News about GMP/cGMP

01.02.2019

US-EU Trade Agreement: News for the GMP sector

The Executive Working Group, EWG has published an interim report on the current status of its work. The focus is on the development of short- and medium-term practicable solutions in regulatory matters. In the area of pharmaceuticals and medical devices, the following approaches are being pursued or further pursued:

  • The existing MRA (Mutual Recognition Agreement) is to be extended to veterinary medicinal products. A detailed action plan should be available by July 2019.
  • By 2022, the MRA shall also be extended to joint inspections of production facilities for human vaccines and plasma derivatives. The starting signal is to be given in 2019.

The goal is to further minimize duplication. The already existing MRA, for example, contributes on average to a cost saving of 380,000 US$ per inspection and additionally frees up important resources for the authorities.

  • In the area of medical devices, the USA and the EU plan to take measures to ensure compatibility of the database specifications for UDIs (Unique Device Identifiers). Such a UDI system already exists in the USA and is currently being introduced in the EU.

This cooperative work is in line with the ongoing efforts of the International Medical Device Regulators Forum (IMDRF), which in 2018 developed a guide to help regulators develop their UDI systems in a globally harmonised way.

  • Individual audit reports should also be included as part of the MDSAP programme (Medical Devices Single Audit Programme).

Australia, Brazil, Canada, Japan and the USA are already participating in the MDSAP. Canada announced its participation in the MDSAP in early January. MDSAP enables recognized audit firms to conduct a single audit of a medical device manufacturer that meets the requirements of multiple regulatory agencies for Quality Management Systems (QMS) and Good Manufacturing Practices (GMP).


Source:

EU-US Relations: Interim Report



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