EU Regulatory Round-Up: COVID-19 Continuity, Ibuprofen Warnings, Nitrosamines, Ranitidine
Executive Summary
The latest EU OTC regulatory news: the EMA with EC and NCAs publish COVID-19 Business Continuity Plan; the CMDh decides to implement the PRAC's recommendations for ibuprofen and ketoprofen; the EMA and HMAs learn lessons from N-nitrosamine impurities in sartans; and the CHMP revisits its opinion on ranitidine following a request by a manufacturer.
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Council of Europe Directorate EDQM finds popular paracetamol products sold in the Netherlands and manufactured in China do not contain unsafe levels of a possible human carcinogen as reported in the Dutch media.
EMA Committee Warns Ibuprofen Can Seriously Exacerbate Infections
EMA's Pharmacovigilance Risk Assessment Committee wants ibuprofen and ketoprofen products to carry new warnings related to the risk of exacerbating serious infections.
EMA Advocates Suspension Of All Ranitidine Drugs In EU
Concerns over the presence of a probable human carcinogen will likely see marketing of all ranitidine-containing drugs suspended across the European Union.