Some China API Firms Wont Have 'Written Confirmations' by July says blue inspection body

By Gareth Macdonald

- Last updated on GMT

Related tags: Blue inspection body, European union

Some China API Firms Wont Have 'Written Confirmations' by July says blue inspection body
Some China API Firms Wont Have 'Written Confirmations' by July says blue inspection body
Some Chinese firms wont have the 'written confirmations' required to ship APIs to the EU from July according to the German audit firm tasked with helping manufacturers prepare by Beijing industry group, CCCMHPIE.

The China Chamber of Commerce for Import & Export of Medicines & Health Products (CCCMHPIE) announced that it had called on Germany’s blue inspection body to explain the specifics of the new EU GMP rules​ and how they differ from local standards to its 2,400 members earlier this month.

blue inspection body managing director Stefan Kettelhoit told in-Pharmatechnologist.com the idea is to increase the overall quality understanding and explain how Chinese manufacturers should implement quality systems that meet with EU and international GMP requirements.

Kettelhoit added that although CCCMHPIE members will not be obliged to seek audits by blue inspection body, the organisation expects that manufacturing facility inspections will be an important part of the agreement.

In the past we have seen an increase in such audits initiated by the manufacturers in order to prepare for upcoming regulatory inspections or even just to show their quality level to their customers​.”

From July all APIs shipped to the European Union will need to be accompanied by written confirmation of manufacturing quality issued by national regulators unless they are produced in countries where standards that have been deemed equivalent to those in Europe​.

This requirement has been a subject of considerable concern among drugmakers and regulators in Europe worried that authorities in key API source countries – primarily China and India – were not doing enough to make sure manufacturers comply with the EU rules.

In March​, for example, the UK MHRA warned of potential drug shortages on the basis that APIs shipped without the appropriate documentation will not be allowed into the EU.

Similarly, drug industry group EFPIA​ called on the European Commission to do more to engage with regulators in China and India before the new laws come into force.

With this in mind we asked Kettelhoit for his take on this situation and the news is mixed.  

According to what we have heard​,” he told us “the Chinese government will in the first instance only issue written confirmations for manufacturers, which have been C-FDA inspected and/or at least also EU GMP inspected.

This means, that certain Chinese manufacturers will not be able to obtain a written confirmation​.” On a more positive note Kettelhoit added that: “The knowledge about the written confirmation is available and quite well distributed in China since quite a while, as we could already testify during last year’s CPhI China.”

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