PNS138 TRANSNATIONAL COLLABORATIONS AMONG DRUG REGULATORY AGENCIES: TRENDS AND FUTURE PERSPECTIVES

Abstract

Diversity in regulatory standards globally makes the drug development complex. Different international initiatives were put in place to support the harmonization in drug regulation to optimize drug development and drug authorization. Study aim was to evaluate the trends in the transnational collaborations between drug regulatory agencies and future perspectives. A comprehensive literature review was conducted in websites of regulatory agencies (EMA, US FDA, TGA and Health Canada), websites of International Council for Harmonization (ICH), International Coalition of Medicines Regulatory Authorities (ICMRA), International Pharmaceutical Regulators Programme (IPRP), as well as in PubMed database and in grey literature. Global harmonization in the criteria for quality, safety and efficacy are promoted intensively through the ICH, ICMRA and IPRP initiatives since 1995. EMA was established in 1995 aiming to centralize drug authorization in Europe. EMA/ US FDA collaboration formally started in 2003 in various areas such as mutual recognition agreement on pharmaceutical inspections on good manufacturing practices, parallel EMA/FDA scientific advice or FDA/EMA patient engagement cluster. Most recently EMA and US FDA collaborated on a common scientific approach for advanced therapies to facilitate their development, on streamlining scientific requirements for hybrids applications, and on real-world evidence methodologies to optimize use to support regulatory decision-making. Both Agencies are considering also the initiation of pilot program in the field of oncology for medicinal products eligible for breakthrough therapy program (FDA) and the priority medicines scheme (EMA). ACSS Consortium (Australia, Canada, Singapore and Switzerland) recently initiated a joint assessment procedure for new chemical entities applications by Health Canada and TGA; however, marketing authorization is still remaining country-specific decision. Several transnational collaboration are seen among drug regulatory agencies Such collaborations are growing, including also HTA bodies, while more and more innovative products are launched and complex decisions to be made by decision-makers to ensure fast patient access.