19 Jan 2017

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

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

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

17 Jan 2017

Myanmar: DRUG SAFETY NETWORK/ Pharmacovigilance App

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.

16 Jan 2017

Myanmar: Food and Drug Administration.

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

13 Jan 2017

Kenya Drug Pricing- "Drug-Index"

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)

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

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

11 Jan 2017

Regulatory Resources for Africa

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

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

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

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