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Sticking To Nitrosamine Evaluations Deadline Is Priority For EU Regulators

Industry's Request For A Standardized Approach Has Been Set Aside

 
• By Vibha Sharma

EU regulators say that sponsors must complete their nitrosamine-related risk evaluations for all EU medicines containing chemically-synthesised active substances within the six-month timeframe.

Nitrosodimethylamine
Industry Wants A Standardized Process For Nitrosamine Risk Evaluations • Source: Shutterstock

EU drug regulators have turned down industry’s request for a standardized process to help sponsors identify products that are at risk of possible nitrosamine contamination within the six-month deadline ending on 26 March 2020.

Regulators have said that they do not have the time or the resources to develop or validate a standardized process...

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