Developing key performance indicators to measure the progress of regional regulatory convergence and cooperation in Asia-Pacific Economic Cooperation (APEC)

Sannie Siaw Foong Chong,John C W Lim ,Toshiyoshi Tominaga

doi:10.1186/s41120-018-0024-2

Abstract

Regulatory convergence and cooperation among the authorities in the field of medical products (medicines and medical devices) are essential to deliver safe and efficacious products quickly to patients. APEC established the Regulatory Harmonization Steering Committee (RHSC) to advance this cause among member economies. This paper identifies four areas of appropriate regulatory practice in which APEC economies could converge, and explores the feasible processes of how APEC economies could cooperate in order to bring about realization of a maximum level of regulatory convergence by 2020.

Highlights

Since the inception of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) in 1990, harmonization of regulatory requirements has been progressively and successfully achieved in major jurisdictions around the world
This paper identified four areas of appropriate regulatory practice in which Asia Pacific Economic Cooperation (APEC) economies could converge
While working towards attaining Pharmaceutical Inspection Convention (PIC)/S membership and to manage issues of scarce resources and expertise, APEC economies could consider adopting more risk-based approaches that leverage on evaluations conducted by stringent regulatory authorities, and focusing their regulatory resources on issues that are of locally critical significance

Summary

Introduction

Since the inception of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) in 1990, harmonization of regulatory requirements has been progressively and successfully achieved in major jurisdictions around the world. Regulatory convergence represents a voluntary process whereby the regulatory requirements across economies become more similar or “aligned” over time as a result of the gradual adoption of internationally recognized technical guidance documents, standards and scientific principles (harmonization) and common or similar practices and procedures.

Results

Conclusion