EMA and FDA collaboration on medicines

The European Commission (EC), the European Medicines Agency (EMA) and the United States Food and Drug Administration (FDA) held their 2018 bilateral meeting in Brussels, Belgium on 18th and 19th June. The two-day meeting allowed the strategic partners to review their ongoing cooperative initiatives, discuss priorities for the coming years and further strengthen the continuous close collaboration in the field of pharmaceuticals.

The EMA and FDA formally started collaborating in 2003, and have gone from strength to strength. The two agencies have daily interactions, with the aim to advance scientific and regulatory excellence worldwide.

Some of the topics discussed at the 18th-19th June meeting included:

  • Advanced therapy medicinal products (ATMPs): Regulators on both sides of the Atlantic are actively supporting the development of these novel medicines, which include gene therapies and tissue engineered products, and are experiencing similar regulatory challenges. Therefore, the EMA and FDA have agreed to encourage early parallel scientific advice and to strengthen the existing ‘cluster’ on ATMPs. The aim is to develop common scientific approaches on the regulation of these medicines that could best facilitate their preclinical and clinical development, and how data collection on these medicines can be optimised after authorisation.
  • The European Union (EU)-United States (US) mutual recognition agreement on pharmaceutical inspections on good manufacturing practices (GMP) came into operation in November 2017. The EC, EMA and the FDA discussed the progress made and experience gathered in the implementation of the agreement, which currently covers 14 EU Member States. The EMA and FDA plan to continue working closely together to further streamline the process, measure progress and monitor the implementation; plans for the agreement to be operational in all EU Member States by 15th July 2019 are on track. The EMA and FDA also confirmed their intention to consider vaccines and plasma derived pharmaceuticals in the mutual recognition agreement, no later than July 2022.
  • Develop a better understanding of the fundamentals of legal, regulatory and scientific requirement for approving generic and hybrid applications on both sides, and to identify ways of streamlining the scientific requirements for such approvals with focus on complex generics (FDA) and hybrids (EU). Actions included continued access for companies to EMA-FDA parallel scientific advice and further collaboration between regulators on product-specific guidelines.
  • Real-World Evidence (RWE): For many years, RWE has been used for the post-authorisation monitoring of medicines, and the EC/EMA and FDA have agreed that RWE holds promise to strengthen decision-making on medicines throughout their lifespan. The EMA and FDA plan to frequently exchange information and work together on methodologies to optimise the use of RWE to support regulatory decision making throughout the product lifecycle.

The EC/EMA and FDA plan to continue their strong cooperation in numerous activities under their responsibilities, however the activities planned in the next couple of years will need to take into account EMA’s business continuity needs during and after its relocation to Amsterdam.

To read more about the reinforced EU/US collaboration on medicines, please click here.