The ASEAN announces moves to harmonize drug registration procedures
The Association of Southeast Asian Nations (ASEAN) has mandated the filing of an ASEAN Common Technology Dossier (ACTD) as the only regulatory filing for pharmaceutical companies to get approval for their drugs in the 10-member states of Singapore, Malaysia, Indonesia, Philippines, Thailand, Vietnam, Brunei, Myanmar, Cambodia and Laos, with effect from 2012.
The latest move comes after a meeting last May of ASEAN countries, when they reached agreement to harmonize standards and regulations of pharmaceutical products. The three principle aims were to: create a transparent regulatory process; standardize regulation requirements; and remove the need for duplicate studies to meet various regulation requirements, thereby allowing drug companies more time and resources for R&D on new drugs.
Opportunity for Indian drugmakers
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