News about GMP/cGMP

26.02.2021

EMA: Update on recommendations for handling nitrosamines

On 22 February 2021, the European Medicines Agency (EMA) published a 14-page implementation plan dealing with the prevention of nitrosamine impurities. It is based on the results of the CHMP's scientific review of the subject.

The European Medicines Regulatory Network (EMRN) held a meeting on this and has now presented a harmonized implementation approach on the results:

European Medicines Regulatory Network approach for the implementation of the CHMP Opinion pursuant to Article 5(3) of Regulation (EC) No 726/2004 for nitrosamine impurities in human medicines.

In the process,the according Q&A was also revised

Questions and answers for marketing authorisation holders/applicants on the CHMP Opinion for the Article 5(3) of Regulation (EC) No 726/2004 referral on nitrosamine impurities in human medicinal products.

Questions 3, 4, 5, and 8 have been updated as the following templates have changed:

GMP Compliance Adviser

News about GMP/cGMP

EMA: Update on recommendations for handling nitrosamines