Article ; Online: Asia Partnership Conference of Pharmaceutical Associations (APAC) Report on Regulatory Agility Implemented During the COVID-19 Pandemic: Inspiring Partnerships and Recommendations for the Way Forward.
Therapeutic innovation & regulatory science
2022 Volume 57, Issue 1, Page(s) 12–25
Abstract: Purpose: Asia Partnership Conference of Pharmaceutical Associations (APAC) promote regulatory agility of four important best practices i.e. reliance, digital platform, accepting electronic document and process integration. Dialogues and strong ... ...
| Abstract | Purpose: Asia Partnership Conference of Pharmaceutical Associations (APAC) promote regulatory agility of four important best practices i.e. reliance, digital platform, accepting electronic document and process integration. Dialogues and strong partnership witnessed reforms and efficiencies amidst the pandemic. In tracking the progress of regulatory agility, APAC identifies areas for improvement and recommends prioritizing these areas for change. Methods: As one voice, 13 main industry associations under the umbrella of APAC sent joint letters to our National Regulatory Authorities (NRAs) with a call to maintain regulatory agility and consider new ways of working. Consequently, APAC surveyed its member associations to measure regulatory agilities implemented by the NRAs during 2020 and 2021 in view of the pandemic. Results: This paper reports progress in implementing regulatory agility, e.g. the number of economies that can accept electronic Certificate of Pharmaceutical Products (eCPP) has reached 100% for the economies that require CPP and more than 90% can waive onsite inspection in the presence of Good Manufacturing Practice (GMP) certificate and/or inspection report. The paper also features the progress made in Malaysia, the Philippines, and the ASEAN (Association of South East Asian Nations) regional reliance initiative to reduce inefficiencies and duplications. Conclusions: We have demonstrated the power of working together to enable regulatory agilities and efficiencies. APAC will continue to track the progress of all economies including India within the areas for improvement prioritized and discussed in this paper. APAC is also committed to working with key stakeholders including our NRAs in Asia to sustain and enable a new era of innovation ushered in by COVID-19 to benefit patients. |
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| MeSH term(s) | Humans ; Pandemics ; COVID-19 ; Asia ; Commerce ; Pharmaceutical Preparations |
| Chemical Substances | Pharmaceutical Preparations |
| Language | English |
| Publishing date | 2022-09-29 |
| Publishing country | Switzerland |
| Document type | Journal Article ; Research Support, Non-U.S. Gov't |
| ZDB-ID | 2708397-4 |
| ISSN | 2168-4804 ; 2168-4790 |
| ISSN (online) | 2168-4804 |
| ISSN | 2168-4790 |
| DOI | 10.1007/s43441-022-00435-8 |
| Database | MEDical Literature Analysis and Retrieval System OnLINE |
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