on the lowest bidding procurement price conducted last 2015 of all DOH Hospitals. All manufacturers/suppliers included in this website are FDA registered and has a certificate of current Good Manufacturing Practice (cGMP) issued by the FDA.

Languages: English

China: Food and drug Administration

noreply@blogger.com (Unknown) — Thu, 19 Jan 2017 14:36:00 +0000

China Food and drug Administration

Chinese Portal

English portal

Chinese Registered Drug database are well managed by the China Food and drug Administration.

Registered database provides the real time information and can be found on website search results with appropriate keywords under clicking the “DATA SEARCH”

There are many criteria under the drug search criteria like;

1. Domestic Drugs Database
2. Imported Drugs Database
3. Database of Drug Manufacturers in China
4. Database of GMP Certification
5. Database of approved Active Pharmaceutical Ingredients (APIs) and API manufacturers in China
6. Drug Manufacturing Certificate
7. Incomplete Lists of Vaccine Products

In database search can be done either basic and advanced. In advanced search many criteria are given by which search results can be found like;

Registration Certificate Number
Company Name (Chinese)
Company Name (English)
Product Name (Chinese)
Product Name (English)
Trade Name (Chinese)
Trade Name (English)
Manufacturer (Chinese)
Manufacturer (English)
Product Category
Drug Code

Also the results provides the detailed list of results of a particular product like;

· Registration Certificate Number
· The Original Registration Certificate Number
· Note of Registration Certificate Number
· Repackaging Approval Number
· Company Name (Chinese)
· Company Name (English)
· Address (Chinese)
· Address (English)
· Country/Region (Chinese)
· Country/Region (English)
· Product Name (Chinese)
· Product Name (English)
· Trade Name (Chinese)
· Trade Name (English)
· Dosage Form (Chinese)
· Strength (Chinese)
· Packaging Specification (Chinese)
· Manufacturer (Chinese)
· Manufacturer (English)
· Address of manufacturer (Chinese)
· Address of manufacturer (English)
· Country/Region of manufacturer (Chinese)
· Country/Region of manufacturer (English)
· Date of Issue
· Valid Until
· Name of Repackaging Enterprise
· Address of Repackaging Enterprise
· Approval Date of Repackaging Approval Number
· Repackaging Approval Number Valid Until
· Product Category
· Drug Code
Note of Drug Code

Pricing: not available.

Languages: English/ Chinese

Myanmar: DRUG SAFETY NETWORK/ Pharmacovigilance App

noreply@blogger.com (Unknown) — Tue, 17 Jan 2017 09:02:00 +0000

Android and iphone App

DRUG SAFETY NETWORK

Drug Safety Network is an ADR reporting application for both android and ios users, conceived by Food and Drug Administration, Myanmar.

With the help of Drug Safety Network application, doctors can instantly report any suspected Adverse Drug Reaction to Food and Drug Administration, Myanmar.

iPhone App
Android App

Details:
This app is designed for both iPhone and iPad
Free
Category: Medical
Released: Jan 05, 2017
Version: 1.0
Size: 7.5 MB
Language: English
©2017 Food and Drug Administration, Myanmar

Compatibility: Requires iOS 7.0 or later. Compatible with iPhone, iPad, and iPod touch.

Myanmar: Food and Drug Administration.

noreply@blogger.com (Unknown) — Mon, 16 Jan 2017 04:10:00 +0000

Food and Drug Administration, Myanmar

http://www.fdamyanmar.gov.mm/index.php/en/

Myanmar’s Food and Drug Administration provides the status of registered products in downloadable excel sheet. Database is easy to understand but detailed information is missing. Website also provide the registered product in the following categories

FOOD
DRUG
COSMETIC
MEDICAL DEVICES

The latest Approved Drug List available on website of June 2016.

List of overseas pharmaceutical drugs registered in Myanmar

Details
Created on Monday, 27 June 2016 11:25
Published on Monday, 27 June 2016 11:25
List of overseas pharmaceutical drugs registered in Myanmar
Download

In food registration category the following information is available on the website:
Food Additives (FA)
Details
Created on Friday, 22 August 2014 01:50
Published on Friday, 22 August 2014 01:50

Download the Food Import Health Certificate Data Spread Sheet related to Food Additives
1. FI-HC FA 13.xls
2. FI-HC FA 14 (NPt) 14.xls
3. FI-HC FA 14.xls
Download the Food Import Health Recommendation SpreadSheet related to Food Additives

Registerd Cosmetics details are as follows:

2016 Notified Cosmetics (Jan-Jun)
Details
Created on Wednesday, 20 July 2016 15:08
Published on Wednesday, 20 July 2016 15:08
Click Here to download 2016 Notified Cosmetics (Jan-Jun).

