Measuring Progress of Regulatory Convergence and Cooperation Among Asia-Pacific Economic Cooperation (APEC) Member Economies in the Context of the COVID-19 Pandemic

Abstract

Purpose: Regulatory convergence and cooperation among medical product regulatory authorities are essential to delivering safe and efficacious products quickly to patients. The COVID-19 pandemic highlights the urgent need for streamlined regulatory approval processes-which can be achieved in part through regulatory convergence and cooperation-both to accelerate availability of COVID-19 vaccines, treatments and diagnostics and to maintain the availability of the existing medical products unrelated to COVID-19.

Methods: The Asia-Pacific Economic Cooperation (APEC) Life Sciences Innovation Forum (LSIF) established the Regulatory Harmonization Steering Committee (RHSC) in 2008 to advance regulatory convergence among APEC's 21 member economies. Key performance indicators (KPIs) were developed in 2018 to measure convergence.

Results: This paper reports survey results collected from KPI tracking in March 2020 from medical product regulatory authorities in all 21 APEC economies concerning areas of regulatory practice in which they could converge and cooperate. For example, from 2008 to 2020, there was a 14.3% increase in the number of APEC member economy regulatory authorities sharing Good Manufacturing Practices (GMP) Certificates and a 28% increase in the number of regulatory authorities accepting multisite licenses in that same period. In addition, this paper explores how APEC economies could realize a maximum level of regulatory convergence and cooperation.

Conclusions: Convergence efforts within APEC can accelerate availability of medical products including that related to COVID-19 vaccines, treatments and diagnostics, while maintaining the availability of the existing medical products unrelated to COVID-19 vaccines and treatment. New KPIs and capability building are to be considered to enable a new era of innovation ushered in by COVID-19.

Keywords: APEC; COVID-19; Key performance indicators; Regulatory convergence; Regulatory cooperation.

Fig.1

Increase in ICH and PIC/S membership among the APEC economies from 2008 to 2020

Fig. 2

Full analysis of APEC economies ICH membership status in 2019

Fig. 3

Full analysis of APEC economies PIC/S membership status in 2019

Fig. 4

52% of APEC economies remove CPP since it is no longer used to replace full or partial review

Fig. 5

More than 85% of APEC economies accept other RAs’ GMP certificates to reduce inspection load

Fig. 6

Reliance and mutual recognition arrangement exist among APEC economies to minimize duplication in inspection regardless of their PIC/S status

Fig. 7

More than 70% of APEC economies practice multi-sites-in-a-license

Fig. 8

More than 50% of the APEC economies utilize reliance pathways

Fig. 9

52% (11 economies) of APEC economies require secondary testing, out of which 1 economy can grant testing exemption based on reliance practices

Fig. 10

Reliance models that exist among the APEC economies