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. 

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)
• Joint Scientific Consultations

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

• Health technology assessment bodies
• Dates of 2025 Scientific Advice Working Party (SAWP) meetings and submission deadlines for scientific advice, protocol assistance, qualification of novel methodologies and HTACG/EMA parallel Joint Scientific Consultation (JSC) requests

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 on the pilots and guidance on how to apply, see:

• Accelerating clinical trials in the EU: Scientific advice (section on 'Consolidated advice pilots')

Scientific advice on 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

A report is available on a pilot which provided tailored scientific advice to not-for-profit organisations and academics on repurposing authorised medicines for new indications.

The report contains findings and recommendations to address opportunities and challenges identified during the pilot.

EMA and the Heads of Medicines Agencies (HMA) published the pilot report in July 2025.

EMA and HMA conducted the repurposing pilot between October 2021 and December 2024. 

The pilot 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. 

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.

Continued support to repurposing medicines

The pilot report 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 national competent authorities (NCAs) can offer scientific advice free of charge for eligible requests from not-for-profit organisations.  

In addition, EMA continues to provide 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

The Commission proposals for the reform of the pharmaceutical legislation also feature 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.

How repurposing pilot worked

The pilot 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.

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

Submission form - Repurposing pilot project for authorised medicines

Scientific advice on biosimilars

EMA offers tailored scientific advice on development programmes of new biosimiliar medicines. 

The tailored procedure advises developers on the studies they should conduct, based on a review of the quality, analytical and functional data they already have available.

More specifically, tailored scientific advice can help assess cases:

• requiring confirmation that the biosimilar pathway is suitable following detention of significant differences between the biosimilar candidate and the reference medicinal product in terms of physicochemical characterisation, biological activity, purity and quality attributes;  
• proposing a scaled down clinical development programme based on the quality data available, namely cases where the programme would deviate from the available guidance (e.g. omission of dedicated clinical efficacy and / or safety studies).

EMA will not accept requests for tailored advice without proper justification. 

The tailored scientific advice procedure is open to all types of biosimilars and companies are encouraged to request a pre-submission meeting to review the suitability of the data package. Applicants should note that EMA's Scientific Advice Working Party (SAWP) will need an extra month in addition to normal scientific advice timelines to review applications.

For further information, please see:

• Biosimilar medicines: Overview

Questions and Answers on the tailored scientific advice to support step-by-step development of new biosimilars

Reference Number: EMA/263753/2024 Summary:

Tailored scientific advice to support step-by-step development of new biosimilars

Tailored Scientific Advice for biosimilar development: report on the experience from the pilot (2017-2020)

Reference Number: EMA/297462/2021 Summary:

Tailored Scientific Advice for biosimilar development: report on the experience from the pilot (2017-2020)

Scientific advice on medicines intended for a disease causing public health emergency

EMA has a dedicated Emergency Task Force (ETF) to support its Committee for Medicinal Products for Human Use (CHMP) in providing scientific advice for new or repurposed human medicines that are intended to treat, prevent or diagnose a disease causing a declared public health emergency.

On a case-by-case basis, the ETF also provides advice on medicines targeting selected pathogens that can potentially cause a public health emergency.

EMA encourages developers of such medicines to contact the Agency early if they are interested in the following procedures:

• Early guidance on medicine development plan (when the plan is not yet suitable for formal scientific advice)
• Requesting scientific advice
• Applying for a marketing authorisation

They can contact EMA by writing to [e-mail].

Early contact is particularly important during a declared public health emergency.

When submitting a request for scientific advice, developers should indicate in their application form in which Member State(s) they intend to run clinical trials. The ETF requires this information because it involves clinical trial experts from these Member State(s) in preparing the scientific advice, in order to facilitate approval of the trial later in the process.

Scientific advice on the clinical aspects of medicine development or on clinical trials protocols is free of charge for medicines intended for a disease causing public health emergency.

The procedure generally follows an accelerated timetable.

For information, see: 

• Public health threats
• COVID-19 guidance: Research and development: Clinical trials for COVID-19 medicines.