Notified Cosmetics 2015
Details
Created on Wednesday, 03 February 2016 14:58
Published on Wednesday, 03 February 2016 14:58

Click Here to download 2015 Notified Cosmetics.

2014 Notified Cosmetics
Details
Created on Thursday, 08 October 2015 17:26
Published on Thursday, 08 October 2015 17:26
Click Here to download 2014 Notified Cosmetics.

Renewal Certificate 2013-2015
Details
Created on Thursday, 08 October 2015 17:29
Published on Thursday, 08 October 2015 17:29
Click Here to download Renewal Certificate 2013-2015.

2013 Notified Cosmetics
Details
Created on Thursday, 08 October 2015 16:57
Published on Thursday, 08 October 2015 16:57
Click Here to download 2013 Notified Cosmetics.

Language: English

Pricing: Pricing information of registered products is not available on the website.

Published registered drug database provides the following results of each product.

Name of Drug
Owner/Manufacturer

Kenya Drug Pricing- "Drug-Index"

noreply@blogger.com (Unknown) — Fri, 13 Jan 2017 10:03:00 +0000

Drug-Index

There is one more authentic Drug pricing database where registration and login is must. This resource is equivalent to CIMS/ MIMS. The Company also publish hard copy of the same many times in the year.

http://drug-index.co.ke/search.php

This is a comprehensive and systematic source of drug information that has been customized to provide healthcare practitioners in the Eastern African region with easy-to-retrieve information on drugs and other related products.

DRUG CATEGORIES
It contains detailed information on the following: Drugs acting on infections and infestations, Drugs acting on alimentary system, Drug brands for the specific active agent, Drugs acting on the cardiovascular system, Drugs acting on central nervous system, Drugs acting on ear, nose and throat, Endocrine drugs, Drugs acting on genito-urinary system, Drugs affecting nutrition & metabolism, Drugs acting on respiratory system and Opthalmic drugs.

Language: English

Currency: KES/ USD

Distributors: This website also provide the information of Distributors available in Kenya, There complete info along with registered product has been given.

website provide the following services

A – Z DRUG INDEX
CLINICAL REFERENCE
RESEARCH DATABASE
DISTRIBUTORS

Kenya Drug price Index (KDPI)

noreply@blogger.com (Unknown) — Fri, 13 Jan 2017 09:21:00 +0000

Kenya Drug price Index (KDPI) database/ Transparency International

It is also supported by Transparency International, so it is a reliable source of the authentic drug pricing.

The Kenya Drug Price Index is a resource where you can access information concerning drugs that are consumed by the public in Kenya. Among the many useful tools provided, you can also be able to; list all the suppliers in the system, display medicine classes and the drugs from all the available suppliers, access the list of drugs a health facility should have in stock and so much more…

Language: English

Sort & Search Drug Prices Through:

Drugs Index — Catagories

All Drugs, Prices & Suppliers
Drug Class / Subclass Listing
Supplier Drug List & Prices

It is online database in which highest and lowest price and be seen.

The search results provide the following results.

Drug Name
formulation
strength
Use level
daily dose
DDD unit
comparison Unit
Supplier
Item price

Maldives

noreply@blogger.com (Unknown) — Fri, 13 Jan 2017 08:38:00 +0000

Maldives food and drug Authority, Ministry of Health, Republic of Maldives

http://www.mfda.gov.mv/

Maldivian food and drug Authority provides the status of registered drug products in downloadable pdf format. It is well managed for each registered product. Complete information of each product is given. Database is easy to understand. The latest Approved Drug List available on website of September 2016.

Maldives food and drug Authority's Database also provides the following information:

DOWNLOAD FILE

Language: English

Pricing: Pricing information of registered products is not available on the website.

Other product lists available as follows:

Approved Drug List October 2014
Approved Drug List September 2014
Approved Alternative Medicine/Dhivehi Beys List August 2014
Registered Pharmacy List August 2014
Approved Drug List 2014 August
Control Drug List (updated March 2014)
Approved Alternative Drug List March 2014
Approved Druglist 2014 March
Approved Druglist 2014 February
Approved Druglist 2014 January
Registered Pharmacy List September 2013
Approved Alternative Drug List August 2013
Approved Alternative Drug List July 2013
Un Approved Ultop Injection In The Market
Approved Drug List May 2013
Approved Drug List April 2013

Published registered drug database provides the following results of each product.

