The Philippines will soon be adopting the ASEAN Common Technical Dossier (ACTD) and Common Technical Requirements (ACTR) for pharmaceutical registration. There is currently no set date for this implementation, but the Department of Health has already released a draft administrative order. Pharmaceutical manufacturers, traders, exporters, exporters, importers, and wholesalers would all need to abide by this new administrative order when fully executed.
The ACTD has multiple sections including a glossary, table of contents, quality data, nonclinical data and study reports, clinical data and study reports and more. The ACTR includes guidelines on the drug’s stability study, manufacturing process validation data, validation of analytical procedures, conduct of bioavailability and bioequivalence studies, etc.
The aim is to improve the state of public health by allowing more effective drugs to reach the Filipino population sooner. These changes should streamline the drug registration process in the Philippines.