Thailand
Regulatory . Certification . Licensing . Assurance
Our Markets
Why Thailand
Thailand is one of the larger economies within ASEAN and has been an active participant in the regional economic and political landscape. Thailand's pharmaceutical market, valued at around 188 billion Thai baht or $6.4 billion, is a very attractive market for Pharmaceutical companies. The Thai FDA, under the Ministry of Public Health, regulates the market, ensuring safety and quality.
Foreign pharmaceutical companies looking to register their products in Thailand must appoint a local representative to facilitate communication with the TFDA and ensure compliance with all regulatory requirements. The Thai authorities often have stringent documentation requirements for drug registration where the preparation and submission of administrative documents, translating and preparing the dossier in compliance with local requirements and GMP clearance can pose a significant challenge. Identifying a reliable and qualified local representative can be a crucial factor to the successful registration with TFDA.
Regulatory policies in Thailand are constantly being updated, impacting the drug registration process. Companies need to stay abreast of any policy changes and adapt their strategies accordingly.
Despite the regulatory complexities, the market is expected to grow due to factors such as the increasing incidence of chronic non-communicable diseases, expansion of universal health coverage, and a rise in the number of foreign patients seeking treatment in Thai hospitals.