Serial Number
Product Number
Generic Name
Brand Name
Manufacture
Dosage Form
Strength
Category
Registration on Status
Essentiality
Reg Date Remarks (eg. Registered by Physician Request Form)

Category is divide as follows

OTC- Non prescription /over the counter medicine
POM -Prescription only medicine
r - Registered product
TR- Temporarily
Restricted for Hospital/Institutional use items only
Restricted for Hospital use only
E- Essential medicine
Restricted and to be used for the National programs only
Controlled

Regulatory Resources for Africa

noreply@blogger.com (Unknown) — Wed, 11 Jan 2017 15:42:00 +0000

It is a complete all in one resource for African guidelines and comparison of the Drug Registration requirements.

The Regulatory Resources for Africa website has been made possible by a non-prescriptive grant by Innovative Medicines South Africa (IMSA). The intention of the sponsors is to create a platform where up to date and useful information concerning the medicines regulatory environment in Africa, can be shared by all.

This is a collaborative initiative with the intention of benefitting all stakeholders, i.e. a voluntary association of individuals and groups working to develop a common resource of knowledge. While all reasonable attempts have been made to ensure the content is accurate and up to date, the site owners and sponsors cannot be held liable for inaccurate information or any harm or loss that may arise as a result of the use of the information provided on this website. Should you come across any information on this site which is not up to date or correct, please contact info@rrfa.org.za so that the matter can be evaluated / considered.

http://www.rrfa.co.za/

ZAZIBONA Collaborative Medicines Registration

noreply@blogger.com (Unknown) — Wed, 11 Jan 2017 15:23:00 +0000

ZAZIBONA Collaborative Medicines Registration

Alternative/Expedited process to register medicines
via the ZAZIBONA collaborative process
Version 1
9 June 2015

The ZAZIBONA process is a collaboration between national medicines regulatory authorities (NMRAs) in Botswana, Namibia, Zambia, and Zimbabwe. These are four neighbouring countries in Southern Africa which have a combined population of around 34 million. This process may be extended to include participation by other interested SADC Member States.

The vision of the ZAZIBONA process is :
• a region in which good-quality medicines are available to all those who need them;
• significantly reduce time taken to grant marketing authorisation in the individual countries; and
• efficient utilisation of resources within regional national regulatory through work sharing.

Downloads

African Proverb ~ If you want to go quickly, go alone. If you want to go far, go together.

http://www.rrfa.co.za/#inline_content

Malaysia:National Pharmaceutical Regulatory Agency (NPRA), earlier known as BFFK

noreply@blogger.com (Unknown) — Wed, 11 Jan 2017 13:31:00 +0000

Malaysian National Pharmaceutical Regulatory Agency (NPRA), earlier known as BFFK

http://npra.moh.gov.my/

Provides the status of registered drug products along with medical devices, cosmetics in online format. It is well managed for each registered product. Complete information of each product is given. Database is easy to understand.
Malaysian National Pharmaceutical Regulatory Agency’s Database also provides the following information

QUEST3+ System
QUEST 2 / QUEST 3 Online Submission System
1. Product Registration
2. Active Pharmaceutical Ingredient (API)
3. Veterinary
4. Cosmetic
5. GLP
6. Clinical Trials – Safety Reporting
7. GMP/GDP
8. Laboratory & Quality Control
9. Licensing
10. Pharmacovigilance - Product Registration Holders
11. Reporting by Consumers
12. ADR Reporting by Healthcare Professionals

LIST OF REGISTERED / NOTIFIED PRODUCTS
DRUG CONTROL AUTHORITY, MINISTRY OF HEALTH MALAYSIA
This database is a cumulative list comprising of drugs registered with the Drug Control Authority since 1985 and cosmetics notified with the Director of Pharmaceutical Services. This list consists of registration number / notification number, product name, name of product registration holder / notification holder and name of manufacturer only.

Search Instructions:
First, select the "Search By" from the drop-down menu below. The selections are searched by Product Name, Product Registration Number / Notification Number, Registration Holder / Notification Holder, Active Ingredient / Cosmetic Substance and Manufacturer. By default, if you do not select the "Search By" the system will search your query based on Product Name.

Enter the complete or a portion of the keyword of the criteria you are searching and click the "Search" button. (Eg. para, poll, ginseng, MAL2003 / NOT2003). For normal search criteria, please use the Search feature by clicking the button below.

For advance search criteria, please use the Advance Search feature by clicking the button below.

