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The guidance answers questions on changes made to the regulatory framework to address challenges during the COVID-19 pandemic.
The European Medicines Agency (EMA) announced on April 10, 2020 that EMA, the European Commission, and the European medicines regulatory network have published a guidance document to provide stakeholders with information on how the regulatory framework has been adapted to address challenges during the COVID-19 pandemic. The Q&A document explains where regulatory flexibility is available to address constraints stakeholders may face during the pandemic.
Covered in the document are regulatory procedures for marketing authorizations, manufacturing and importing of APIs and finish products, quality variations, and labeling and packaging requirements. Some of the regulatory adaptations are for medicines specifically for COVID-19 patients.
EMA will be updating the document as necessary.