DRUG REGULATORY AFFAIRS INTERNATIONAL
http://www.fda.moph.go.th/eng/index.stm
[PDF]Regulatory Requirement for the Approval of generic Drug in Thailand …
Apr 13, 2014 – Thailand has its own drug registration format and also follows. ASEAN CTD. … Transparency in the regulatory authorities of member countries.
THAILAND PHARMACEUTICAL REGISTRATION AND APPROVAL
The Thai FDA (TFDA), one of several agencies under the Ministry of Public Health (MPH), is the regulatory body administering drugs in Thailand. The Drug Control Division of the TFDA is responsible for registration, licensing, surveillance, inspection and adverse event monitoring for all pharmaceuticals and pharmaceutical companies in Thailand. Foreign pharma companies dominate the Thai drug market. Due in part to trade negotiations, regional harmonization and positive economic trends, the pharmaceutical market in Thailand is predicted to double by 2022.There are several versions of the Drug Act currently in effect, and the Thai government is working on a revised version with updated regulations. Under the current…
View original post 553 more words
Filed under: Uncategorized