🇪🇺 EMA Q&A Rev. 18 EMA/409815/2020 - Deadlines


Thank you for sharing the information, @Sarada.jena.

The updates in “Q3. For the ‘call for review’ for chemically synthesised and biological medicinal products, when and how should MAHs report steps 1 and 2 to competent authorities?” are as follows;

Please note the set deadlines of the Call For Review (Step 1, 2 and 3) as described above for medicines containing chemically synthesised and biological active substances have passed.

Any MAHs that have not reported identified Nitrosamine impurities to the relevant Competent Authority, should do so as a matter of priority, including any updates to previous notifications. MAH(s) should report in accordance with the established limits and recommendations described in this guidance. MAH(s) should continue to use the response templates and available communication mechanisms previously established. MAH(s) are reminded of their responsibilities to ensure the quality, safety and efficacy of their medicines and to adhere to the Nitrosamines guidance outlined by the EU Network. MAHs and Manufacturers should work together and take precautionary measures to mitigate the risk of presence of nitrosamines during the manufacturing and storage of all authorised medicinal products and throughout the lifecycle of the product if any changes are made. Authorities in the EU will continue take all necessary measures to protect patients and ensure that medicines in the EU meet the required quality standards. The Authorities in the EU will also continue to collaborate with international partners on Nitrosamine to reflect scientific advances.

As the Step3 deadline for products containing chemically synthesised APIs(1st October 2023) has passed, the description of MAH’s responsibility was added.


Is this the beginning of the Nitrosamines Impurities regulatory scrutiny? I guess time will tell soon…

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