Regulatory guide

From CHMP opinion to EU approval: how the centralised procedure works

What EMA’s CHMP does, how the 210-day evaluation and clock stops work, what happens after a positive or negative opinion, and what the 2026 EU pharma package changes.

PharmaRadar360 Editorial · Published October 14, 2026 · 8 min read

Key points

EMA’s Committee for Medicinal Products for Human Use (CHMP) evaluates the application; the European Commission grants the authorisation.
The evaluation takes up to 210 active days, plus clock stops while the applicant answers questions.
After a CHMP opinion, the Commission issues its legally binding decision within 67 days.
Accelerated assessment cuts the evaluation to 150 days; conditional marketing authorisation allows approval on less complete data for unmet needs.
The EU pharma package adopted in 2026 shortens the standard evaluation to 180 days once it applies, 24 months after entry into force.

Who does what

Medicines authorised through the centralised procedure receive a single marketing authorisation valid across the EU. The scientific work is done at the European Medicines Agency by the CHMP, with input from the safety committee (PRAC) and, for advanced therapies, the Committee for Advanced Therapies (CAT). The CHMP’s output is an opinion: a recommendation on whether the medicine should be authorised and on what terms.

The European Commission is the authorising body. It turns the opinion into a legally binding decision, which EMA notes is issued within 67 days of receiving the recommendation.

The evaluation timetable

The clock runs in active days and stops whenever the applicant is preparing answers, which is why real-world timelines are longer than 210 calendar days.

Standard centralised evaluation
Stage	What happens
Day 1 to 120	Rapporteurs assess the dossier; the CHMP adopts a list of questions. The clock stops, usually for up to three months, while the applicant responds.
Day 121 to 180	Responses are assessed; by day 180 the CHMP discusses an updated report, usually with a list of outstanding issues. The applicant typically has up to one month to answer.
Oral explanation	If major objections remain, the applicant or the CHMP can request an oral explanation before the committee.
By day 210	The CHMP adopts its opinion, positive or negative, including the proposed product information.
Within 67 days of the opinion	The European Commission issues the marketing authorisation decision.

Positive opinion, negative opinion and re-examination

A positive opinion is the moment most news coverage calls an “EU recommendation”. It is a strong signal, but the medicine is not yet authorised: the Commission decision follows, and only then can the product be marketed. EMA publishes outcomes after each monthly CHMP meeting in its meeting highlights.

If the opinion is negative, the applicant can ask for a re-examination within 15 days of being notified. The re-examination lasts up to 60 active days and ends with a final opinion. Applicants also sometimes withdraw an application before an opinion is reached; EMA publishes information on withdrawn applications too.

Faster and earlier routes

Accelerated assessment: for medicines of major public health interest, particularly therapeutic innovation, the CHMP can reduce the evaluation from 210 to 150 days.
Conditional marketing authorisation: allowed when the benefit-risk balance is positive, comprehensive data are likely to follow, the medicine meets an unmet medical need, and the benefit of immediate availability outweighs the risk of incomplete data. It is valid for one year, renewable annually, and converts to a standard authorisation once the obligations are fulfilled.
PRIME (priority medicines): launched in 2016 to support medicines that may address an unmet need to a significant extent. It offers early scientific advice, early appointment of a rapporteur and confirmation at submission of potential eligibility for accelerated assessment.

What the 2026 EU pharma package changes

The EU’s revised pharmaceutical legislation, politically agreed in December 2025 and adopted by the Council in September 2026, shortens the standard EMA evaluation from 210 to 180 days, keeps a 150-day route for medicines of major public health interest, and states the intention that the Commission decide within 46 days instead of 67. It also restructures regulatory protection: data protection stays at eight years, while baseline market protection falls from two years to one, with possible extensions.

These changes do not apply immediately. The regulation becomes applicable 24 months after it enters into force, so applications in the meantime follow the current timetable described above.

How to follow EU decisions

Read the CHMP meeting highlights each month for new positive and negative opinions and new indications.
Check the medicine’s page in EMA’s medicines database for the European public assessment report and product information.
Confirm the Commission decision and date in the Union Register of medicinal products.
On PharmaRadar360, the regulators directory links to EMA, the Commission and national competent authorities, and the drug approvals view collects regulator announcements.

Sources

This guide is general information for professionals, written from the official sources listed above. It is not legal, regulatory or medical advice. Rules change: confirm details with the regulator before relying on them.