Addressing concerns surrounding China’s API manufacturing quality

The European Commission (EC) and European Medicines Agency (EMA) will collaborate with China’s National Medical Products Administration (NMPA) to conduct a gap analysis on the Chinese and EU regulatory systems for active pharmaceutical ingredients (API).

The majority of APIs used for manufacturing medicinal products for the EU market come from India and China. API compliance with EU Good Manufacturing Practice (GMP) relies on written confirmations issued by the relevant competent authorities. Recent incidents involving the APIs sourced from China and India, such as the detection of nitrosamine impurities, have raised questions about the system of written confirmations. Does it provide sufficient guarantees that imported APIs are manufactured in accordance with GMP rules?

DG SANTE, the EU Directorate-General for Health and Food Safety, is taking action to rectify the shortcomings in the implementation and design of the system. These actions will focus on increasing the oversight on the GMP systems of China. They hope to achieve this by promoting China’s cooperation, encouraging them to align their regulatory framework with international standards and undergo a “fact-finding assessment”, assessing the regulatory, control and enforcement system governing their GMP standards. These steps could potentially lead to the listing of China as equivalent.

The proposed gap analysis will also allow identification of Chinese training needs in the API area. Furthermore, the US Food and Drug Administration (FDA) have been contacted regarding a joint training plan for Indian and Chinese inspectors of API manufacturing sites. Japan and the World Health Organization (WHO) have also expressed interest, potentially increasing the budget available for such critical training.

The availability of high quality APIs for manufacturing of medicinal products for the EU market is a growing concern. These manufacturing issues are one of the major reasons for the current shortages of medicinal products in the EU.

Find out more here.