# EMA's first phased review reached a positive opinion. Is this the future of EU marketing authorisation?

> On 15 October 2026 the CHMP recommended Rasonque (daraxonrasib) after EMA's first phased review, in which complete quality, non-clinical and clinical packages were assessed before the full application. The new EU Regulation will make phased review a standing option. A shorter assessment clock is not automatically a shorter regulatory programme: part of the work moves before Day 0.

Canonical: https://rafihive.com/insights/ema-phased-review-marketing-authorisation  
Author: RafiHive Regulatory Team, RafiHive  
Category: Regulatory Updates  
Published: 2026-10-16  
Last reviewed: 2026-10-16

## What happened on 15 October 2026?

EMA's human medicines committee (CHMP) recommended a marketing authorisation for Rasonque (daraxonrasib), from Revolution Medicines, for adults with metastatic pancreatic adenocarcinoma who have received at least one previous treatment. It is the first medicine EMA has taken through a phased review.

The phased review began in early July 2026; EMA announced it on 7 July. Instead of waiting for a complete marketing authorisation application, the CHMP assessed the quality, non-clinical and clinical data in phases, as the company submitted them. EMA says this let the committee start 'several months before the anticipated submission of the complete application', and that it 'shortened the assessment time to less than 150 days'. For comparison, EMA gives up to 210 active days for a standard evaluation, around a year overall once the company's time to answer questions is included.

Daraxonrasib had been identified as a high-priority medicine under EMA's Cancer Medicines Pathfinder project and received orphan designation on 20 April 2026. EMA says the European Commission will fast-track its decision.

> This was a pilot. Phased review is not yet a procedure an applicant can file for. EMA chose this medicine case by case, ahead of the new pharmaceutical legislation that will give phased review a legal basis.

## What is a phased review, and how is it different from rolling review?

A phased review assesses complete data packages, module by module, before the full application is submitted. That is a deliberate design choice. EMA's presentation on the process names the difference from the rolling reviews it ran during the COVID-19 pandemic as the key one: individual modules are reviewed as complete packages, not as data trickling in from ongoing studies.

| Route | When assessment starts | What is assessed | Who decides |
| --- | --- | --- | --- |
| Standard centralised procedure | After a complete application is validated | The whole dossier, on a 210-day active clock plus clock stops | The applicant submits |
| Accelerated assessment | After a complete application is validated | The whole dossier, on a 150-day clock | The applicant requests; the CHMP accepts or refuses |
| Rolling review (COVID-19 pandemic) | Before the application, as data emerged | Data from ongoing studies as they became available | EMA, during the COVID-19 public health emergency |
| Phased review | Before the application, module by module | Complete quality, non-clinical and clinical packages | EMA offers it, on CHMP advice |

So phased review is not Europe's version of pandemic rolling review. Its closest relative is probably the FDA's rolling review for fast-track products, where completed sections of an application can be submitted and reviewed before the rest. Under FDA guidance, the review clock for the application starts only once the final section arrives. EMA has not yet said how its own clock will be defined for phased reviews.

## What does the new EU Regulation say about phased review?

The new Regulation laying down Union procedures for the authorisation and supervision of medicinal products, adopted by the Council on 28 September 2026 and awaiting Parliament's vote, puts phased review into law. In the Council's first-reading text, Article 7(2) provides that 'the Agency may offer to the applicant a phased review of complete data packages for individual modules' for medicines that:

- are likely to address an unmet medical need and are expected to be of major interest from the point of view of public health, particularly regarding therapeutic innovation;
- are antimicrobials with certain characteristics, or target pathogens in the critical or high group of the WHO bacterial priority pathogens list or an equivalent Union list; or
- are intended for use in a potential or recognised public health emergency.

Three details matter. First, the Agency offers phased review; the applicant cannot demand it. Accelerated assessment, by contrast, is something the applicant requests. Second, the offer follows CHMP advice on the criteria and on 'the maturity of the data concerning the development'. Third, EMA may suspend or cancel a phased review at any stage if the CHMP considers the data not mature enough or the medicine no longer meets the criteria.

The same Article shortens the standard CHMP timeline from today's 210 days to 180 days from a valid application, and keeps accelerated assessment at 150 days. EMA's presentation is explicit about what is missing: the Regulation sets the categories, but 'the operational criteria for eligibility, data maturity and discontinuation are still to be defined'. EMA's slide refers to the provision as Article 6(2), the numbering of an earlier draft.

