W 01: Clinical Development in Regulated and Unregulated Markets: Understanding Safety Reporting Requirements
Vice President-PV and Clinical Safety North America and Global Medical Affairs
APCER Life Sciences United States
The objective of the study was to understand the important differences in pharmacovigilance regulations for clinical trials in Asia and other developing countries, compare these regulatory environments to those in the US and EU, and explore measures to manage complexities.
A review of the regulatory and clinical trial PV systems literature was done. A comprehensive assessment of the safety reporting requirements in China, Japan, Korea, Taiwan, Singapore and some of the other countries in Asia was done to understand the differences and similarities amongst them.
While the West has witnessed major developments in pharmacovigilance, not much has been observed in Asian countries. The study revealed that there is considerable heterogeneity and diversity in the regulatory requirements of the participating countries and a precise knowledge is necessary to streamline pharmacovigilance operations.
To exemplify, a local representative is quintessential in China, Japan, and 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 such Japan and South Korea; however, English version is still acceptable in many others. Differences also exist in the mode of submission of reports with different countries opting for manual submission/in person submission or electronic submission. The variations are not limited to the above mentioned examples but extend across many other nuances in the modus operandi of pharmacovigilance.
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. Harmonizing pharmacovigilance regulations in clinical trials has been a continuous challenge due to diverse geographical, cultural and clinical practices in this region. However, with more R&D activities conducted in Asia, there is an important requirement to streamline pharmacovigilance processes. Extensive knowledge of the modus operandi of ethics committees plays a crucial role in achieving the highest standards in patient safety.