Parallel scientific advice and special development aspects or product types

The European Medicines Agency (EMA) carries out scientific advice in cooperation with other decision-making bodies in the European Union (EU) and beyond. Some of these processes have distinct purposes and refer to specific product types. For instance, EMA can participate in parallel joint scientific consultations with the Member State Coordination Group on HTA (HTACG). EMA also provides scientific advice for biosimilar medicines and for human medicines required in public health emergencies, among others.

To find out more about EMA's role in providing and enabling scientific advice, see: 

• Scientific advice and protocol assistance

Parallel joint scientific consultations with the Member State Coordination Group on HTA (HTACG)

Regulation (EU) 2021/2282 on health technology assessment (HTAR) established a framework for joint scientific consultations (JSC) at EU level. 

The Member State Coordination Group on HTA (HTACG) carries out these joint scientific consultations. 

Under this regulation, medicine developers may request scientific advice from EMA in parallel with the joint scientific consultations that the coordination group provides.

The parallel consultation aims to allow developers to obtain feedback from regulators and and health technology assessment (HTA) bodies in EU Member States on their evidence-generation plans. This supports decision-making on marketing authorisation and reimbursement of new medicines. 

As an outcome of the procedure, developers receive a scientific advice letter from EMA and an outcome document from HTA bodies.

Developers wishing to apply for a parallel joint scientific consultation procedure must first contact the European Commission's HTA secretariat to obtain access to their HTA IT platform. Developers then need to submit their request form during the request periods that the coordination group publishes in its annual work programme.

For more information on application slots for the various request periods, please see:

• Joint Scientific Consultations

The coordination group selects applications in line with the selection criteria and other related information that the Commission makes available: 

• Guidance for the selection of Medicinal Products (MP) for Joint Scientific Consultations (JSC)
• Procedural Guidance for Joint Scientific Consultations (JSC) on Medicinal Products (MP)
• Briefing document template for Parallel HTA Coordination Group (HTACG)/European Medicines Agency (EMA) Joint Scientific Consultation (JSC) for Medicinal Products (MP)
• Dates of 2026 Scientific Advice Working Party - Human (SAWP-H) meetings and submission deadlines for scientific advice, protocol assistance, qualification of novel methodologies and HTACG/EMA parallel Joint Scientific Consultation (JSC) requests

For more information on EMA's role in HTA processes, see: 

• Member State Coordination Group on HTA (HTACG)
• Health technology assessment bodies

Parallel scientific advice with the United States

The Agency provides scientific advice and protocol assistance in parallel with the United States Food and Drug Administration (FDA).

EMA and FDA launched a pilot programme in September 2021 to provide parallel scientific advice to marketing authorisation applicants for hybrid or complex generic products. 

For more information, see:

• United States

General principles: European Medicines Agency-Food and Drug Administration parallel scientific advice

Timeline: European Medicines Agency-FDA parallel scientific advice

Pilot programme: European Medicines Agency-Food and Drug Administration parallel scientific advice for hybrid/complex generic products - General principles

Scientific advice on clinical trials

National competent authorities are handling clinical trial authorisation in the EU. 

There are various ways of seeking scientific advice, depending on the context. For information, see:

• Accelerating clinical trials in the EU: Scientific advice (section on 'mapped information on current voluntary procedures')

Two consolidated advice pilots enable medicine developers to improve the quality of applications for clinical trials.

The first pilot offers scientific advice on clinical trials and requirements for marketing authorisation applications. 

This type of advice is made available via increased coordination between EMA's Scientific Advice Working Party (SAWP) and the Clinical Trials Coordination Group (CTCG) operating under the Heads of Medicines Agencies (HMA).

The second pilot provides technical and regulatory support on the dossier of a clinical trial application prior to its submission through the Clinical Trials Information System (CTIS).

The two pilots are part of the Accelerating Clinical Trials in the European Union (ACT EU) initiative. They were launched in June 2024. 

For more information, see:

• Clinical Trials Coordination Group (CTCG)
• Accelerating clinical trials in the EU: Scientific advice (section on 'Consolidated advice pilots')

Scientific advice from EMA's Emergency Task Force

EMA's Emergency Task Force (ETF) provides scientific advice on clinical trials and requirements for marketing authorisation of medicines used in declared and potential public health emergencies and threats. 

This helps harmonise requirements and improve the quality of applications for clinical trials.

Related medicines include those:

• targeting public health emergencies (like COVID-19 and Mpox);
• addressing antimicrobial resistance (AMR);
• tackling outbreaks (like Zika and Dengue).

The ETF provides this type of scientific advice in collaboration with clinical trial and ethics experts from EU / EEA countries.

The aim is to facilitate development of medicines for targeting declared and potential public health emergencies and threats.

For more information, see: 

• Clinical trials in human medicines: Scientific advice for public health emergencies and threats
• Scientific advice for public health emergencies and threats

Model-informed drug development scientific advice and protocol assistance: Pilot procedure

EMA is running a pilot procedure providing scientific advice and protocol assistance on model‑informed drug development (MIDD).