## Did phased review make the authorisation faster?

Probably, for this medicine. But one case does not tell us by how much, and EMA's comparison needs careful reading.

- There is no counterfactual. We do not know how long a standard or accelerated assessment of the same dossier would have taken.
- The case was exceptional. EMA reports median overall survival of 12.4 months against 6.7 months on chemotherapy, in a disease with very limited treatment options and a Pathfinder priority behind it. Strong data and high priority shorten any procedure.
- The clocks are not like for like. 'Less than 150 days' is set against 'up to 210 active days' and 'around a year overall'. EMA does not say whether the 150 days run from the first phased package or from the complete application, or whether they are active or calendar days.
- The work before the first package is on no clock. Between the start of the phased review in early July and the opinion on 15 October lie about three and a half months. The time the company spent getting each module complete before it went in is not part of that figure.

> A shorter assessment clock is not automatically a shorter regulatory programme. Some of the work has simply moved before Day 0.

## What moves before Day 0

For an applicant, phased review changes the shape of the project more than its length. A standard application lets the dossier come together in parallel and go in once. A phased review asks for complete modules early and then runs assessment and authoring at the same time.

- Module completeness earlier. Each package has to be complete when it goes in. In many fast-moving programmes, quality is the module that is ready last; in a phased review it may have to be ready first.
- Questions while writing. Assessors' questions on one module arrive while the team is still finalising the next. EMA's presentation lists 'the continuous question and answers and the different modular submissions' as part of what the pilot is testing.
- Consistency across time. Modules submitted weeks apart still have to tell one story: the same formulation, the same dose, the same specifications, the same population.
- Data maturity as a gate. The Regulation makes data maturity the condition for offering, and for continuing, a phased review. A package that is not mature enough is a reason to stop the procedure, not just to raise a question.
- Two procedures at once. Daraxonrasib is in scope of the EU HTA Regulation, and EMA notes the joint clinical assessment was initiated alongside the phased review.

## The questions the pilot has to answer

EMA calls the pilot 'learning by doing'. The questions RA teams need answered before phased review becomes routine:

1. Which medicines will qualify, and how will 'unmet medical need' and 'major interest from the point of view of public health' be applied in practice?
2. How mature does a module have to be before a phase can start, and who judges it — the CHMP alone, or in pre-submission dialogue with the applicant?
3. What happens when later data change assumptions made in an earlier phase, for example a dose change that affects quality specifications already assessed?
4. How are updated analyses handled? EMA's notes give two data cut-offs for Rasonque, 10 February 2026 for progression-free survival and 15 June 2026 for overall survival.
5. If a phased review is suspended or cancelled, what happens to the assessment already done, and how does the application continue?
6. How is the procedure's clock defined, and how will EPARs record what was assessed in which phase?
7. What does it demand of EMA? The presentation says the demands on assessors, rapporteur teams and the wider network 'are still to be evaluated'.

## How does phased review interact with the EU HTA joint clinical assessment?

Since 12 January 2025, medicines with a new active substance for cancer, and advanced therapy medicinal products, whose centralised applications are submitted from that date also go through a joint clinical assessment under the HTA Regulation (EU) 2021/2282. The JCA is independent of EMA's assessment and coordinated by the HTA secretariat in the European Commission, but its scoping and dossier deadlines are set relative to the marketing authorisation procedure under Implementing Regulation (EU) 2024/1381.

That link matters more in a faster procedure. When the EMA timetable compresses, so does the time to prepare the JCA dossier, while the same clinical team is answering CHMP questions. EMA's presentation lists the interaction with the HTA secretariat as one of the things the pilot is meant to teach. For products in JCA scope, a phased review plan without a JCA plan is half a plan.

## What is confirmed and what is not?

Status as of 16 October 2026:

| Status | What |
| --- | --- |
| Confirmed: the opinion | The CHMP adopted a positive opinion on Rasonque on 15 October 2026, after a phased review that started in early July 2026. The Commission decision is pending. |
| Confirmed: EMA's figures | EMA states the phased review shortened assessment to less than 150 days, against up to 210 active days and around a year overall for a standard evaluation. |
| Adopted by the Council; Parliament's vote pending | Phased review for three categories of medicine, offered by EMA on CHMP advice, in Article 7(2) of the new Regulation; 180-day standard and 150-day accelerated timelines. |
| Still to be defined | Operational criteria for eligibility, data maturity and discontinuation; how the clock is counted; how questions are managed across modules; fees. |
| Not known yet | When the Regulation applies, and whether EMA will offer further phased reviews before then. EMA says it will consider further medicines case by case. |

## What RA teams should do now

Phased review will be offered, not requested, and only for a minority of products. For those products, it rewards preparation that starts long before submission.

