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 [...]

EMA Provide Advice on Regulatory Expectations and Flexibility during the COVID-19 Pandemic

2024-01-15T10:07:43+00:00April 14th, 2020|

EMA Provide Advice on Regulatory Expectations and Flexibility during the COVID-19 Pandemic In the wake of the on-going COVID-19 pandemic, the EMA has published a Question and Answers document which provides guidance to stakeholders on the implemented adaptations to regulatory framework that have been put in place to address some of the unprecedented challenges [...]

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