Upcoming ASEAN Pharmaceutical Harmonization
The Association of South East Asian Nations (ASEAN) is preparing for the upcoming implantation of the ASEAN Common Technical Dossier (ACTD) in January 2009. Drafted by the Pharmaceutical Product Working Group (PPWG) of the ACCSQ (ASEAN Consultative Committee on Standards & Quality), the ACTD is a guideline of agreed upon common format for pharmaceutical registration.
The Common Technical Document is organized into four main parts as follows:
- Table of Contents, Administrative Data, and Product Information
- Quality Document
- Nonclinical Document
- Clinical Document
The first part consists of mostly administrative data and general product information, such as application forms, labels, package inserts, mode of action, side effects, etc. The second part contains quality control information, while the third part covers data on pharmacology, pharmacokinetics and toxicology. The last part consists of the Clinical Overview and Clinical Summary.
The latest ACCSQ PPWG meeting was held in Brunei in July 2008, where the Minister of Health emphasized the importance of free markets by removing technical barriers through ASEAN harmonization. The next meeting will be hosted by the Philippines in May 2009.
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