Updated: FDA and EMA Progressing Toward Mutual Recognition of GMP Inspections

Regulatory NewsRegulatory News | 29 June 2016 |  By 

The US Food and Drug Administration (FDA) and European Medicines Agency (EMA) are making significant progress toward mutually recognizing each other’s good manufacturing practice (GMP) pharmaceutical inspections.

The news of the progress comes as both agencies continue to observe their counterparts’ inspections on an ongoing basis.

Emer Cooke, head of international affairs at the EMA, told Focus in an exclusive interview that both sides have “progressed quicker than we’d expected.” 

"FDA observed one audit in 2014 in Sweden, one in Greece in March 2015, one in Germany in May 2015, one in Croatia in June 2015, one in the UK and one in the Czech Republic in November 2015, one in Italy and one in Hungary in November 2015," EMA spokeswoman Marie-Agnes Heine told Focus. "Six additional audits are planned for 2016 (Austria, Estonia, Lithuania, Malta, Romania, Spain), all of which will be observed by FDA. Audits of 12 additional EU countries are planned for 2017." 

Currently, EMA has such mutual recognition agreements in place with Switzerland, Australia, New Zealand, Japan, Canada (with some limitations) and Israel (with some exclusions).

A major issue for both FDA and EMA is the question of trade secret information (inspections typically involve specifications of manufacturing equipment and processes for manufacturing drugs that are proprietary information), though Cooke noted that there is a provision in the Food and Drug Administration Safety and Innovation Act (FDASIA) from 2012 to allow FDA to share trade secrets with other regulators and she said FDA “has just internally clarified those conditions,” which is a positive step for moving forward.

As far as a timeline for when mutual recognition between US and EU regulators will begin, Cooke said she could not predict when it will be finalized as there are still some “legal hurdles that need to be resolved before we can be clear on timeframes. Compared with where we were, we’re moving far forward.”


The progress on mutually recognized inspections between the US and EU comes as an even more collaborative effort is underway at the international level for pharmaceutical regulation.

The relatively new International Coalition of Medicines Regulatory Authorities (ICMRA) is bringing together regulators from 22 countries, and the WHO as an observer, spanning across North America, South America, Europe, Asia and Africa.


And unlike the International Council on Harmonisation (ICH), which works on a more operational level, Cooke explained to Focus that ICMRA is designed to look more in a strategic direction. Currently, the group is focused on three priorities: the ever-expanding pharmaceutical supply chain, crisis management at the international level (ie. Ebola, Zika outbreaks) and pharmacovigilance.

Jonathan Mogford of the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) is acting as the ICMRA project lead on GMP inspections and supply chain issues, and he told attendees at DIA’s annual conference on Tuesday that the project has so far been practical, with “initial work on vision and principles, and how regulators can share and rely on inspection results for their own priorities.”

He said the framework has so far been tested by small number of countries, including Australia, Brazil, Canada, Ireland and the UK, and the second phase of that framework will involve discussions with more operational groups, notably PIC/S. He also mentioned that there have been discussions on combining the various track and trace systems around the world.

John Skerritt of Australia’s Therapeutic Goods Administration is leading the pharmacovigilance work for ICMRA and he said the group is trying to leverage big data on adverse event reporting. Pilot projects are planned for 2017.

And Jarbas Barbosa, director and president of Brazil’s ANVISA, is heading up the crisis management work of ICMRA, and said he will focus on not only on global pandemics alongside the WHO but on medicines shortages that have transcended borders.

Editor's Note: This story was updated on 7/1/16 with more specific information on the inspections observed by FDA in the EU, as provided by the EMA.


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