Model‑informed drug development refers to the use of quantitative modelling and simulation approaches to generate evidence informing drug development and regulatory decisions. These approaches integrate non-clinical data, clinical data, and prior knowledge such as drug- and disease-specific information.

The pilot is intended for drug development programmes in which MIDD evidence is expected to play a key role in regulatory decision-making.

It enables in-depth interaction between drug developers and regulators for development programmes with a high model impact.

The pilot aims to achieve the following:

• Facilitate expert-to-expert scientific dialogue
• Carry out multidisciplinary communication
• Promote regulatory learning
• Support consistent assessment of MIDD evidence across therapeutic areas
• Support the implementation of the ICH M15 model‑informed development guideline

EMA assesses pilot eligibility based on the following criteria, as described in ICH M15:

• Question of interest
• Context of use
• Expected model impact

Pilot applicants must follow EMA's guidance on requesting requesting scientific advice or protocol assistance. 

They must submit comprehensive documentation. This should include table(s) of assessment of MIDD evidence, and related model analysis plans and / or reports.

EMA assesses applications following the standard timetable of a 'Day 70 procedure'. This includes a discussion meeting, unless applicant and regulators mutually decide to cancel the meeting.

EMA launched this pilot in May 2026.

It will capture and consolidate learnings until this procedure is deemed ready for standard implementation.

For more information, see:

• ICH M15 guideline on general principles for model-informed drug development
• Requesting scientific advice or protocol assistance from EMA

Post-authorisation safety studies (PASS)

EMA encourages medicine developers to seek scientific advice for PASS protocols. This voluntary, optional procedure will help to improve the design of studies meant to collect further information on a medicine's safety once it is on the market.

EMA ran a 12-month pilot for this procedure between July 2015-2016.

For more information, see:

• Question on 'Scientific advice for safety studies' on Post-authorisation safety studies: questions and answers

Scientific advice on medicine repurposing

Medicine repurposing refers to development of authorised medicines in not-yet-approved therapeutic indications. Academic and not-for-profit organisations often perform this development.

EMA and national competent authorities (NCAs) can make use of an established procedure to offer scientific advice for eligible requests from not-for-profit organisations. This type of advice is offered free of charge. 

In this procedure, EMA also provides support to researchers and developers from the academic sector on a case-by-case basis. This may include:

• Briefings to academia
• Scientific advice
• Facilitating discussions between regulators, academia and pharmaceutical industry

In addition, the reform of the EU pharmaceutical legislation features measures to facilitate and encourage repurposing of off-patent medicines for new therapeutic uses. This includes a specific incentive and a dedicated support scheme for SMEs and not-for-profit developers.

For more information, see:

• Academia
• Reform of the EU pharmaceutical legislation

Repurposing pilot

EMA and the Heads of Medicines Agencies (HMA) conducted a pilot providing tailored scientific advice to not-for-profit organisations and academics on repurposing authorised medicines for new indications. 

The pilot provided the basis for the established procedure on scientific advice for medicine repurposing.

It served as a test for a proposed European Commission framework to support not-for-profit organisations and academia in medicine repurposing. The Commission's expert group on Safe and Timely Access to Medicines for Patients (STAMP) proposed this framework.

It guided not-for-profit organisations in gathering or generating sufficient and relevant evidence to support a new indication with important public health benefits. The goal was to make new treatment options available to patients.

During the pilot, EMA and participating NCAs (as applicable) waived scientific advice fees for eligible academic sponsors repurposing a medicine. This was based on either the orphan status, a targeted paediatric indication or the expected public health benefits and strength of the evidence included in the repurposing application.

The pilot ran between October 2021 and December 2024. 

A report of the pilot is available containing findings and recommendations to address opportunities and challenges identified between 2021 and 2024.

It emphasises that EMA and HMA, as the European medicines regulatory network, remain committed to supporting the repurposing of authorised medicines. They encourage not-for-profit organisations to seek advice early in a repurposing development programme

EMA and HMA published the pilot report in July 2025.

EU Repurposing pilot

Summary:

Report by the EU regulatory network on the learnings and recommendations from testing a proposal for a framework to support not-for-profit organisations and academia in drug repurposing.

Question and Answers on repurposing pilot project on proposal for framework to support not-for-profit organisations and academia in repurposing authorised medicines

Page update history

An update log is available to show the date and summary of changes to this webpage. It does not include updates to linked documents or minor edits like typos or broken link fixes.

The tracking of updates begins in May 2026.

See update history

12 May 2026

• Section on 'Model-informed drug development scientific advice and protocol assistance: pilot procedure' added
• Section on 'Scientific advice on biosimilars' removed as information is obsolete
• Section on 'Scientific advice on medicine repurposing' updated to reflect established procedure and progress with the reform of the EU pharmaceutical legislation