EMA-FDA: Agencies Want to Strengthen Collaboration

Regulatory NewsRegulatory News
| 22 June 2018 | By Michael Mezher 

The European Medicines Agency (EMA) on Friday gave an update on the current and future status of its ongoing collaboration with the US Food and Drug Administration (FDA). 

The two agencies have a long history of cooperation in a number of areas, including offering parallel scientific advice to drugmakers, and have collaborated on good clinical practice (GCP) inspections, quality by design and simplifying administrative barriers to improve cross-agency communication. 

Most recently, EMA and FDA signed a landmark agreement to mutually recognize good manufacturing practice (GMP) inspections between participating national competent authorities and FDA, which has now expanded to 14 EU member states

The update comes after the agencies' annual bilateral meeting that took place in Brussels earlier this week. 

"The two-day bilateral regulatory dialogue allowed the strategic partners to review their ongoing cooperative initiatives, discuss strategic priorities for the coming years and further strengthen the continuous close collaboration with specific action in the field of pharmaceuticals," EMA said. 

During the meeting, EMA said that the two regulators discussed measures to improve the mutual recognition agreement for GMP inspections. 

Efforts are currently underway to expand the agreement to all EU member states by 15 July 2019, and the two agencies said they plan to work more closely on a technical level going forward. The regulators also reiterated their intent to include inspections for veterinary medicines and plasma-derived products in the agreement by July 2019 and July 2022, respectively. 

EMA and FDA also agreed to encourage parallel scientific review for advanced therapies, such as cell and gene therapies and tissue engineered products, to support a common approach to development and postmarket data collection. 

Additionally, the two agencies discussed how to streamline the review and approval of generic drugs, focusing on complex generic drugs in the US and hybrid generics in the EU. 

However, EMA noted that planned cooperative activities will need to take into account disruptions due to its preparations for Brexit and upcoming relocation to Amsterdam. 



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