EU, Japan to Share More Information on GMP Inspections

Regulatory NewsRegulatory News | 05 October 2016 |  By 

The European Directorate for the Quality of Medicines and Healthcare (EDQM) this week announced a new agreement with Japanese authorities to share more information on the outcome of good manufacturing practice (GMP) inspections of manufacturing sites of active pharmaceutical ingredients (APIs) of interest to both Europe and Japan.

The agreement follows the exchange of letters on 13 September 2016 in which Japan’s Pharmaceutical Safety and Environmental Health Bureau of the Ministry of Health, Labour and Welfare (MHLW), the Pharmaceuticals and Medical Devices Agency (PMDA) of Japan and the EDQM explain how communications will be improved while respecting the confidentiality of nonpublic information.

Both regulators began sharing such inspection data back in 2013, though mutual recognition agreements date back to 2003. And back in 2012, the European Fine Chemical Group, an industry association of API manufacturers, called for mandatory inspections of all API manufacturing sites through the use of mutual recognition agreements.

The EU and US, meanwhile, are still working on ways they can mutually recognize each other’s GMP inspections.

Emer Cooke, former head of international affairs at the EMA, told Focus in June 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." 

A major issue for the sharing of any nonpublic information is the question of trade secret information (inspections typically involve specifications of manufacturing equipment and processes for manufacturing drugs that are proprietary information), though 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.

Pharmacopeia Collaboration

In addition, the EDQM and MHLW signed a 5-year memorandum of cooperation defining measures to strengthen the collaboration between the European and Japanese pharmacopoeias.
These include the option of organizing bilateral meetings, workshops and internships between the two and various Japanese regulatory bodies in order to share experiences and information on the development of monographs and methods of testing. To this end, the EDQM and MHLW also agreed to set up an ad hoc Technical Working Group with staff members of the EDQM and Japanese regulatory bodies and relevant experts.

EDQM enhances sharing of information with Japanese regulatory authorities and strengthens collaboration with Japanese Pharmacopoeia


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