SFDA asks API makers for GMP certificates ahead of new EU import laws

By Gareth Macdonald

- Last updated on GMT

Related tags European union Active ingredient

SFDA to investigate API industry
SFDA to investigate API industry
Chinese API makers will have to tell the SFDA if they have a European GMP certificate as part of a wider industry investigation prompted by new EU import laws.

The SFDA announced its assessment of the bulk drug industry last week​ citing new laws that require active pharmaceutical ingredients (APIs) shipped to the EU are accompanied written confirmation of quality (directive 2011/62/EU​) as a prompt for the investigation.

According to the SFDA's statement (available here in Chinese​) active ingredient suppliers will have to display their GMP certificates and improve the English language versions of their websites.

Xinhua, the Chinese state media organisation, reported that API manufacturers will also have to share their names and license numbers with the agency as well as providing it with details of major export destinations.

China​ concerns

China is a major source of the APIs used in Europe and its importance in the supply chain has been a concern for those worried about the impact of the new EU import laws.

In October​ supply chain focused industry group RX360 warned that Chinese manufacturers may balk at the new ‘written confirmation requirements’ and switch their attention to other markets, potentially creating shortages in Europe.

Similarly in December​ the UK MHRA said it would  ‘reserve its position’ on the new import laws until they come into effect in July, citing uncertainty over the position of China and several other major supply countries on the new laws.

It told in-pharmatechnologist.com that: “The position with China, India, Japan and Mexico remains unclear. The [European] Commission discussions are ongoing with each​,” adding that “The UK may have to reserve its position in respect of active substances imported from third countries in order to ensure availability of medicinal products.”

Whether measures like the one launched by the SFDA or other like Indian plans to set up an API oversight body​ will be enough to make sure manufacturers comply with the laws and convince those with concerns remains to be seen.

The SFDA was not available for comment when contacted by in-pharmatechnologist.com.

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