Starting from 1 January 2008, all cosmetic products are using Notification Number as a confirmation that product already meets the current local requirements. Details can be found under the Control of Cosmetic Products in Malaysia.

Product Type:

All Registered Product Other Than Cosmetics
Cosmetic Products Only

http://npra.moh.gov.my/index.php/about-npcb/npcb-info/quest3plus-product-search

Language: English/ Bahasu

Product Codes:
A: Scheduled Poisons
X: Non-scheduled Poisons (over the counter products)
T: Traditional Medicines
K/KE: Cosmetics
C: Contract Manufactured
E: Export Only
R: Repacked
S: Second source

Recommended Retail Price
Drug Control Authority (DCA) has decided at 110th meeting to include recommended retail price as a supplementary data for manufacturing and import licence application. These information would be useful as a guidance to the public. Where the Registrant has not provided the Bureau with updated RRP data, the database will display the price as "not available".

For Pricing details of registered drugs please see the earlier post as follows:

https://prtmnews.blogspot.in/search/label/Malaysia

Published registered drug database provides the following results of each product.

Product Name:

Holder:

Address:

Phone No:

Manufacturer:

Address:

Ingredients Information / Substance Name

Packaging Information/

Quantity

Algeria: Ministry of Health, Population and Hospital Reform

noreply@blogger.com (Unknown) — Tue, 10 Jan 2017 14:25:00 +0000

Direction Générale de la Pharmacie et des Equipements de Santé

http://www.sante.dz/

Algeria’s Directorate General of Pharmacy And Health Facilities publish status of registered drugs in downloadable formats (pdf) and it is well managed for each registered product. Complete information of each product is given. Database is easy to understand.

http://www.sante.dz/nomenclaure_26_06_2016.pdf

Algerian authority also provides the Expected needs in pharmaceuticals. Current it is available for the year - 2016.
http://www.sante.dz/prevision_prod_pharm_2016.htm

Websites also provide the Local manufacture of Medicines, currently the following database are available on the database.

Status of achievements

Year 2012 - - Year 2013
Year 2010 - - Year 2011

Language: French

Pricing: pricing of the drugs are not available on the online database.

Published registered drug database provides the following results of each product.

S. No
ATC Code
Name of API, Active Pharmaceutical ingredient
Brand Name / trade Name
Pharmaceutical form
Dosage
Packaging
Category
HOS/ private
LABORATORIES/ Manufacturer
HOLDER OF THE/ country
Date of Registration
Generic/ Branded
Status
Shelf life

Uganda: National Drug Authority (NDA) - Drug Register

noreply@blogger.com (Unknown) — Tue, 10 Jan 2017 13:27:00 +0000

National Drug Authority (NDA)

http://www.nda.or.ug/#

Online database is well managed each product information in each category are given online. Database is easy to understand. Information is available under the tab of “Drug register” on the website interface. Monthly registration database of each below mentioned categories can be downloaded in .pdf file under the section of “Downloads”.

Drug Register
This list is updated regularly when available data on such products are evaluated and relevant sites are inspected by National Drug Authority. Please enter the criteria below to display products from the Drug Register database.

This database provides the online list on the following categories.

Dietary
Health
Herbal Human
Herbal Vet
Human
Veterinary

Language: English

Pricing: pricing of the drugs are not available on the online database.

Online database provides the following results of each product.

Serial Number
Manufacturer
Drug Name
Number
Pack Sizes
Dosage Form
Applicant
Country of Origin
Importer

EudraPharma Database- A complete & Updated Registered Drug Database of whole Europe.

noreply@blogger.com (Unknown) — Mon, 09 Jan 2017 11:09:00 +0000

EudraPharma Database

EudraPharm Database is a complete data repository of whole Europe's registered drugs for Human & Veterinary drugs can be found in complete EU including UK.

About EudraPharm
EudraPharm is intended to be a source of information on all medicinal products for human or veterinary use that have been authorised in the European Union (EU) and the European Economic Area (EEA) and information on clinical trials of medicinal products including products with or without a marketing authorization. EudraPharm has been established to fulfil Articles 57(1)(l) and 57(2) of Regulation (EC) No 726/2004.

Use of this site is subject to terms and conditions specified on the EudraPharm Notices page, which also contains Copyright and Privacy Policy information.

Languages
EudraPharm is available in the following languages:
Bulgarian, Spanish, Czech, Danish, German, Estonian, Greek, English, French, Icelandic, Italian, Latvian, Lithuanian, Hungarian, Maltese, Dutch, Norwegian, Polish, Portuguese, Romanian, Slovak, Slovenian, Finnish, Swedish

Withdrawn Products
Companies sometimes withdraw medicines from the market, and they surrender their marketing authorisation. In such cases, EudraPharm may not show any details for the presentation or the product.

