FDA and EMA intensify international cooperation on ATMPs and Orphan Drugs

Tue, 2020 / 06 / 30
A virtual regulatory dialogue meeting between the European Commission, the EMA and the FDA took place on June 18th and 19th, 2020 in order to further strengthen the international cooperation for pharmaceuticals in the future. The participants examined existing joint initiatives, identified strategic milestones for the upcoming years, and attributed top priority to tackling the global COVID-19 crisis.

The topic of a worldwide regulatory cooperation in the approval and supervision of medicinal innovations is becoming increasingly important in terms of protecting public health and allowing patients timely access to new pharmaceuticals internationally. In this context, the EMA and FDA are already working together on an almost daily basis in around 30 different working groups, the so-called "clusters". In addition, the European Commission, the EMA and the FDA have been cooperating for several years as part of the ICMRA (International Coalition of Medicines Regulatory Authorities), which was established in 2012. The ICMRA unites the regulatory authorities for medicinal products worldwide to address and harmonize current as well as emerging regulatory and security challenges for novel human medicines on a global and strategic level transparently, continuously and in an institutional framework. Due to the COVID-19 pandemic, the international collaboration under the umbrella of the ICMRA has already been intensified considerably in the past few months in order to standardize the regulatory supervision for human medicinal products and in particular for new COVID-19 active substances.

In the recent bilateral dialogue, regulatory authorities discussed the following key points:

  • Current challenges in the clinical development, regulatory assessment and international availability of COVID-19 vaccines.
  • Perspectives of international cooperation on individualized therapies for very rare diseases (especially for gene therapies / ATMPs) in order to jointly address the scientific and regulatory challenges.
  • The support of multinational initiatives for data analysis to uniformly characterize Orphan Drugs and pediatric drugs.
  • Furthermore, the inclusion of real-world evidence from various data sources for regulatory decisions on the approval of medicinal innovations was debated. The research and development of COVID-19 active substances is supposed to serve as a precedent for generating coordinated measures on the control of vaccines, the identification of international cohorts and the use of pharmaceuticals in pregnant women with COVID-19. Beyond, an agreement was reached regarding the elaboration of an international roadmap on real-world evidence.
  • In July 2019, the complete implementation of the Mutual Recognition Agreement (MRA) for inspections and conformity assessments according to Good Manufacturing Practice (GMP) was achieved for certain human medicinal products. In the bilateral dialogue, the participants discussed extending the MRA to veterinary medicinal products, vaccines and plasma products by July 2022.


About the author

Ihre Ansprechpartnerin M.A. Strategic Management Nina Rüdemann
M.A. Strategic Management Nina Rüdemann
Fon: +49 511 64 68 14 0 – 0
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