US, EU pledge to cooperate on UDI specifications

30-01-2019

US, EU pledge to cooperate on UDI specifications

(Source: RAPS 2019-01-31)

The US and EU will cooperate to ensure alignment of electronic database specifications for Unique Device Identifiers (UDIs) and will develop a bilateral test of compatibility of respective UDI databases, according to the interim report on the work of the US-EU Executive Working Group (EWG) on trade.

The report said such cooperative work will be in concert with ongoing efforts from the International Medical Device Regulators Forum (IMDRF), which consulted on UDIs in 2018 and developed a guidance to help regulatory authorities develop their UDI systems in a globally harmonized way. The work is expected to better facilitate the identification and tracking of devices. Such a UDI system already exists in the US and is currently being introduced in the EU.

In addition to UDIs, the interim report says that the EU will also make use of single audit reports as part of IMDRF’s the Medical Devices Single Audit Programme (MDSAP). Currently, Australia, Brazil, Canada, Japan and the US are members of MDSAP, which became operational in 2017. Canada recently announced its transition to MDSAP, as participation in the program has increased.

MDSAP allows recognized auditing organizations to conduct a single audit of a device manufacturer that will satisfy the requirements of multiple regulatory jurisdictions for Quality Management Systems (QMS) and Good Manufacturing Practices (GMP) requirements.

Pharmaceuticals

The EWG report also noted that agreement has been reached in principle to expand the scope of the US- EU Pharmaceutical GMP Mutual Recognition Agreement (MRA) to include veterinary drugs. The EU-US deal began back in 2017 as a way to reduce unnecessarily duplicative GMP inspections.

“The two sides will work to identify a plan of actions and timetable to support an informed decision by July 2019. Both sides will also endeavor to start in 2019 joint inspections of manufacturing facilities for human vaccines and plasma-derived pharmaceuticals, paving the way for the potential extension of the MRA to these areas no later than 2022,” the report said.

The report also revealed that because of the existing MRA, the EU and US realize savings of $380,000 per average inspection, as well as ensuring an improved allocation of resources by regulators.

“Once the agreement is fully implemented, hundreds of inspections of pharmaceutical facilities could potentially be avoided thanks to the EU-US agreement,” the report noted.

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