International – 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…