Navigating Biologic Product Registration in Thailand: TFDA Requirements, Procedures, and Validation Process
TFDA Requirements for Summary Product Characteristic (SPC) Thailand, governed by the Drug Act B.E.2510. The key points are as follows 1. Legal Basis and Scope Article 79 of the Drug Act mandates that no drug can be manufactured or imported into Thailand without obtaining marketing authorization from the Thai Food and Drug Administration (TFDA). Articles 80, 81, and 82 of the Drug Act specify the application dossier requirements, including quality, non-clinical, and clinical infor...
