CHAPTER 2: KEY FIGURES IN 2025
Human medicines
In 2025, EMA’s work across the medicines lifecycle helped to guide innovative treatments to market that strengthen public health. The Agency supports developers at every stage of medicine development, helping to boost innovation and research by offering expertise before, during and after marketing authorisation.
Activities supporting research and development
Scientific advice received
During a medicine’s development, a developer can request guidance and direction from EMA on the best methods and study designs to generate robust information on how well a medicine works and how safe it is. This is known as scientific advice.
Scientific advice is one of the Agency’s key instruments for supporting the development of high-quality, effective and safe medicines, for the benefit of patients. Early dialogue and scientific advice lead to better development plans, promote the collection of high-quality data and, most importantly, help to ensure that patients only take part in those clinical trials that are likely to be robust enough to generate data that are relevant to support the evaluation of a marketing authorisation application or extension of indication.
In 2025, EMA received a total of 647 requests for scientific advice. Protocol assistance is the special form of scientific advice for developers of designated orphan medicines for rare diseases. The requests for protocol assistance amounted to 133 requests in 2025.
PRIority Medicines (PRIME) recommendations adopted by EMA
PRIME aims to support and optimise medicine development so that patients who have no or only unsatisfactory treatments for their disease have access to new medicines that have the potential to make a difference and enable them to live healthier lives. In 2025, EMA received 68 PRIME eligibility requests, 17 % more than in 2024, and adopted 56 recommendations. The Agency received 68 requests for scientific advice for PRIME products in 2025, a higher number than in 2024, when 42 requests were received.
PRIME is meant for the most promising medicines and EMA focuses its attention on medicines that have the potential to bring a major therapeutic advantage. That is why only a limited number of applications are accepted into the scheme. The acceptance rate in 2025 was 29 %, or 16 out of 56 medicines were accepted into the scheme.
Six PRIME-designated medicines were recommended for approval (Aucatzyl, Zemcelpro, Vyjuvek, Teizeild, Brinsupri, Vimkunya).
Support for clinical trials
On 31 January 2022, the CTR became applicable in the EU and the EEA. Its objective is to simplify and harmonise the authorisation of national and multinational clinical trials, making it easier for sponsors to initiate and conduct research in the EU/EEA.
Under the CTR, Member States remain responsible for the assessment, authorisation and supervision of clinical trials, and sponsors can now submit a single application for clinical trial authorisation in up to 30 European countries using the CTIS. The use of CTIS became mandatory in January 2023 for all new clinical trials applications, while ongoing trials authorised under the former CTD could transition to CTIS until 30 January 2025.
In 2025, a report analysing the three years of the CTR transition confirmed that the migration phase was successfully completed, with 5,088 clinical trials moved from EudraCT (under the CTD) to CTIS (under the CTR). CTIS is now the sole EU platform for clinical trial authorisation and oversight.
Between 31 January 2023 and 30 January 2025, CTIS received an average of 200 new initial clinical trial applications per month, including around 80 applications for multinational trials. While the number of multinational trials is expected to grow, these figures reflect a transitional period during which sponsors and other stakeholders continued adapting to the legal and procedural framework of the CTR.
With both the CTR and CTIS now being fully implemented and operational, the EU has established a more integrated and responsive clinical trial ecosystem—one characterised by greater transparency, efficiency, and collaboration to drive clinical research forward. Since its launch in 2022, CTIS has received nearly 13,000 initial applications, with more than 10,600 clinical trials authorised by EU Member States.
Recommendations for marketing authorisation
Applications for initial evaluation
EMA’s committee for human medicines, the CHMP, carries out robust scientific evaluations of medicines and issues recommendations for the European Commission, which ultimately decides whether or not to authorise a medicine for marketing throughout the EU.
Activities in the initial evaluation phase of human medicines range from pre-submission meetings with future applicants, through the evaluation by the CHMP to the granting of marketing authorisation by the European Commission. A total of 105 applications were received in 2025.
