EMA Emer Cooke speech at EP SANT panel
Executive Director Emer Cooke speech at the European Parliament's Committee on Public Health (SANT) on 14 July 2026 set out EMA's 2025 output, preparations for the new EU pharmaceutical framework, women's health work, and clinical-trial system progress — in what she called her last annual exchange before her mandate ends.
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Key Takeaways
- Cooke reported 104 positive recommendations for new human medicines in 2025 and 30 veterinary recommendations, including seven vaccines.
- She called the new EU pharmaceutical legislation the most significant regulatory transformation in over two decades, citing HTA, Biotech Act, Critical Medicines Act, and EHDS as linked tools.
- CTIS has processed more than 14,000 new trials since go-live about four years ago; ACT EU is running in parallel.
- Cooke said this was her last annual SANT exchange; her mandate ends in April (Board materials cite 30 April 2027).
Emer Cooke SANT speech at a glance
| Field | Detail |
|---|---|
| Speaker | Emer Cooke, EMA Executive Director |
| Forum | European Parliament Committee on Public Health (SANT) |
| Date | Brussels, 14 July 2026 (EMA published 15 July 2026) |
| 2025 human medicines | 104 positive recommendations for new medicines |
| 2025 veterinary | 30 positive recommendations (7 vaccines); highest since 1995 |
| CTIS volume | >14,000 new trials since go-live (~4 years) |
| Mandate note | Last annual SANT exchange; mandate ends April (Board: 30 April 2027) |
What did Cooke tell the SANT Committee?
EMA published the prepared text of Cooke's annual exchange of views on 15 July 2026. The speech, delivered in Brussels on 14 July, covered 2025 highlights, new pharmaceutical-framework preparations, competitiveness, women's health, and personal reflections at the end of her mandate. The full text is on EMA's page for Emer Cooke's SANT Committee speech.
Cooke thanked the Committee for collaboration and said many members already knew this was her last annual exchange because her mandate will end in April. She then walked through agency results and the legislation stack reshaping EU medicines regulation.
What 2025 numbers did EMA highlight?
For human medicines, Cooke said EMA delivered 104 positive recommendations for new medicines in 2025, many addressing unmet medical need. She named notable examples without product brand detail in the speech: a medicine for early Alzheimer's disease, a medicine to delay progression of type 1 diabetes, and a twice-yearly HIV prevention medicine she called a "game changer."
For veterinary medicines, EMA issued 30 recommendations for new medicines, including seven vaccines for animal health emergencies — the highest number of positive veterinary opinions since the Agency opened in 1995, according to the speech.
How is EMA preparing for the new pharmaceutical framework?
Cooke described the reform as the most significant transformation of the EU regulatory framework in over two decades. She said it should support innovation, competitiveness, and patients through more efficient evaluation, targeted unmet-need incentives, shortened timelines, and better availability across Member States.
She placed the package alongside the Health Technology Assessment Regulation, the Biotech Act, the Critical Medicines Act, medical-devices revision, and the European Health Data Space. EMA's own reform page notes political agreement on 11 December 2025, with adopted acts expected to enter into force in 2026 and a transition period through 2028. See EMA's reform of the EU pharmaceutical legislation overview.
When political agreement landed, EMA called it a once-in-a-generation overhaul that would simplify committee structures and modernise how medicines are developed and authorised. That earlier statement is on EMA's December 2025 welcome of the political agreement.
What did Cooke say about clinical trials and CTIS?
On clinical trials, Cooke said EMA processed more than 14,000 new trials through the Clinical Trials Information System since it went live four years ago. Trials sit in a publicly accessible database, and EMA made an interactive clinical trial map available for patients and healthcare professionals. ACT EU, she said, is helping transform how trials are initiated, designed, and run.
Those CTIS figures align with EMA's June 2026 Management Board highlights, which reported more than 14,000 clinical trial applications under the Clinical Trials Regulation between early 2022 go-live and the end of May 2026. The Board also flagged Biotech Act proposals that would change the CTR and therefore CTIS. See EMA Management Board highlights of the June 2026 meeting.
What else did the speech cover?
On women's health, Cooke said sex-related gaps remain in disease understanding, treatment response, and medicines for conditions specific to women. EMA is monitoring trial representation, requiring tailored dosages and warnings where needed, and expanding work on medicines in pregnancy and lactation. A Women's Health Workshop with network partners is planned for September.
She also cited four public health emergencies during her mandate — COVID-19, mpox, hantavirus, and ongoing Ebola support via the Emergency Task Force — and thanked MEPs who steered EMA's extended mandate, the pharma package, EHDS, and related files.
For related NovaPharma EU regulatory context, see PRAC June 2026 highlights and the EU Commission and EU drugs agency 2026 drug report.
What remains open after the speech?
The published text is a check-against-delivery prepared speech. It does not name the Alzheimer's, type 1 diabetes, or HIV products, does not set a date for final adopted pharmaceutical acts beyond the Agency's broader 2026–2028 implementation framing, and does not quantify Biotech Act impacts on CTIS beyond the Board's separate resource warnings.
Succession timing is clearer in Board materials (mandate end 30 April 2027) than in the speech's "April" shorthand. Sponsors should treat the SANT exchange as a policy status report, not as product-level guidance.
Related NovaPharma coverage
- PRAC June 2026 highlights: valproate signal review
- EU Commission and EU drugs agency 2026 drug report
- Vanda Pharmaceuticals EMA orphan drug designation opinion
Frequently Asked Questions
What did Executive Director Emer Cooke say at the European Parliament SANT Committee?
In her July 2026 exchange of views, Cooke reported 104 positive recommendations for new human medicines in 2025, framed new EU pharmaceutical legislation as a once-in-two-decades reform, and said CTIS has processed more than 14,000 new trials since go-live.
When does Emer Cooke's EMA mandate end?
Cooke told the Committee this was her last annual exchange of views because her mandate will end in April. EMA's Management Board has separately noted that the next Executive Director will succeed Cooke when her mandate ends on 30 April 2027.
How many clinical trials has CTIS processed according to EMA?
Cooke said EMA processed more than 14,000 new trials through the Clinical Trials Information System since it went live four years ago. EMA's June 2026 Management Board highlights likewise reported more than 14,000 CTR applications by the end of May 2026.
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