APEC Workshop Report of Good Review Practices on Medical Products

As part of the implementation of the 2020 Good Review Practices (GRevP) Roadmap championed by Chinese Taipei in the Asia-Pacific Economic Cooperation (APEC) Regulatory Harmonization Steering Committee (RHSC), the Taiwan Food and Drug Administration (TFDA) organized 2 workshops. The purpose of these workshops was to address the fundamental elements of a well-designed regulatory review system, to provide complementary modules for GRevP and approaches to the exchange and the use of product assessment reports between regulatory authorities, and to further promote regulatory efficiencies and best practices. The workshops brought together 81 regulatory representatives from 15 economies for the basic workshop and 133 from 20 economies for the advanced workshop. Participants forged a common understanding of GRevP and highlighted its importance. While the adoption of GRevP is key to building trust between agencies, each economy should address its needs and adopt its own best practices based on its resources and environment. The outcomes of these workshops could be used as a framework for the development of a GRevP best-practice document or could serve as material for further training in each economy.

Source: Therapeutic Innovation and Regulatory Science - June 29, 2015 Category: Drugs & Pharmacology Authors: Lin, H.-Y., Chen, S. J.-Y., Gau, C.-S., Liu, L.-L. Tags: Regulatory Science Source Type: research