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In brief

On 18-19 June 2020, senior officials from the European Medicines Agency (EMA), the European Commission and the US Food and Drug Administration (FDA) held a meeting to review their ongoing joint initiatives, discuss strategic priorities for the coming years and identify areas where their collaboration could be strengthened.


In particular, the meeting focused on, among others, the following topics:

  • shared experiences and common challenges in facilitating the development, review and availability of COVID-19 vaccines
  • opportunities for cooperation on individualized/bespoke therapies for ultra-rare diseases
  • implementation of the Mutual Recognition Agreement of Good Manufacturing Practice inspections on medicines for human use and the possible application of the same agreement to veterinary medicines, vaccines and plasma-derived products and
  • exchange of information on orphan and paediatric medicine initiatives and possible cooperation in the area of data analysis for the characterization of rare diseases

In a press release, the EMA emphasized that, in the context of the COVID-19 pandemic, collaboration with the European Commission and the FDA, which started in 2003, has been further intensified, notably under the umbrella of the International Coalition of Medicines Regulatory Authorities (ICMRA).

Author

Roberto Cursano is a counsel in Baker Mckenzie since 2007 in Rome, Italy office. His practice focus more in pharmaceutical and healthcare law matters and compliance, and assists in tender procedures, the negotiation of public contracts and litigation before administrative courts.

Author

Riccardo Ovidi is an associate in Baker McKenzie's Rome office.

Author

Irene Carlet is a Law Clerk/Intern in Baker McKenzie's Rome office.