Thailand Pharmaceutical Registration and Approval

Under the Thailand Ministry of Public Health (MOH), the Thai FDA (TFDA) is the regulatory body overseeing drugs.  Within the TFDA, the Drug Control Division provides surveillance over pharmaceutical companies and pharmaceuticals and is in charge of Thailand’s pharmaceutical and drug registration. The Drug Control Division is also involved with drug inspection and receiving adverse event reports. 
To register a drug in Thailand, a complete marketing authorization application, along with samples, must be submitted to the TFDA for review. The Association of Southeast Asian Nations (ASEAN) has also issued requirements for an ASEAN CTD too.  If a drug license is not issued, applicants can appeal Thai drug registration decision within 30 days.
When submitting a Thai drug application, the Applicant also needs to let the TFDA know where
the product has been approved already.  If the drug is approved in the US, EU, Japan, or
Australia, it will be easier to register in Thailand. It is also important to renew the marketing
authorization for each drug product. Government fees for drug registration in Thailand are not
Pharmaceuticals in Thailand are put in 4 different classes for product registration including – 1. OTC drugs, which can be sold without a RX, 2. Pre-packaged drugs that also do not need a RX but need to be apportioned by a medical professional, 3. Dangerous drugs that can be sold without a RX but need to be apportioned by a pharmacist, and 4. Specially controlled drugs that can be sold via a RX and may cause damage if not used correctly. 

To distribute registered drugs in Thailand, an import or manufacturing license must be obtained by a pharmaceutical company or its Thai distributor. This license allows them to import or sell drugs in the country. The Thai drug license needs to be renewed annually, and it remains valid from January 1 to December 31 every year.  Once a Thai import license has been obtained, applicants must also receive authorization to import drug samples.  It is not legal to market drugs on-line. While most drugs in Thailand do not require a RX, only licensed dentists and doctors can prescribe drugs. 
Thai drug RX ads can only be directed to professionals in the medical space. Specialty or dangerous drug ads cannot be advertised to consumers.  Another organization that supervises drug marketing and advertising is the Thai Pharmaceutical Research and Manufacturers Association (PRMA).  This group also has a code that outlines specific guidelines on these activities.

To learn more about how PBM can help you register your drug products in Thailand, please contact us.