Measuring progress in regulatory convergence and cooperation among Asia-Pacific Economic Cooperation (APEC) member economies in the context of the COVID-19 pandemic
This article was originally published here
Ther Innov Regul Sci. April 11, 2021 doi: 10.1007 / s43441-021-00285-w. Online before printing.
OBJECTIVE: Regulatory convergence and cooperation between medical product regulatory authorities is essential to rapidly deliver safe and effective products 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 the availability of vaccines, treatments and diagnostics COVID-19 and to maintain the availability of 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 21 APEC member economies. Key performance indicators (KPIs) were developed in 2018 to measure convergence.
RESULTS: This article presents the survey results gathered from the KPI tracking in March 2020 with medical product regulatory authorities in the 21 APEC economies regarding 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 regulators in APEC member economies sharing Good Manufacturing Practices (GMP) certificates and a 28% increase the number of regulatory authorities accepting multi-site licenses during the same period. In addition, this article explores how the APEC economies could achieve a maximum level of regulatory convergence and cooperation.
CONCLUSIONS: Convergence efforts within APEC can accelerate the availability of medical products, including those related to COVID-19 vaccines, treatments and diagnostics, while maintaining the availability of existing medical products unrelated to vaccines and the COVID-19 treatment. New KPIs and capacity building must be considered to enable a new era of innovation ushered in by COVID-19.
PMID: 33840083 | DOI: 10.1007 / s43441-021-00285-w