PNS262 GLOBAL TRENDS IN REGULATORY LEGISLATION FOR POST MARKETING SURVEILLANCE (PMS) REAL-WORLD EVIDENCE (RWE) STUDIES AND THE SECONDARY USE OF HEALTH DATA IN PMS STUDIES.

Abstract

Describe regulatory legislation for PMS RWE studies, and the secondary use of health data including administrative, electronic health record (EHR) and claims databases in PMS studies in Europe and seven AsiaPacific and Latin American countries. We reviewed local country regulatory websites and the European Network of Centers for Pharmacoepidemiology and Pharmacovigilance (ENCePP) website. We also searched for relevant publications in PubMed from January 2015 to December 2018. In Europe, 18/28 countries have specific legislation for the secondary use of health data. The number of data sources available rose from 83 in 2017 to 134 in 2019 (61% increase), supporting about 140 PASS in 2017 and 193 in 2019. The majority of regulatory decision making is based on only 34 databases in 13 EU countries. Similar to many EU countries, Brazil, India, Japan, mainland China, Mexico, South Korea, and Taiwan, request PMS RWE. In Asia and Mexico, the trend is to request primary data collection of exposed patient cohorts with prospective follow-up, also in Japan, South Korea, and Taiwan, where comprehensive national databases are available. In Brazil, there has been an increase in the use of structured databases to generate RWE for PMS in 2018. Regulators have been and will likely increasingly accept or request secondary use of health data in PMS studies to observe drug effects in routine practice conditions and larger and more diverse populations, provided the studies use fit for purpose databases, assessed by experts in the field who use correct methodologies and validation where needed. Existing comprehensive and representative EHR/claims databases available in Brazil, Japan, South Korea, and Taiwan, are expected to be used more in PMS studies. We eagerly anticipate regulatory secondary use of health data guidance documents in Asia, several EU countries and Latin America.