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Regulatory Focus™ > News Articles > 2020 > 1 > EU-China Working Group to Address API Manufacturing Concerns

EU-China Working Group to Address API Manufacturing Concerns

Posted 13 January 2020 | By Zachary Brennan 

EU-China Working Group to Address API Manufacturing Concerns

As active pharmaceutical ingredient (API) quality concerns linger, China’s National Medical Products Administration (NMPA) has agreed to work with the European Commission’s DG Sante, the European Medicines Agency (EMA) and others to identify similarities and differences between the Chinese and EU regulatory systems for APIs.

The commission says it has created a budget to conduct a gap analysis, which would be used to identify Chinese training needs in the API space. EU experts will also conduct a fact-finding visit to China to assess the regulatory, control and enforcement system governing the implementation of GMP standards, according to the agreement forged at a bilateral EU/China meeting in October 2019.

The announcement of the gap analysis came as part of the documents released in the 85th meeting of the commission’s Pharmaceutical Committee last month, and they were released as the commission is considering whether its written confirmation system can guarantee that imported APIs are manufactured in accordance with GMPs.

The commission also says it contacted the US Food and Drug Administration (FDA) for a project on a joint training plan for Indian and Chinese inspectors of APIs manufacturing sites. Japan’s regulators and the World Health Organization (WHO) also expressed interest, and information on recent inspection trainings in China and India were requested by EMA, FDA, Japan and WHO. EMA is also collecting information on scheduled training events for 2020 through 2022.

Meanwhile, William Sutton, FDA’s assistant country director in China and a 36-year veteran of FDA, announced that he will retire from federal service in August.

Over the longer term, the European Commission is also exploring the capacity for European API production as recent quality incidents involving APIs sourced from China and India (i.e., nitrosamine contamination of valsartan and ranitidine) raised questions about sustainability.

“The nitrosamine contamination crisis confirmed the importance of the cooperation on the quality standards for medicines with the Council of Europe,” the commission says. “DG Sante plans to continue to cooperate with EDQM [European Directorate for the Quality of Medicines and HealHealthCare] for incidents or crisis situations.”

The commission also says it’s looking to help align other non-EU countries with EU standards and to assess their GMP systems. “In the long run, this could eventually lead to the listing of these countries as equivalent,” the commission says.

Meanwhile, the commission also is finalizing its evaluation of the orphan and pediatric regulations.

Note to the Pharmaceutical Committee updating on the actions undertaken with regard to the quality of Active Pharmaceutical Ingredients (API)

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