
EMA Publishes COVID-19 Q&A Guidance
The guidance answers questions on changes made to the regulatory framework to address challenges during the COVID-19 pandemic.
The European Medicines Agency (EMA)
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.
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