EMA: Revised Guideline on the Chemistry of Active Substances
The EMA published for consultation an update of the guideline on the chemistry of active substances. The need for revision was identified in the report on “Lessons learnt from presence of N-nitrosamine impurities in sartan medicines” (LLE), which makes recommendations to reduce the risk of N-nitrosamines being present in human medicines and to help the European medicines regulatory network to be better prepared to deal with future cases of unexpected impurities.
The revised guideline provides additional and more comprehensive guidance related to the following aspects:
- Identified risk factors for formation of N-nitrosamines and also other the ‘cohort of concern’ compounds (CoC compounds), if applicable.
- Strategies for avoiding or preventing as much as possible the formation and presence of N-nitrosamines specifically. Some of these strategies will also be relevant for other impurities such as the CoC compounds or other potent toxins more generally.
- Clarification on how the applicant should document and discuss the potential presence of these impurities in active substances in regulatory submissions.
Consultation start date: 25 July 2024
Consultation end date: 31 January 2025
Source:
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