Current Functionality
EudraPharm currently provides the following functionality:

Display product information for all products approved via the Centralised Procedure, as well as for some products approved via national procedures (see Data Providers).

Display Product-Information Documents for all products approved via the Centralised Procedure. The documents contain Summary of Product Characteristics, Package Leaflet and Labelling information.

Search - find product by searching for a set category of product information.

A to Z Product List - browse product details indexed alphabetically by Product Name.

Advanced Search - find product by searching for specific categories of product information.

Access to data on clinical trials - EU Clinical Trials Register.

EudraPharm is being developed in stages. Therefore, the functionality and related support will increase in future.

Future Functionality
The following functionality will be available in the future:

Ability to search all categories of product information.
Ability to register with EudraPharm so that you can set your preferences.
Ability to register for e-mail updates.
Ability to view warnings and indications.
Ability to view product information customised to the requirements of Data Providers.

EudraPharm Data Providers
The product information contained in EudraPharm is collected from the following Data Providers:
National Competent Authorities.
European Medicines Agency.

Click on the name of the Data Provider listed below to view their website. Please note that:

The EudraPharm Data Providers are not responsible for the content of external websites.
The websites do not necessarily provide product information.
The websites are only provided as a reference for further information about the Data Providers.
If you find that a link is out of date, or broken, you are invited to e-mail the EudraPharm Helpdesk to allow us to rectify the issue: <eudrapharm@ema.europa.eu>

Product information from the following Data Providers can currently be viewed in EudraPharm:

Country/Body
EudraPharm Data Provider
European Union (EU)
European Medicines Agency

Ireland
Health Products Regulatory Authority
Italy
Ministero della Salute

Latvia
Zāļu valsts aģentūra
Netherlands
College ter Beoordeling van Geneesmiddelen

Portugal
INFARMED - Autoridade Nacional do Medicamento e Produtos de Saúde, I.P.

United Kingdom
Veterinary Medicines Directorate

France
Agence nationale de sécurité sanitaire de l'alimentation, de l'environnement et du travail – ANSES (Agence nationale du médicament vétérinaire - ANMV)
It is planned to include product information from the following Data Providers in the future:
Country/Body
EudraPharm Data Provider

Austria
Agentur für Gesundheit und Ernährungssicherheit - AGES

Belgium
Agence Fédérale des Médicaments et des Produits de Santé - AFMPS
Federaal Agentschap voor Geneesmiddelen en Gezondheidsproducten - FAGG
Föderale Agentur für Arzneimittel und Gesundheitsprodukte - FAAG

Bulgaria
Изпълнителна агенция по лекарствата
Национална ветеринарномедицинска служба
Cyprus
Υπουργείο Γεωργίας, Φυσικών Πόρων και Περιβάλλοντος (Κτηνιατρικές Υπηρεσίες)
Υπουργείο Υγείας της Κυπριακής Δημοκρατίας

Czech Republic
Státní ústav pro kontrolu léčiv
Ústav pro státní kontrolu veterinárních biopreparátů a léčiv

Germany
Bundesamt für Verbraucherschutz und Lebensmittelsicherheit - BVL
Bundesinstitut für Arzneimittel und Medizinprodukte - BfArM
Deutsches Institut für Medizinische Dokumentation und Information - DIMDI
Paul-Ehrlich-Institut - PEI

Denmark
Lægemiddelstyrelsen

Estonia
Ravimiamet
Greece
Εθνικός Οργανισμός Φαρμάκων - EOF
Spain
Agencia Española de Medicamentos y Productos Sanitarios - AGEMED

Finland
Lääkealan turvallisuus- ja kehittämiskeskus

France
Agence Française de Sécurité Sanitaire des Produits de Santé - AFSSAPS

Hungary
Mezőgazdasági Szakigazgatási Hivatal Központ Állatgyógyászati Termékek Igazgatósága - MgSzH ÁTI
Országos Gyógyszerészeti Intézet
Iceland
Lyfjastofnun
Italy
Agenzia Italiana del Farmaco - AIFA
Istituto Superiore di Sanità

Liechtenstein
Amt für Gesundheit

Lithuania Lietuvos Respublikos Valstybinè Maisto ir Veterinarijos Tarnyba
Valstybine vaistu kontroles tarnyba prie Lietuvos Respublikos sveikatos apsaugos ministerijos

