Abstract
A well-developed pharmacovigilance system adopted in clinical trials is a key to success. However, countries are continuously updating relevant information due to the fast-changing regulatory environment. The conduct of pharmacovigilance activities in international trials has become challenging. Recognizing the importance of understanding national pharmacovigilance systems’ performance, this narrative overview is to compare the existing pharmacovigilance system in the United States, the United Kingdom, Ireland, and Australia.
A narrative review of English-language articles focusing on pharmacovigilance in clinical trials.
This review provides in-depth insights to enhance the collaboration of global trials in line with current pharmacovigilance regulations.
The narrative review identified the differences in pharmacovigilance from the sponsor's perspective in individual countries and found that each country has well-developed governance structures, and national centres, for pharmacovigilance that was mandated by legislation. In terms of bioequivalence clinical trials for generic drugs, only the USA published specific guidance for public use. (Administration, 2021) For safety data transformation, Ireland will be the first country to mandate E2B(R3) from June 2022. The concept of “low-intervention clinical trial” is first introduced in the EU 536/2014. As the UK and Australia still follow the structure of EU RMP, they might change the risk category in the future. (Authority, 2022, Agency, 2021) Overall, a comprehensively understanding of pharmacovigilance is vitally important to conducting global trials.
A narrative review of English-language articles focusing on pharmacovigilance in clinical trials.
This review provides in-depth insights to enhance the collaboration of global trials in line with current pharmacovigilance regulations.
The narrative review identified the differences in pharmacovigilance from the sponsor's perspective in individual countries and found that each country has well-developed governance structures, and national centres, for pharmacovigilance that was mandated by legislation. In terms of bioequivalence clinical trials for generic drugs, only the USA published specific guidance for public use. (Administration, 2021) For safety data transformation, Ireland will be the first country to mandate E2B(R3) from June 2022. The concept of “low-intervention clinical trial” is first introduced in the EU 536/2014. As the UK and Australia still follow the structure of EU RMP, they might change the risk category in the future. (Authority, 2022, Agency, 2021) Overall, a comprehensively understanding of pharmacovigilance is vitally important to conducting global trials.
| Original language | English (Ireland) |
|---|---|
| Title of host publication | UK CRF Network |
| Publication status | Published - 2022 |