Support from several competent authorities for the development of innovative medicines

Coordinating the different requisites from various regulators and knowing whom to ask the questions regarding to their competency can be an obstacle to the development of a medicine but schemes involving multiple regulators can help to overcome this issue.

For developers trying to design a new medicine, knowing, understanding and complying with the many regulatory requirements at the national level and at the EU level is a primary challenge. They need to navigate the different legal and regulatory requirements and understand how to articulate them. 

Moreover, developers may want to know how to access different markets on a global scale and the rules can differ as the requirements are different from one market to another. For instance, to access the European Union market and the United States market, the rules are different. Therefore, if a developer wants to access both markets, they may need to enter into early interaction with both of the “Regional” Competent authorities to understand the necessary scientific and regulatory requirements. With this objective in mind, the EMA and the FDA have created a type of joint scientific advice called “Parallel scientific advice” between the two agencies on scientific issues.

Sometimes competent authorities are bridging the developer’s knowledge gap by creating new schemes and procedures to help them bring new and innovative medicines to patients. The different initiatives may evolve rapidly, because of the speed of development of the field or the experience gained. Thus, it could be difficult to know, understand, and follow the evolution of the different procedures available from various competent authorities at various levels when necessary (national, European, and in other regions of the world).

Moreover, the names or explanations of several procedures may be confusing. For a long time, the phrase parallel advice was the name for two types of procedures, the previously mentioned scheme between EMA and FDA and the one between EMA and HTA Bodies. It created unnecessary confusion. Since the entry into force of the new HTA Regulation , the vocabulary used and the process has been clarified. Indeed, the procedure to interact with multiple HTA bodies is now named Joint Scientific Consultations (JSCs). Moreover, it is still possible to combine consultations from both the EMA and HTA bodies at the same time through Parallel joint scientific consultations. In addition, the procedure to interact with both the EMA and FDA is called Parallel scientific advice with the United States or with the FDA. Despite an effort from clarification initiated by the HTA Regulation and expanded by the EMA, the term “Parallel” is still used in two very different procedures although it always implies the involvement of the EMA with another regulator.

Finally, the costs of procedures may be an obstacle, even if some procedures are free of charge, and incentives exists for SME’s and Academia, depending on the competent authorities involved and the procedure targeted.

Competent authorities or regulators, are creating services and procedures to facilitate answers from multiple regulators to medicine developers. The primary aim is to support medicine development and medicine’s access to patients. An implicit aim is to avoid losing ground-breaking research to the hardships of navigating the regulatory pathways in regards to the specific area of competencies and the specific regulation or legislation applicable.

There is a strong will to make different authorities come together, some countries having a history of collaboration through bilateral agreements and specific procedures.

Some international activities from agencies can allow new programs to emerge and therefore favor new collaborations, and ultimately the development and the access to new medicines. For instance, the FDA is looking into a new pilot program called Gene Therapies Global Pilot (CoGenT) that will initially include regulatory members of the International Council for Harmonisation (ICH), including the EU, the US, Japan, Canada, and Switzerland. This program is a collaboration between the standing regulatory members of the ICH. The partners can participate in internal regulatory meetings or regulatory meetings with the developer asking for the interaction. This collaboration pilot was mentioned in the ‘CY 2024 report’ from the director of the FDA (read the entire report here). The aim of this pilot is to work towards international regulatory convergence. It seems to be just a plan for now but it shows the importance given by multiple countries in working together on regulatory issues and the standardisation of regulations across different markets to help innovative medicines reach the patients.

It is essential that stakeholders are aware of the existence of these procedures and their development. A number of events are organised by regulators to create such awareness among stakeholders. Some are listed through a regular legal news watch on the  ELSIBI website. There are a clear interest and a will to enhance support to stakeholders in facilitating their interactions with regulators or competent authorities more widely by creating more spaces for conversations. It pushes competent authorities to create new procedures and clarify the requirements for a medicine to access the market or to have the most chances at accessing the market. For example, the existence of innovation offices in itself is a marker of interest for a lot of countries and of competent authorities to support the development of new innovative medicines. Also, there seems to be a will for common approaches by identifying the regional challenges and creating common procedures. For instance, the SNSA procedure is one example of a possible way to bring closer support systems regarding current issues as similar questions arose and similar evidences are needed from different National competent authorities.

