EMA soon to publish updated guidance on Nitrosamine Impurities

2024-01-15T11:29:37+00:00July 20th, 2020|

EMA soon to publish updated guidance on Nitrosamine Impurities The EMA’s human medicines committee (CHMP) has now issued an opinion regarding the maximum limits of  nitrosamines in medicines and the measures required by pharmaceutical companies to reduce the presence of these carcinogenic impurities. As captured in our 2019 posts regarding nitrosamines and the considerations [...]

Nitrosamines: Considerations for Marketing Authorisation Holders

2024-01-15T09:49:34+00:00December 19th, 2019|

Nitrosamines: Considerations for Marketing Authorisation Holders Following a press release from the EMA on 26 Sep 2019, all marketing authorisation holders (MAHs) for human medicines containing chemically synthesised active substances must review their products for the possible presence of the carcinogenic class of compounds called nitrosamines. But where [...]

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