EU and China regulators meet to harmonize manufacturing standards

By Ben Hargreaves

- Last updated on GMT

(Image: Getty/Oleksii Liskonih)
(Image: Getty/Oleksii Liskonih)

Related tags China European union Ema Fda Harmonization

Representatives from the EMA and China’s NMPA convene to share expertise on GMP for APIs, GCP standards, and on the environmental impact of manufacturing.

The meeting took place on Friday of last week, with the European Medicines Agency (EMA) stating it was within the context of ongoing discussions between the European regulator and the Chinese National Medical Product Administration (NMPA).

In the EMA’s release​, the agency noted that China is one of the main suppliers of active pharmaceutical ingredients (APIs) to the European market and that discussions were based around finding a ‘common training curriculum’ for good manufacturing practice (GMP) and good clinical practice (GCP) standards.

In addition, the EMA outlined that it “introduced the Chinese delegation to EMA’s role and activities in areas like inspection coordination, the evaluation and authorization of medicines, and safety monitoring.”

The discussions between the two regulators is part of a joint European Union (EU)-China​ consultation process that was established in 2010 to share information regarding pharmaceuticals, medical devices, cosmetics and regulatory science.

Increased dialogue between regulators is part of a wider movement towards global harmonization of regulatory standards.

This year saw the conclusion of a multi-year project​ for the US Food and Drug Administration (FDA) and the EMA to recognize their respective regulatory inspections of facilities, thereby reducing the time and resources necessary to ensure GMP globally.

Such moves are part of a growing trend towards closer cooperation between global regulatory agencies, which has seen the EU and Japan​ extend mutual recognition agreements, as well as the FDA and Ireland​.

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