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W-04: Understanding Safety Reporting Requirements: Perspectives from Asia, US and Europe

Poster Presenter

Mugdha Chopra

Co-Founder and Director
AWINSA Life Sciences
United States

Objectives

The objective of the study is to -Understand the dilemmas and issues faced when applying the principles of Clinical safety and Pharmacovigilance in Asian countries. -Compare regulatory environments in Asian countries to those in the US and EU and explore measures to manage complexities.

ORAL PRESENTATION: 12:50PM

Method

A review of the regulatory and Clinical trial PV systems literature with a focus on the Asia Region was done. A comprehensive assessment of the safety reporting requirements in China, Japan, Korea, Taiwan and Singapore was done to understand the differences and similarities amongst them

Results

There is a considerable heterogeneity and diversity in the regulatory requirements of the participating countries. To exemplify, a local representative is quintessential in China, Japan, Taiwan while that is not the case in some of the other countries. Further the translation of SUSARs to the local language is obligatory in some countries like Japan and South Korea however English version is still acceptable in many others. Expedited time frames for all countries is 7/15 except India where it is 14 days. Unblinding is required in EU/US, Japan and Singapore for Sponsors for reporting to Regulatory Authorities, but not required in other countries. Differences also exist in the mode of submission of reports with different countries opting for manual submission/in person submission or electronic submission. In terms of aggregate reports, while DSUR is required for submission to RAs in the US (IND annual report unless waiver for DSUR), EU, Japan and South Korea, most of the countries just require some progress reports with no clear template. The variations are not limited to the above-mentioned examples but extend across many other nuances in the modus operandi of Pharmacovigilance.

Conclusion

Asia is the fastest growing pharmaceutical market in the world, providing substantial opportunities for drug development and marketing. Pharmacovigilance being a very sensitive issue demands a high degree of regulatory expertise especially in Global clinical trials. There are numerous differences in the drug regulations within the different countries of Asia. It has been a continuous challenge to harmonize the pharmacovigilance regulations in clinical trials in Asia due to diverse geographical, cultural and clinical practices in this region. While the West has witnessed major developments in pharmacovigilance, not much has been observed in Asian countries. However, with more clinical trials and clinical research activity being conducted in Asia, there is an important requirement to streamline pharmacovigilance processes. Adhering to the strict regulatory timelines for all the participating countries is a big challenge. Extensive knowledge of the modus operandi of ethics committees and Regulatory authorities plays a crucial role in achieving the highest standards in patient safety.