US and EU Talk Inspections, Generics, and Advanced Therapies at Bilateral Meeting

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FDA, EMA, and senior officials from the European Commission met to discuss the EU-US mutual recognition agreement for inspections, the development of advanced therapies, the requirements for approving generic drugs, and Real-World Evidence used for post-authorization monitoring.

The European Medicines Agency (EMA), senior officials from the European Commission, and FDA held a bilateral meeting in Brussels, Belgium on June 18-19, 2018 to discuss ongoing cooperative initiatives and strategize future collaboration. The meeting is part of the European and US partnership to collaborate regulatory efforts.

At the June meeting, the agencies discussed the progress of the EU–US mutual recognition agreement (MRA) on GMP inspections. The agencies committed to continue to work together to streamline the process. EMA stated in a press release that plans for the MRA to be operational in all EU Member States is on track for July 15, 2019.

Support for the development of advanced therapies (ATMPs), including gene and cell therapies, was agreed upon by the agencies. “The parties therefore agreed to encourage early parallel scientific advice and to further strengthen the existing ‘cluster’ on ATMPs with a view to develop common scientific approaches on the regulation of these medicines, that could best facilitate their preclinical and clinical development, and the way data collection on these medicines can be optimized after authorization,” EMA stated.

The agencies also discussed streamlining the approval of generic and hybrid drugs, especially complex generics and hybrids. EMA stated that understanding the legal, regulatory, and scientific requirements was important to both sides. “Options for next steps included the continued access for companies to EMA-FDA parallel scientific advice and further collaboration between regulators on the product-specific guidelines they develop.”


The agencies also agreed to collaborate on Real-World Evidence (RWE) for post-authorization monitoring of medicines to take advantage of each other’s expertise, experience, and data. EMA and FDA will exchange information and work together on methodologies to optimize use of RWE.

“The EC/EMA and FDA will continue their strong cooperation in numerous activities under their responsibilities, including innovation. 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,” EMA stated.

Source: EMA