Luxembourg
Ministère de la Santé, Direction de la Santé, Division de la Pharmacie et des Médicaments

Malta
Medicines Authority
Ministry for Rural Affairs and the Environment

Norway
Statens legemiddelverk

Poland
Urząd Rejestracji Produktów Leczniczych, Wyrobów Medycznych i Produktów Biobójczych

Portugal
Direcção Geral de Veterinária - DGV

Romania
Agentia Nationala a Medicamentului - ANM
Autoritatea Nationala Sanitara Veterinara si pentru Siguranta Alimentelor - ANSVSA

Sweden
Läkemedelsverket

Slovenia
Javna agencija Republike Slovenije za zdravila in medicinske pripomočke

Slovakia
Štátny ústav pre kontrolu liečiv - ŠÚKL
Ústav štátnej kontroly veterinárnych biopreparátov a liečiv

United Kingdom
Medicines and Healthcare products Regulatory Agency - MHRA

Sofosbuvir Pricing

noreply@blogger.com (Unknown) — Mon, 09 Jan 2017 09:44:00 +0000

Rapid reductions in prices for generic sofosbuvir and daclatasvir to treat hepatitis C

Andrew Hill, 1 Bryony Simmons, 2 Dzintars Gotham, 2 and Joseph Fortunak 3

Author information ► Copyright and License information ►

Abstract
Objectives:
Novel treatments for hepatitis C demonstrate high cure rates, but current high prices can be a barrier to rapid global treatment scale-up. Generic competition can rapidly lower drug prices. Using data on exports of raw materials in 2015, we calculated currently feasible generic prices of sofosbuvir and daclatasvir.

Methods:
Data on per-kilogram prices of sofosbuvir and daclatasvir active pharmaceutical ingredients (API) exported from India were extracted from an online database. To the cost of the amount of API needed for a 12-week treatment course, we added cost estimates for formulation (40%), packaging (US$0.35/month), and a mark-up (50%).

Results:
Between 1 January and 15 October 2015, over 5 tons of sofosbuvir were exported, with prices decreasing by US$702/kg/month, and observed prices of US$2501/kg in early September. Over the same period, 84 kg of daclatasvir were exported, with prices decreasing by US$1664/kg/month to US$1897/kg. Using the price estimation algorithm, we estimated the price of a generic sofosbuvir–daclatasvir combination regimen at US$200 per patient for a 12-week treatment course.

Conclusion:
The costs of generic production of sofosbuvir and daclatasvir are rapidly decreasing. Sofosbuvir–daclatasvir combination treatment could be produced for US$200 per patient per 12-week course.

Download link

Panama: Ministry of Health-List of Drugs in the process of Sanitary Registration

noreply@blogger.com (Unknown) — Sat, 07 Jan 2017 13:45:00 +0000

Ministry of Health, Panama

List of Drugs in the process of Sanitary Registration

Panama MoH although publish the registered drug database and they are also available on the Panama MoH website but the database is not updated till,date. However,can be downloaded for the year 2012, 2013, and 2014.

Information on registered drugs is available of registered products till 2014. The drug regulatory departments have the following documents available.

Pricing is not available in the MoH Database

Language: Spanish

Jamaica: Ministry of Health

noreply@blogger.com (Unknown) — Sat, 07 Jan 2017 13:13:00 +0000

Ministry of Health, Jamaica

http://moh.gov.jm/

Jamaican MoH although publish the registered drug database and they are also available on the Jamaican MoH website but the database is not updated till,date. However, in "word" files can be downloaded till December ,2014.

Information on registered drugs is available of registered products till 2014. The drug regulatory departments have the following documents available.

Pricing is not available in the MoH Database.

Language : English

Link

Peru: Special Recipes Authorized by DIGEMID

noreply@blogger.com (Unknown) — Sat, 07 Jan 2017 12:27:00 +0000

Special Recipes Authorized by DIGEMID

A BOTICAS, PHARMACIES AND PHARMACY SERVICES all the Boticas, Pharmacies and Pharmacy Services Communicates that date, Health Facilities that have AUTHORIZED BY SPECIAL RECIPES DIGEMID (Art 25th º023-2001 DS N-SA) for the Prescription and dispensing of drugs containing the substances included in lists IIA, IIIA, IIIB, and IIIC of Supreme Decree No. 023-201- SA, are as follows:

for details

http://www.digemid.minsa.gob.pe/Main.asp?Seccion=511

Peru: DIGEMID (Directorate General of Medicines, Supplies and Drugs/ Ministerio de Salud)

noreply@blogger.com (Unknown) — Sat, 07 Jan 2017 12:16:00 +0000

DIGEMID (Directorate General of Medicines, Supplies and Drugs/ Ministerio de Salud)

http://www.digemid.minsa.gob.pe/

Peru’s Registered Drug database and drug price databases both are very well managed by the DIGIMID (Ministerio de Salud de Peru).