Outcome of initial evaluation2
| Therapeutic area/ Product name | New active substance | PRIME | Orphan | ATMP | Biosimiliar | Generic | Accelerated assesment | Conditional approval | Exceptional circumstances |
|---|---|---|---|---|---|---|---|---|---|
| Cancer / Oncology | |||||||||
| Anktiva | |||||||||
| Aucatzyl | |||||||||
| Aumsega | |||||||||
| Blenrep | |||||||||
| Datroway | |||||||||
| Dazublys | |||||||||
| Enzalutamide Accordpharma | |||||||||
| Ezmekly | |||||||||
| Inluriyo | |||||||||
| Itovebi | |||||||||
| Lynozyfic | |||||||||
| Ogsiveo | |||||||||
| Romvimza | |||||||||
| Tivdak | |||||||||
| Trabactedin Accord | |||||||||
| Voranigo | |||||||||
| Zemcelpro | |||||||||
| Ziihera | |||||||||
| Cardiovascular | |||||||||
| Mecitentan Accord | |||||||||
| Mecitentan AccordPharma (duplicate of Macitentan Accord) | |||||||||
| Myqorzo | |||||||||
| Rivaroxaban Koanna | |||||||||
| Dermatology | |||||||||
| Vyjuvek | |||||||||
| Winlevi | |||||||||
| Diagnostic agents | |||||||||
| GelenVita | |||||||||
| Endocrinology | |||||||||
| Acvybra | |||||||||
| Bildyos | |||||||||
| Bilprevda | |||||||||
| Bomyntra | |||||||||
| Conexxence | |||||||||
| Degevma | |||||||||
| Denbrayce | |||||||||
| Enwylma | |||||||||
| Vevzuo | |||||||||
| Yaxer | |||||||||
| Denosumab BBL | |||||||||
| Izamby | |||||||||
| Junod | |||||||||
| Zdenvi | |||||||||
| Denosumab Intas | |||||||||
| Jubereq | |||||||||
| Kefdensis | |||||||||
| Kyinsu | |||||||||
| Lynquet | |||||||||
| Oczyesa | |||||||||
| Ondibta | |||||||||
| Osqay | |||||||||
| Osvyrti | |||||||||
| Ponlimsi | |||||||||
| Rolcya | |||||||||
| Teizeild | |||||||||
| Tepezza | |||||||||
| Xbonzy | |||||||||
| Zvogra | |||||||||
| Gastroenterology/Hepatology | |||||||||
| Teduglutide Viatris | |||||||||
| Haematology/Haemostaseology | |||||||||
| Dyrupeg | |||||||||
| Eltrombopag Accord | |||||||||
| Imreplys | |||||||||
| Vivlipeg | |||||||||
| Wayrilz | |||||||||
| Immunology/Rheumatology/Transplantation | |||||||||
| Deqsiga | |||||||||
| Dawnzera | |||||||||
| Ekterly | |||||||||
| Gobivaz | |||||||||
| Gotenfia | |||||||||
| Qoyvolma | |||||||||
| Usgena | |||||||||
| Usrenty | |||||||||
| Usymro | |||||||||
| Waskyra | |||||||||
| Infections | |||||||||
| Emtricitabine/Tenofovir/ Alafenamide Viatris | |||||||||
| Emtricitabine/Rilpivirine/Tenofovir/ Alafenamide Viatris | |||||||||
| Enflosia | |||||||||
| Yeytuo | |||||||||
| Metabolism | |||||||||
| Aqneursa | |||||||||
| Maapliv | |||||||||
| Rezdiffra | |||||||||
| Sephience | |||||||||
| Tryngolza | |||||||||
| Neurology | |||||||||
| Attrogy | |||||||||
| Austedo | |||||||||
| Duvyzat | |||||||||
| Imaavy | |||||||||
| Kisunla | |||||||||
| Riulvy | |||||||||
| Ophthalmology | |||||||||
| Eyluxvi | |||||||||
| Mynzepli | |||||||||
| Afiveg (duplicate of Mynzepli) | |||||||||
| Vgenfli | |||||||||
| Eiyzey (duplicate from Vgenfli) | |||||||||
| Pavblu | |||||||||
| Skojoy (duplicate from Pavblu) | |||||||||
| Ranluspec | |||||||||
| Ryjunea | |||||||||
| Pneumology/Allergology | |||||||||
| Alyftrec | |||||||||
| Brinsupri | |||||||||
| Exdensur | |||||||||
| Nintedanib Viatris | |||||||||
| Psychiatry | |||||||||
| Zurzuvae | |||||||||
| Uro-nephrology | |||||||||
| Xoanacyl | |||||||||
| Vaccines | |||||||||
| Capvaxive | |||||||||
| mNexspike | |||||||||
| Vecpertagen | |||||||||
| Vimkunya |
In 2025, EMA recommended 104 medicines for marketing authorisation. Of these, 38 had a new active substance which had never previously been authorised in the EU.
The CHMP adopted negative opinions for seven medicines in 2025:
- Atropine sulfate FGK (atropine), for the treatment of myopia in children aged three years and older.
- Blarcamesine Anavex (blarcamesine), for the treatment of Alzheimer’s disease.
- Jelrix (cartilage-forming cells, autologous), for the treatment of cartilage defects in the knee.
- Kinselby (resminostat), for the treatment of patients with advanced stage mycosis fungoides and Sezary syndrome, two cancers of blood cells that affect mainly the skin.
- Nurzigma (pridopidine), for the treatment of adults with Huntington’s disease, an inherited condition that worsens over time and causes brain cells to die.
- Rezurock (belumosudil), for the treatment of chronic graft-versus-host disease, a condition inwhich donor cells attack the body’s organs after a transplant. A re-examination was ongoing by the end of 2025, and Rezurock eventually received a positive opinion in January 2026.
Applications for 20 medicines were withdrawn by the applicants prior to the CHMP adopting an opinion, in most cases because the data included in the application were insufficient to support a marketing authorisation.
Average assessment time
EMA has a maximum of 210 days to carry out its assessment. Within this time frame, the CHMP must issue a scientific opinion on whether the medicine under evaluation should be authorised. During the assessment, questions or concerns with the application may be raised, requiring further information or clarification from the company. In this case, the clock is stopped to give the company time to reply to the Agency. Once the reply is received, the active assessment timetable resumes.
