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

Tweet