Finally, there are other support systems available. It exists collaborations between several countries in the form of specific agreements such as the BENELUXA agreement between Belgium, Austria, Ireland, Luxembourg and the Netherlands in Europe (Find out more on the Beneluxa website). This partnership aims to ensure sustainable access to innovative medicines at affordable costs by bringing together multiple countries. The idea is to facilitate dialogue and the exchange of information on medicine policies in the hopes that it will have positive repercussions on medicine’s costs and policies. It also allows countries to negotiate prices with the industry together and therefore increases transparency between different countries on the pricing of medicines.

Developers can enter into contact with their National Medicines Agencies but also with the Heads of Medicines Agencies (HMA) and its working groups, HTA bodies, the EMA or/and the FDA depending on their aim and the type of interaction they need to pursue in order to commercialise their product. 

Six different procedures currently co-exist and allow developers to interact directly with several regulators:

1. If the interaction sought concerns clinical trials and the developer seeks scientific advice on both clinical trial application requirements and Marketing authorisation requirements, they should consider asking for advice through the Scientific Advice from SAWP CTCG Pilot.
2. If the interaction sought concerns a developer looking for regulatory advice on the Clinical Trial Application (CTA) dossier before submitting a Clinical Trials Application on CTIS, they could use the Pre-CTA advice pilot.
3. If the interaction sought concerns clinical trials to be conducted in more than one EU Member State, the medicine developers (often the sponsor, please see Clinical trials) should consider entering a procedure of Simultaneous National Scientific Advice (SNSA) to interact with several innovation offices from different National medicines agencies in the European Economic Area.
4. If the interaction sought concerns the evidence generation for the marketing authorisation of an ATMP in both the EU and the USA markets, the medicine developer should consider to start a procedure of EMA-FDA Parallel Scientific Advice.
5. If the interaction sought concerns the reimbursement of an ATMP (or more widely a health technology) in several EU member States, the developer should consider using the Joint Scientific Consultation procedure to interact with all HTA bodies from the European Union via the HTA Coordination Group.
6. If the interaction sought concerns the evidence generation for both the marketing authorisation at the EU level and the reimbursement of an ATMP in several EU member States, the medicine developer should consider to start a procedure of Parallel Joint Scientific Consultations to interact with the HTA Coordination group and with the EMA.

Please find below more details on the practical steps for each one of these procedures.
 

Consolidated advice pilots on Clinical Trials 

1. Scientific Advice from SAWP CTCG Pilot

The SAWP CTCG Pilot is a type of Scientific Advice on the suitability of a clinical trial design to support the Marketing Authorisation Application (MAA) at the European level if the pathway is the centralised process and/or clinical trials applications (CTA) to a National medicines Agency within a specific Member State. The pilot aims at creating harmonised view and advice on clinical trials designs for both applications (CTA and MAA) across EU Member States. It is based on an enhanced collaboration between the European Medicine Agency’s (EMA) Scientific Advice Working Party (SAWP) and the Member States’ Clinical Trial Coordination Group (CTCG).

The normal SAWP scientific advice procedure and timeline apply to the Scientific Advice from SAWP CTCG Pilot.

Involvement of ethics committee 

Ethics committees are independent bodies therefore their involvement in the scheme is complex but when needed the pilot allows the experts to reach out on a case-by-case basis.
 

Number of products admitted to the pilot 

Approximatively 10 per year with a minimum starting number of one by month considering there is no meeting in August. 
 

Applicable fees

Normal Scientific advice fees and fees incentives apply. Fees are identical to standard SAWP advice; no additional pilot charges.
Confidentiality follows standard EMA principles.
Sponsors completing the pilot will receive a questionnaire to support evaluation of pilot success.
 

Countries participating in the pilot

Steps to submit 

The developer should submit their application on IRIS. 

Please find below a comprehensive view of the steps of the pilot process: 

• The validation phase is a 30 days process.
• The evaluation and finalization phase runs from day 0 to day 40 of the process.

