This report highlights information about human medicines and comes from the EMA. In 2022, EMA recommended 89 medicines for marketing authorization. Of these, 41 had a new active substance which had never been authorized in the European Union before. The overview of the 2022 key recommendations published today includes figures on the authorization of medicines and a selection of new treatments that represent significant progress in their therapeutic areas.

Public health emergencies remained a key priority for EMA in 2022. The highlights document summarises the most important recommendations on vaccines and treatments for COVID-19 and for monkeypox.

Once a medicine is authorized 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. Measures can include a change to the product information, the suspension or withdrawal of a medicine, or a recall of a limited number of batches. An overview of some of the most notable safety-related recommendations is also included in the document.

Read more here.

References

  1. EMA. (2022). Human Medicines Highlights 2022. https://www.ema.europa.eu/en/documents/report/human-medicines-highlights-2022_en.pdf

Disclaimers

  • The material in these reviews is from various public open-access sources, meant for educational and informational purposes only
  • Any personal opinions expressed are those of only the author(s) and are not intended to represent the position of any organization(s)
  • No official support by any organization(s) has been provided or should be inferred