Registered database provides the real time information and can be downloaded in both formats xls and pdf file.

http://observatorio.digemid.minsa.gob.pe/Precios/ProcesoL/Catalogo/CatalogoProductos.aspx

Pricing: is online with detailed information of the product has been given on website.
http://observatorio.digemid.minsa.gob.pe/

Languages: Spanish

Note: For English results kindly enable the Google translator.

Database xls/ pdf sheet provides the detailed information of the registered product.

Ministry of Health promotes use of Digital Recipe from May 2017

noreply@blogger.com (Unknown) — Sat, 07 Jan 2017 11:08:00 +0000

January 3, 2017. The Digital Recipe System will be available to health professionals from May this year for the issuance and dispatch of digital prescriptions for drugs classified as narcotic and psychotropic (known as "green recipe" and " Blue recipe ").

Ministry of Health promotes use of Digital Recipe from May 2017
It facilitates the issuance of recipes and the dispatch of the same.
Eliminates unnecessary paperwork and the use of paper
Improves control of the issuance and dispatch of addictive drug prescriptions
The digital recipe will be mandatory for the issuance of prescriptions of narcotic and psychotropic drugs

January 3, 2017. The Digital Recipe System will be available to health professionals from May this year for the issuance and dispatch of digital prescriptions for drugs classified as narcotic and psychotropic (known as "green recipe" and " Blue recipe "). This platform will allow the Ministry of Health to improve controls in the prescription and dispatch of these drugs and health professionals, pharmacies and drugstores to automate monitoring and allow the efficient dispatch of prescriptions.

For users, the digital prescription offers a number of advantages: there is no risk of losing the prescription and allows a direct interaction between the patient and the doctor.

The implementation of the Digital Recipe System is regulated by Executive Decree No. 39984-S of November 9, 2016: "Regulation for the Use and Operation of the Automated System of Digital Recipe for Psychotropic and Narcotic Drugs," promulgated by the Ministry of Health.

The decree modifies the way in which psychotropic and narcotic drugs are registered, notified and monitored. This means that from now on you will stop using prescription paper and you will be able to access your medicines just by presenting your identity card to a Health establishment.

The Ministry of Health communicates to health professionals (dentists, pharmacists and doctors), pharmacies, drugstores, laboratories and medical centers that must be prepared for the use of the system. The Ministry of Health in conjunction with Digital Government will be carrying out the following actions:

for more information:

https://www.ministeriodesalud.go.cr/index.php/noticias/noticias-2017/1069-ministerio-de-salud-impulsa-uso-de-la-receta-digital-a-partir-de-mayo-2017

Costa Rica: Ministerio de Salud de Costa Rica

noreply@blogger.com (Unknown) — Sat, 07 Jan 2017 10:53:00 +0000

Ministerio de Salud de Costa Rica

https://www.ministeriodesalud.go.cr/

Costa Rica’s Registered Drug database is very well managed by the Costa Rica’s Drug Regulatory Authority (Ministerio de Salud de Costa Rica).
Registered database is updated on monthly basis within a year and provides downloadable xls sheet for the following categories.
Registered product search is also available in the website year vise in the database.

· Foods
· Cosmetics
· Biomedical equipment and material
· Medicines
· Pesticides
· Natural products
· Hygiene products
· Hazardous chemicals
· Tattoo Inks

Pricing: is not available in the online database.

Languages: Spanish

Database xls sheet provide the detailed information of the registered product e.g.

COUNTRY
CONSECUTIVE
EXPIRATION
NAME REMARKS
MANUFACTURER SESSION
ARTICLE
PRODUCT TYPE
LABORATORIO HOLDER

Medicines section also provides the following information on the same page.

