Spain – Spain Creates Guide to Sharing Information About Nitrosamine Testing

The Spanish Agency of Medicines and Medical Devices (AEMPS) has created a guide for companies affected by a request to test products for nitrosamines. AEMPS’ guide walks manufacturers through the steps they need to take, starting with analyses of the risk of their products being contaminated.

Faced with evidence that a rising number of drugs are contaminated with carcinogenic nitrosamine impurities such as N-nitrosodimethylamine, the European Medicines Agency (EMA) asked companies to assess whether their products are at risk late last year. This week, AEMPS followed up on EMA’s request by setting out what companies need to do to comply with the regulatory requirement.

The first step is to analyze the risk of nitrosamine contamination in finished products. AEMPS wants manufacturers to perform those analyses and report the results as soon as possible. The deadline for sharing the results is 27 March…