The Chinese Chamber of Commerce for Import & Export of Medicines & Health Products (CCCMHPIE) has signed a strategic co-operation contract with blue inspection body, the German Good Manufacturing Practices (GMP) third party auditor, to maintain drug quality.

The alliance is designed to enable Chinese drug and active pharmaceutical ingredients (APIs) manufacturers to frame their quality management system (QMS) in compliance with the European GMP regulations.

Go deeper with GlobalData

Premium Insights

The gold standard of business intelligence.

Find out more

blue inspection body managing director Dr Stefan Kettelhoit said that the initiative is expected to strengthen the global pharmaceutical supply chain.

"About 80% of the APIs, currently used for drug products in the European Union, are already nowadays sourced from China and other Non-EU-Member states. The related product quality is in the vast majority of cases excellent," Kettelhoit said.

Under the deal, GMP auditors from blue inspection body will introduce Chinese organisations to the specifics of the EU GMP regulations and differences to the China Food and Drug Administration (CFDA) standards.

See Also:

Subsequent to a certification from the competent health authority, companies exporting APIs from countries such as China into the European Union are, from July, required to submit a written confirmation along with product deliveries.

How well do you really know your competitors?

Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.

Company Profile – free sample

Thank you!

Your download email will arrive shortly

Not ready to buy yet? Download a free sample

We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form

By GlobalData
Visit our Privacy Policy for more information about our services, how we may use, process and share your personal data, including information of your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address.

Mock audits will also be conducted by blue inspection body at CCCMHPIE’s member companies to allow the manufacturers to assess the extent of QMS compliance with the EU GMP regulations and make necessary adjustments.