1. Identify candidates: products addressing an unmet medical need, priority antimicrobials, and products already in PRIME or the Cancer Medicines Pathfinder.
2. For those, plan module completeness, not just a submission date. Ask which module could go in first and what would have to be locked to make it complete.
3. Bring CMC forward. If quality is normally the last module ready, find out what it would take to make it the first.
4. Plan for parallel work: a team answering assessors on one module while finalising another, with clear ownership of cross-module consistency.
5. Agree a data cut-off strategy, and how updated analyses would be submitted into a phased procedure.
6. If the product is in JCA scope, plan the JCA dossier against the compressed timetable, not the standard one.
7. Watch for EMA's operational criteria, the Rasonque EPAR, Parliament's vote and publication of the Regulation, and the next phased reviews EMA announces.

## Our view: phased review rewards dossier readiness, not dossier speed

Phased review is a good idea, and the first result is promising. Assessing a complete quality package while the clinical package is being finalised uses regulator time that a standard procedure leaves idle, and for medicines like daraxonrasib, weeks matter to patients.

But it is better understood as front-loading than as shortening. The assessment starts earlier because the applicant is ready earlier. The companies that benefit will be the ones that can lock a module and keep it true while the rest of the dossier moves: consistent data, controlled versions, a clear record of what was submitted in which phase and what has changed since. That is not new regulatory work. It is today's regulatory work, done under more pressure and earlier.

## Where RafiHive fits

RafiHive answers from a reviewed knowledge base of official EU/EEA regulatory sources, with each document's legal status and version recorded. Until the new Regulation applies, a question about centralised procedure timelines is answered against Regulation (EC) No 726/2004 and current EMA guidance, and phased review is described as what it is today: a pilot with a legal basis on the way. When EMA publishes its criteria and the Regulation is in the Official Journal, they become sources with a status and an application date.

## Official sources

- [EMA: EMA recommends authorisation of Rasonque for metastatic pancreatic cancer (15 October 2026)](https://www.ema.europa.eu/en/news/ema-recommends-authorisation-rasonque-metastatic-pancreatic-cancer)
- [EMA: EMA fast tracks review of a medicine for metastatic pancreatic cancer (7 July 2026)](https://www.ema.europa.eu/en/news/ema-fast-tracks-review-medicine-metastatic-pancreatic-cancer)
- [EMA: Agency phased review process — presentation to the Industry Stakeholder Group](https://www.ema.europa.eu/en/documents/presentation/presentation-agency-phased-review-process_en.pdf)
- [Council of the EU: Position at first reading on the Regulation laying down Union procedures for the authorisation and supervision of medicinal products for human use, document 7105/2/26 REV 2 (28 September 2026)](https://data.consilium.europa.eu/doc/document/ST-7105-2026-REV-2/en/pdf)
- [EUR-Lex: Regulation (EC) No 726/2004 (current centralised procedure)](https://eur-lex.europa.eu/eli/reg/2004/726/oj)
- [EUR-Lex: Commission Implementing Regulation (EU) 2024/1381 on joint clinical assessments of medicinal products](https://eur-lex.europa.eu/eli/reg_impl/2024/1381/oj)
- [US FDA: Expedited Programs for Serious Conditions — Drugs and Biologics (guidance, rolling review)](https://www.fda.gov/regulatory-information/search-fda-guidance-documents/expedited-programs-serious-conditions-drugs-and-biologics)

## Changes since first publication

- 2026-10-16: First published after the CHMP's positive opinion on Rasonque (daraxonrasib) on 15 October 2026, based on EMA's announcements of 7 July and 15 October 2026, EMA's presentation on the phased review process and Article 7 of the Council's first-reading text of the new Regulation (document 7105/2/26 REV 2).

This content supports research and preparation. Confirm current source versions and have a qualified regulatory professional review decisions before use.