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Business & Regulation Small Molecules, Standards & Regulation

Addressing the Quality Issue

This article was published in our sister publication, The Small Molecule Manufacturer, which celebrates the field of small molecule drug development and manufacturing with interviews and articles focusing on success stories, equipment, and new processing techniques.

Read more about The Small Molecule Manufacturer here

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.

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  1. European Commission, “ Note to the Pharmaceutical Committee updating on the actions undertaken with regard to the quality of Active Pharmaceutical Ingredients (API)”. 2019. Available at: http://bit.ly/3atqbsl.

About the Author

Maryam Mahdi

Associate Editor

After finishing my degree, I envisioned a career in science communications. However, life took an unexpected turn and I ended up teaching abroad. Though the experience was amazing and I learned a great deal from it, I jumped at the opportunity to work for Texere. I'm excited to see where this new journey takes me!

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