EMA: Concept Paper on Active Substances and Nitrosamine Impurities

On 26 July 2022, the EMA published a concept paper to start the process for the revision of the Guideline on the chemistry of active substances. The document dates from 2016 and does not consider the nitrosamine issue that has developed in recent years.

The critical need to revise and update this important guideline was identified when the "Lessons learnt report" on impurities in sartan medicines was compiled.

What can be expected in terms of content?
Recommendations for the prevention, risk reduction and control of N-nitrosamines, but also for other "contaminants of concern" (CoC) and potent toxins will be included. Also to be tackled are

• Strategies for process development
• The subject areas of raw materials, starting materials and intermediate products and their potential contamination risk
• The use of recycled materials
• Specific control options for nitrosamines

The EMA Quality Working Party (QWP) has appointed two rapporteurs as well as experts from different Member States with expertise in this field to the drafting group. The group will be supported by an observer from the European Directorate for Quality of Medicines (EDQM), who will work closely with the QWP expert group on nitrosamines.

What is the schedule?

The concept paper will be available for comments until 31 October 2022. Following this, a draft document will be prepared, which will then be released for comments for six months.

Source:

EMA: Concept Paper on the revision of the guideline on the chemistry of active substances
EMA: Guideline on the chemistry of active substances