Once issued, the CHMP opinion is transmitted to the European Commission, which has the ultimate authority to grant a marketing authorisation and will take a decision within 67 days of receipt of the CHMP opinion.
The overall total time required for the centralised procedure, from the start of the evaluation process to the adoption of a decision by the European Commission, averaged 421 days in 2025, lower than in 2024 (434 days).
For medicines evaluated under accelerated assessment, the total time from the start of assessment until the granting of authorisation was reduced by seven days compared to 2024 (from 216 to 209 days).
Post-authorisation activities
In 2025, the CHMP gave 89 positive recommendations for an extension of the therapeutic indication of already authorised medicines, including 40 for paediatric use (3).
The product information for 432 authorised medicines was updated as new safety data were made available and assessed by EMA.
Safety monitoring of medicines
EMA and EU Member States are responsible for coordinating the EU’s safety monitoring of medicines, also known as pharmacovigilance. Regulatory authorities constantly monitor the safety of medicines and can take action if there is plausible evidence that a medicine’s safety profile or benefit-risk balance has changed since it was authorised. EMA’s safety committee, the PRAC, plays a key role in overseeing the safety of medicines in the EU, covering all aspects of safety monitoring and risk management.
The Agency’s main responsibilities in relation to the safety monitoring of medicines include coordination of the European pharmacovigilance system, setting standards and guidelines for pharmacovigilance, provision of information on the safe and effective use of medicines, detecting new safety issues for centrally authorised products (CAPs), managing assessment procedures, e.g. for periodic safety update reports (PSURs), and the operation and maintenance of the EudraVigilance system.
EudraVigilance
Both EMA and the NCAs are legally required to continuously monitor the adverse drug reaction (ADR) data reported to EudraVigilance to determine whether new or changed risks have been identified and whether these risks have an impact on a medicine’s overall benefit-risk balance.
Over 1.7 million ADR reports were submitted to EudraVigilance in 2025, corresponding to almost the same number of reports received in 2024.
64 % of all reports in EudraVigilance originated outside the EEA.
Signal detection
A safety signal is information on a new or known adverse event that is potentially caused by a medicine and warrants further investigation. Signals are generated from several sources, such as spontaneous reports of suspected adverse reactions, clinical studies and the scientific literature. The evaluation of a safety signal is a routine pharmacovigilance activity to establish whether there is a causal relationship between a medicine and a reported adverse event.
In cases where a causal relationship is confirmed or considered likely, regulatory action may be necessary. This mainly comprises changes in the information on medicines available for patients (in the package leaflet) and prescribers (in the summary of product characteristics).
In 2025, 1,201 potential signals were reviewed by EMA, a decrease of 4 % compared to 2024. Approximately 68 % of these signals originated from monitoring the EudraVigilance database, highlighting its central role for safety monitoring. The PRAC assessed 60 signals. Thirty-three of these were validated by EMA and 27 by Member States. In addition to signal detection activities and assessments at PRAC level, experts from the NCAs, in collaboration with EMA, contributed to the development of signal detection methods and continuous process improvement.
Outcome of signal assessment
1,201 potential signals were identified by EMA and underwent an initial confirmatory and prioritisation review;
60 confirmed signals were prioritised and assessed by the PRAC:
- Of these 60 signals, 33 were detected and validated by EMA.
- 27 were detected and validated by EU Member States.
Out of 60 confirmed and validated signals
- 26 signals led to a product information update;
- 12 signals led to a recommendation for routine pharmacovigilance; and
- 21 signals were undergoing review by the PRAC at the end of 2024 as further data were required.
Periodic safety update reports (PSURs)
Marketing authorisation holders are required to submit an evaluation of the benefit-risk balance of a medicinal product to the regulatory authorities at regular, predefined intervals following the authorisation of a medicine. These reports summarise data on the benefits and risks of a medicine and take into consideration new or emerging safety information in the context of cumulative information on risks and benefits, both in authorised and unauthorised indications.
The Agency is responsible for procedures supporting the analysis of these reports for both CAPs and for nationally authorised medicines (NAPs) that are authorised in more than one Member State. These reports are called PSURs. When the assessment procedure involves more than one medicinal product with the same active substance, the procedures are referred to as periodic safety update single assessments or PSUSAs.
In 2025, the PRAC started the assessment of 911 PSURs and PSUSAs, of which 32 % represent single assessments of active substances only contained in NAPs. In total, 906 recommendations were issued by the PRAC based on the assessment of PSURs and PSUSAs, of which 28 % consisted of single assessments of active substances only contained in NAPs.
PSURs and PSUSAs finalised
| 2021 | 2022 | 2023 | 2024 | 2025 | |
|---|---|---|---|---|---|
| PSURs - standalone (CAPs only) finalised | 575 | 542 | 570 | 618 | 604 |
| PSURs single assessment (CAPs with NAPs) finalised | 49 | 46 | 37 | 51 | 45 |
| PSURs single assessment (NAPs only) finalised | 287 | 272 | 239 | 244 | 257 |