Article ; Online: Measuring Progress of Regulatory Convergence and Cooperation Among Asia-Pacific Economic Cooperation (APEC) Member Economies in the Context of the COVID-19 Pandemic.
Therapeutic innovation & regulatory science
2021 Volume 55, Issue 4, Page(s) 786–798
Abstract: ... Methods: The Asia-Pacific Economic Cooperation (APEC) Life Sciences Innovation Forum (LSIF) established ... through regulatory convergence and cooperation-both to accelerate availability of COVID-19 vaccines, treatments and ... member economies. Key performance indicators (KPIs) were developed in 2018 to measure convergence ...
| 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. |
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| MeSH term(s) | Asia ; COVID-19 ; COVID-19 Vaccines ; Humans ; Pandemics ; SARS-CoV-2 |
| Chemical Substances | COVID-19 Vaccines |
| Language | English |
| Publishing date | 2021-04-11 |
| Publishing country | Switzerland |
| Document type | Journal Article |
| ZDB-ID | 2708397-4 |
| ISSN | 2168-4804 ; 2168-4790 |
| ISSN (online) | 2168-4804 |
| ISSN | 2168-4790 |
| DOI | 10.1007/s43441-021-00285-w |
| Database | MEDical Literature Analysis and Retrieval System OnLINE |
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