US and EU Fully Implement Mutual Agreement on GMP Inspections

Regulatory NewsRegulatory News
| 12 July 2019 | By Zachary Brennan 

The US Food and Drug Administration (FDA) and European Medicines Agency (EMA) on Friday said they have now fully implemented a plan that will allow member state regulators and FDA to mutually rely on each other’s good manufacturing practice (GMP) inspections of drug facilities.

In addition to helping reduce redundancies in manufacturing inspections, the implementation of the Mutual Recognition Agreement (MRA) means that beginning Friday, pharmaceutical companies can stop import testing for products manufactured in the US.

The EMA and European Commission (EC) said in a Q&A that qualified persons in EU member states “will be relieved of their responsibility for carrying out the controls on human medicines laid down in Article 51 paragraph 1 of Directive 2001/83/EC provided that they verified that the product was manufactured in the United States and the controls have been carried out in the United States.”

The GMP Sectoral Annex to the MRA also discusses the batch testing further.

“Each batch/lot should be accompanied by a batch certificate (in alignment with the WHO certification scheme on the quality of medicinal products) issued by the manufacturer certifying that the product complies with requirements of the marketing authorization and signed by the person responsible for releasing the batch/lot,” the Q&A says.

MRA implementation work will also seek to expand the operational scope of the agreement to include veterinary medicines, human vaccines and human plasma-derived products, EMA said. FDA also said there is an option for regulators in the US and EU to rely on inspection reports for manufacturing facilities located outside each other’s territories.

The addition of Slovakia on Friday caps a years-long process of FDA confirming the capabilities of the 28 member states:
  • 1 November 2017: Austria, Croatia, France, Italy, Malta, Spain, Sweden and UK;
  • 1 March 2018: Czech Republic, Greece, Hungary and Romania;
  • 1 June 2018: Ireland and Lithuania;
  • 14 September 2018: Portugal;
  • 16 November 2018: Belgium, Denmark, Finland and Latvia;
  • 28 November 2018: Estonia;
  • 7 February: Poland and Slovenia;
  • 29 April: Bulgaria and Cyprus;
  • 10 June: Luxembourg and the Netherlands;
  • 26 June: Germany;
  • 11 July: Slovakia.
In June 2017, the European Commission (EC) found that FDA has the capability, capacity and procedures in place to carry out GMP inspections at a level equivalent to the EU.

“We welcome the implementation of this agreement, which means authorities on both sides of the Atlantic will now be able to rely on each other’s inspection results. This milestone is a testimony to the importance of our strategic partnership with the US. It will support making best use of our inspection capacity, so that patients can rely on the quality, safety and efficacy of all medicines, no matter where they have been manufactured,” said EMA Executive Director Guido Rasi.


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