Thailand: Thai Drug Control Division (TDCD)

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:

1. Summary Product Characteristic (SPC) 
2. Registered Vaccine 
3. List by Trade Name
4. List by Importer
5. List by Manufacturer
6. List by Group of Vaccine
7. 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

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MHRA UK: Registered drug database

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.

Contents

1. Documents

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

Documents

1. Marketing authorisations granted in December 2016

   • 11 January 2017
   • Decision

2. Marketing authorisations granted in November 2016

   • 21 December 2016
   • Decision

3. Marketing authorisations granted in October 2016

   • 22 November 2016
   • Decision

4. Marketing authorisations granted in September 2016

   • 14 October 2016
   • Decision

5. Marketing authorisations granted in August 2016

   • 12 September 2016
   • Decision

6. Marketing authorisation granted in July 2016

   • 10 August 2016
   • Decision

7. Marketing authorisations granted in June 2016

   • 12 July 2016
   • Decision

8. Marketing authorisations granted in May 2016

   • 14 June 2016
   • Decision

9. Marketing authorisations granted in April 2016

   • 12 May 2016
   • Decision

10. Marketing authorisations granted in March 2016

    • 12 April 2016
    • Decision

11. Marketing authorisations granted in February 2016

    • 11 March 2016
    • Decision

12. Marketing authorisations granted in January 2016

    • 10 February 2016
    • Decision

13. Marketing authorisations granted in December 2015

    • 15 January 2016
    • Decision

14. Marketing authorisations granted in November 2015

    • 14 December 2015
    • Decision

15. Marketing authorisations granted in October 2015

    • 10 November 2015
    • Decision

16. Marketing authorisations granted in September 2015

    • 9 October 2015
    • Decision

17. Marketing authorisations granted in August 2015

    • 11 September 2015
    • Decision

18. Marketing authorisations granted in July 2015

    • 14 August 2015
    • Decision

19. Marketing authorisations granted in June 2015

    • 15 July 2015
    • Decision

20. Marketing authorisations granted in May 2015

    • 17 June 2015
    • Decision

21. Marketing authorisations granted in April 2015

    • 12 May 2015
    • Decision

22. Marketing authorisations granted in March 2015

    • 15 April 2015
    • Decision

23. Marketing authorisations granted in February 2015

    • 26 March 2015
    • Decision

24. Marketing authorisations granted in January 2015

    • 13 February 2015
    • Decision

25. Marketing authorisations granted in December 2014

    • 20 January 2015
    • Decision

26. Marketing authorisations granted in November 2014

    • 20 January 2015
    • Decision

27. Marketing authorisations granted in October 2014

    • 13 February 2015
    • Decision

28. Marketing authorisations granted in September 2014

    • 14 October 2014
    • Decision

29. Marketing authorisations granted in August 2014

    • 15 September 2014
    • Decision

30. Marketing authorisations granted in July 2014

    • 12 August 2014
    • Decision

31. Marketing authorisations granted in June 2014

    • 10 July 2014
    • Decision

32. Marketing authorisations granted in May 2014

    • 18 June 2014
    • Decision

33. Marketing authorisations granted in April 2014

    • 12 May 2014
    • Decision

34. Marketing authorisations granted in March 2014

    • 10 April 2014
    • Decision

35. Marketing authorisations granted in February 2014

    • 14 March 2014
    • Decision

36. Marketing authorisations granted in January 2014

    • 13 February 2014
    • Decision

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FDA Finalizes Guidance on Assessing Abuse Potential of Drugs | RAPS

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

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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

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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

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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.

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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

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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

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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

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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 

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