Europe – 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

On 10 September 2019, a referral according to Article 5(3) of Regulation (EC) No 726/2004 was triggered by the EMA Executive Director (ED) requesting the CHMP to conduct a scientific evaluation on the presence of nitrosamine impurities in human medicines containing chemically synthesised active pharmaceutical ingredients (APIs). The procedure was foreseen to run in a 2-step approach as follows:

• 1st phase, to provide considerations for marketing authorisation holders (MAHs) of these medicines on the identification of the possible presence of nitrosamine impurities;

• 2nd phase, taking into account ongoing work for the lessons learnt on the sartans review, to evaluate all available scientific knowledge on nitrosamine impurities in these medicines and their impact on the safe use of medicines, and to consider if the current scope should be broadened to other medicinal products. This evaluation will serve as a basis to achieve a coordinated approach and response across the EU and to advise regulatory authorities (RAs) on the actions to be taken following detection by MAHs of the presence of N-nitrosamine impurities in their medicines…