Medicines

Legislation
· Law No. 5395. General Health Law
· Decree 28466-S. Regulation of registration, control, importation and advertising of medicines
· See more regulation for medicines >>

Products registered

· List of registered drugs

Applications

· Request for the return of money (Not applicable for registrations in the System Register it).
· Instructions for completing the application form for the return of money

Medication registration

· Applications
o Application for registration of medicines
o Application for registration of biological medicines
o Radiopharmaceutical registration application form
o Application form for prior review of advertising of products of health interest

· Documents
o Receipt by deposit for paperwork
o Requirements for registration of medicines
o Press release DRPIS-UR-484-2015. Register of Medicinal Gases
o Press release DRPIS-UR-097-2015. Clarification on radiopharmaceutical registration
o Proof of submission of medication dossiers
o Interpretation of the power of legal representative and certification of the contract of manufacture of third parties for the sanitary registration of medicines
o Communiqué on "Procedure for the application of the single prevention"
o Circular DRPIS-1554-12-2013. Interested in advertising Products of Health Interest
o Press Release DAC-400-2012. Bioequivalence Study Requirements and Comparative Dissolution Profile Studies
o Communiqué DAC-UPS-004-C-2012. Re-establishment of the requirement of bioequivalence studies (207.5 kB)
o Circular DRC-913-09-08. Stability Study
o Circular DRC-911-09-08. Change in state control procedure
o Circular DRC-785-07-08. Certification of bioequivalence
o Circular DRC-106-01-07. Omission of photocopies of bibliographical citations that support the monograph
o Circular DRC-067-01-07. Users of the System of Registration of Medicines, Cosmetics, Natural Products, Food and Biomedical Equipment and Material

· Guides
o Validation guide for analytical methods
o Medication registration application compliance guide
o Medication Registration Request Filing Guide
o Guide for the technical evaluation of drug labeling
o Technical assessment guide for stability studies
o Guide for the technical evaluation of monographs
o Technical evaluation guide of clinical studies for the sanitary registration of medicines
o Guide to the technical evaluation of the qualitative quantitative formula for the sanitary registration of medicines

Post-medication changes

· Applications
o Request for post-registration changes to medicines

· Guides
o Guide to filling out the request for post-registration drug changes
o Guide to compliance with the request for post-registration changes to medicines

Renewal of medicines

· Applications
o Request for drug renewal

· Documents
o Affidavit on the stability study for the renewal of the registration of medicines
o Affidavit on the Quali-Quantitative Form for Renewing the Registration of Medicines
o Press Release DAC-UPS-12-09 - Renewal of Drug Registration (Nov 16, 2006)

· Guides
o Medication Replacement Request Filing Guide
o Guide to compliance with the application for renewal of registration of medicines

Technology/ Pharmacovigilance

noreply@blogger.com (Unknown) — Thu, 05 Jan 2017 10:51:00 +0000

Pharmacovigilance Electronic Reporting System

Pink and Yellow Forms

Apart from the online PV document submission, PPB has also develop and implemented the Reporting Tools (Download standalone applications for PC and Mobile installation) they are available and can be easily downloaded from PPB-PV website.

http://www.pv.pharmacyboardkenya.org/

Download the PV Desktop app (Windows Installer)
PV.exe

Download the PV Desktop app as a jar file (Linux/Mac OS)
PIV.jar

Download the PV Mobile app for Android
Android Installer

Download the PV Mobile app for app Nokia
Nokia Installer

Download Java Runtime Edition (java is required for the desktop application)
Java Installer

Technology

noreply@blogger.com (Unknown) — Thu, 05 Jan 2017 10:45:00 +0000

PPB Kenya Android App

PPB Android APP. Download and Open in your Android Phone to Install.

Download App:

PPB Android APP launched the Pharmacy and Poisons Board (PPB) app in April 2014.
The PPB app comes bundled with rich features that will safeguard Kenyan’s from counterfeit drugs as well as provide access to other vital information regarding drugs, pharmacists and other pharmaceutical professionals.

Using the PPB application one will be able to:

1. Access a list of all registered pharmacists and other pharmaceutical professionals
2. Access a database of all registered human and veterinary drugs and other drug information such as prescription, reaction and dosage.
3. Report suspected poor quality/counterfeit medicinal products. One can also report a suspected adverse drug reaction.
4. Search for chemists and pharmacies within a certain radius.
5. Plot the map and directions, also displays the official contacts.

The application also enables you to provide feedback and contact the Kenya Pharmacy and Poisons Board. It is currently available for Android on the Kenya Pharmacy and Poisons Board website. It will be coming soon on the Samsung App Store.

Ref: https://ilabafricastrathmore.wordpress.com/2014/04/29/pharmacy-and-poisons-board-app-launched/

Download the App and Open it in your Android Phone to Install
http://pharmacyboardkenya.org/downloads/?file=ppbAndroidApp.apk

Please note: this app is not available on Play Store, as it is third party app and not mapped with Google play store. When download click to the link and enable the third party installation in your android phone.