US and EU Sign Agreement to Mutually Recognize Drug Manufacturing Inspections

In 1998, the European Union (EU) and the US signed the Mutual Recognition Agreement (MRA) with provisions specifically about current Good Manufacturing Practices (cGMPs) for drugs but were unable to start implementation. Since 2014, both the US and European Medicines Agency (EMA) revived agreement talks concerning the cGMP provisions.

Starting in 2012 with the passage of the Food and Drug Administration Safety and Innovation Act, Congress granted the Food and Drug Administration (FDA) to create mutual agreements for drug inspections with foreign regulatory agencies.

After reviving talks in 2014, the FDA has been invited by the EMA to observe EU-based audits and inspections by other EU member states. In this case, the FDA witnessed an audit of Swedish inspections by British and Norwegian officials.

As global supply chains become more complex and more intertwined, regulatory bodies face new challenges associated with non-standardized international regulations that pose a risk in creating availability delays and elongating drug manufacturing cycles, which drive up costs.

The MRA now allows the EMA and FDA to recognize each other’s GMP inspections of pharmaceutical and active pharmaceutical ingredient (API) manufacturing facilities. The MRA will eliminate duplicate inspections, lower costs, and free up the agencies to focus their attention on other issues.

Unlike the US, where the FDA is the only overseer, each member state in the EU is free to exercise its standards if it meets the EMA’s requirements. The transition period is expected to extend until July 2019, and imported products must be batch tested until then. After that, batch testing is no longer required.

Recognition of inspections can start as early as November 2017 after the EU’s assessment of the FDA. The FDA is expected to complete its evaluation of eight EU member states by that deadline. From there, the FDA will ramp up efforts to expand to the other member states.

Once the MRA goes into effect, the scope includes:

  • Informational exchanges between the FDA and EU-based regulators
  • Trades of medicinal products and constituent ingredients
  • GMP inspections

Products currently covered include:

  • Clinical trial investigational products
  • Finished Pharmaceuticals and Dietary Supplements currently available on the market
  • Biologics such as vaccines, plasma derived pharmaceuticals, and more
  • In-process materials (US) and intermediates (EU)
  • APIs and bulk drug substances
  • Veterinary/animal products

The EMA has several mutual recognition agreements for GMPs in place with Switzerland, Australia, New Zealand, Japan, Canada, and Israel.

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