Thailand amends law on registration of new drugs

Thailand’s Food and Drug Administration is tightening requirements and raising fees for the registration of new drugs.

The changes were published in Thailand’s Government Gazette in April as Drug Act (No. 6) B.E. 2562 and go into effect in October, 2019. They mandate:

  • Manufacturers of modern drugs include the publication numbers of published patent or petty patent applications in their drug registration dossier.
  • Manufacturers of traditional drugs show the registration of right concerning Thai traditional medicine in accordance with the Protection and Promotion of Traditional Thai Medicine Knowledge Act.
  • Drug registration certificates be renewed every seven years. Previously, the certificates did not expire.

The new law also increases penalties for failing to comply with regulations on drug research. Thai officials can temporarily suspend, completely stop or order improvements to drug research studies found in violation of the country’s published guidelines. Violations are subject to hefty fines.