Parallel scientific advice and special development aspects or product types

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

• Scientific advice and protocol assistance

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

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

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')

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

A pilot project enables EMA and national competent authorities to offer tailored scientific advice to not-for-profit organisations and academics (institutions and individuals) on repurposing an authorised medicine for a new indication.

The aim is to help gather or generate enough evidence to support a new indication with important public health benefits for a medicine whose marketing authorisation holder is otherwise unlikely to undertake the necessary research and regulatory steps.

This provides a way of making new treatment options available to patients if it leads to the authorisation of the new indication.

Scientific advice fees are waived automatically for eligible academic sponsors repurposing a medicine for an orphan condition. Fees will also be waived for a subset of other applicants based on the expected public health benefits and strength of the evidence in their application. 

Deadline for applicants was February 2022.

More information including eligibility criteria is available in the documents below.

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

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 PHEearlyinteractions@ema.europa.eu.

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.