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News about GMP/cGMP

2016-10-07

EDQM: New Agreement with Japanese Health Authorities

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

 

On 13 September 2016, the 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 exchanged letters that detail how communication between the parties will be enhanced, at the same time respecting the confidentiality of information that is not in the public domain.

In addition, the EDQM and MHLW signed a 5-year Memorandum of Cooperation which defines concrete measures for strengthening collaboration between the European and Japanese Pharmacopoeias (Ph. Eur., JP). These include the option of organising bilateral meetings, workshops and internships between the Ph. Eur., the JP and various Japanese regulatory bodies in either region/country.  The purpose is 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 involving staff members of the EDQM and Japanese regulatory bodies as well as relevant experts.

 

Source:

EDQM: Newsroom

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