8. What EMA publishes and when

What EMA publishes and when

EMA publishes information on medicines at various stages of their lifecycles, from early development through initial evaluation to post-authorisation changes, safety reviews and withdrawals of authorisation. The EMA Guide to information on human medicines (EMA/25370/2019 Page 2/30) describes the different types of information the EMA publishes (status 2021) for both centrally and non-centrally authorised medicines, as well as publication times and location on EMA’s website. It provides descriptions of the documents published and the regulatory context of publishing related to the lifeycle of a medicine.

The list shown below, adapted from the Guide provides its content:

1. Introduction
2. Applications for centralised marketing authorisation

2.1. Medicines under initial evaluation
2.2. Positive opinions
2.3. Negative opinions
2.4. Re-examination of opinions
2.5. Withdrawal of initial marketing authorisation applications

3. Changes to centralised marketing authorisations

3.1. Extensions of indication
3.2. Other variations, annual re-assessments, renewals and line extensions

4. Withdrawal/expiry of centralised marketing authorisations

5. EU referrals

5.1. Article 20, 31 and 107i referrals
5.2. Article 13(2), 29(4) and 30 referrals
5.3. Article 5(3) opinions
5.4. Article 29 (Paediatrics) opinions

6. Other documents and procedures

6.1. Orphan designations
6.2. ATMP classification
6.3. Requests for PRIME eligibility
6.4. Paediatric investigation plans
6.5. Safety signals
6.6. Medicines under additional monitoring
6.7. Compassionate use
6.8. Shortages
6.9. Periodic safety update reports
6.10. Imposed non-interventional post-authorisation safety studies
6.11. Direct healthcare professional communications (DHPCs)
6.12. Medicines for use outside the EU (Article 58)
6.13. Ancillary medicinal substances
6.14. Agendas, minutes and reports of meetings of EMA’s scientific committees
6.15. Medical literature monitoring

7. Information on non-centrally authorised medicines

8. Coordination of information on medicines

Annex: Tabulated overview of EMA documents on human medicinal products.

https://www.ema.europa.eu/en/human-medicines-regulatory-information

https://www.ema.europa.eu/en/medicines/what-we-publish-medicines-when-0#human-medicines-section

Guide to information on human medicines evaluated by EMA: https://www.ema.europa.eu/en/documents/other/guide-information-human-medicines-evaluated-european-medicines-agency-what-agency-publishes-when_en.pdf