Addressing the Quality Issue

China’s National Medical Products Administration held discussions with the European Commission’s Directorate-General for Health and Food Safety (DG SANTE), the European Medicines Agency (EMA) and several other organizations to identify areas for improving the quality and manufacture of APIs. In recent years, there has been an increase in the number of problems stemming from the quality of APIs, resulting in shortages of some drug products in Europe. The majority of APIs that enter the EU are manufactured in India and China, but these countries do not meet the requirements of the European Commission’s equivalence assessments that determine whether manufacturing procedures employed ensure public health at the same standards observed in the EU. Instead, the API must be accompanied by a written confirmation issued by the competent authority of the country of origin that states the API has been produced according to EU equivalent standards of GMP.

However, the efficiency of this system has been called into question in recent years with a number of high profile incidents. One of the most recent is the ongoing global investigation into nitrosamine impurities in Valsartan, a high blood pressure medication. International regulatory authorities issued a recall due to contamination of APIs sourced from the two Asian nations.

The Commission explained that DG SANTE is taking steps to identify areas for improvement for countries who do meet the standards of the European assessment. DG SANTE has also contacted the FDA to develop a joint training plan for Indian and Chinese inspectors involved in the inspections of API manufacturing sites. Japan and WHO also expressed interest in being involved in the project.