Quick Notes:
*Within the report the “conditional marketing authorisations” and “monitoring in real-life” are the “go to” section to see what the post-authorisation obligations were and what the EMA is looking for post-approval.
*Interesting info for competitors in the various therapy areas, this can help define their strategy going forwards, but also this is the kind of thing I see as being part of a trend analysis report (annual).
*Nothing COVID related from our perspective.
Quotes from Source:
1. “EMA has published an overview of its key recommendations in 2020 on the authorisation and safety monitoring of medicines for human use.”
2. “In 2020, EMA recommended 97 medicines for marketing authorisation.”
3. “The Agency recommended one vaccine and one treatment for COVID-19, and adopted a positive opinion for a medicine for use in countries outside the EU.”
4. “The infographic includes figures on the authorisation of medicines and a selection of new treatments that represent significant progress in their therapeutic areas.”
5. “Once a medicine is authorised by the European Commission and prescribed to patients, EMA and the EU Member States continuously monitor its quality and benefit-risk balance and take regulatory action when needed.“
Source URL: https://www.ema.europa.eu/en/news/human-medicines-highlights-2020