Outcome: a Consolidated Scientific Advice Letter

At the end of the process, the applicant receives a single consolidated advice letter, including SAWP and CTCG integrated scientific positions and MS‑specific comments (in a separate section).
 

Some important information on the advice: 

• The advice is not legally binding.
• Any deviation from the advice must be justified in future CTA or MAA submissions.
• The advice does not constitute a pre-assessment of data.

For more details on the Scientific Advice from SAWP CTCG Pilot, please see “Guidance for applicants: SAWP CTCG pilot on scientific advice ACT EU priority action on consolidated advice”.
 

2. Pre-CTA advice pilot

The Pre-CTA advice pilot is coordinated by the Member States’ Clinical Trial Coordination Group (CTCG).

The Pre-CTA advice pilot aims for sponsors/applicants planning to submit a Clinical Trial Application (CTA) to the Clinical Trial Information System (CTIS) to obtain guidance on the regulatory and technical aspects of clinical trials from assessors of the National Competent Authorities of EU Member States.
 

Eligibility to apply for the Pre-CTA advice pilot

Criteria that need to be satisfied

• The request should include up to 5 regulatory/technical questions.
• The applicant must have an almost mature protocol.
• The proposed Reporting Member State (RMS) for the future CT application in CTIS must be known.

A non-exhaustive list of regulatory topics that are covered by the Pre-CTA advice pilot  

• Clinical Trial within the scope the European Regulation on Clinical Trials.
• Low-intervention and combined Clinical Trials (links with the Medical devices Regulations).
• Regulatory request on Good Laboratory Practice (GLP) guideline.
• Regulatory request on Auxiliary Medicinal Product (AxMP) guideline.
• Operational submission issues in the Clinical Trial Information System (CTIS).
• Decentralized elements, risk-based monitoring, and other regulatory aspects of the Clinical Trials Application.

The following aspects are out of scope of the the Pre-CTA advice pilot

• Scientific aspects of Clinical trials (covered by other EU advice procedures)
• The pre-assessment of Clinical Trials Application dossier

Fees

Only Lead-Member State may charge a fee based on national rules and following national procedures.

Differences can apply depending on the status of the applicant (commercial vs. non-commercial).

There is no centralized list on the fees for the Pre-CTA advice – the applicant needs to check with individual Member States.

Member States participating in the Pre-CTA pilot

Pilot Size and Evaluation

The Initial pilot includes five procedures, followed by a review evaluation and a following optimization of the process.


Outcome and Confidentiality

The outcome of the advice is a non-legally binding advice letter but applicants should justify why they may have strayed from the given advice when submitting the formal Clinical Trials Application. 

It is not a pre-assessment of the data. 

The confidentiality and conflict-of-interest principles apply.

For more details on the Pre-CTA advice Pilot, please see “Guidance for applicants: Pre-CTA advice pilot ACT EU priority action on consolidated advice”.
 

3. Simultaneous National Scientific Advice (SNSA) to interact with several innovation offices from different National medicines agencies of the European Economic Area

SNSA is a procedure for early interaction with multiple National Medicines Agencies, at the same time. With this procedure a developer can obtain an advice from different agencies with the same set of questions and data package. 

Benefits/aim 

What are the benefits for the National Medicines Agencies involved in SNSA? 

• To know the needs of the applicants and enhance innovation.
• To support clinical development.
• To discuss the potential challenges of implementation of the European regulation on clinical trials.
• To facilitate and speed up regulatory approval.
• To avoid gaps in early regulatory support.

What are the benefits for the developer? 

• To address specific scientific/technical regulatory issues.
• To get answers from different National medicines agencies from multiple countries at the same time.
   

Steps for SNSA

When initiating the submission request

• One of the national regulators (here in the sense of National medicines agencies, mostly through their innovation office) should be chosen to be the lead from the list of participating National Competent Authorities.
  • The lead is the agency responsible for coordinating the procedure with the involved parties.
• One or more national regulator can take part in the SNSA.
  • It is now possible to involve 3 National competent authorities (Including the leader), an observer or more depending on the agreements in place and if the developer’s choice is justified.
  • "E.g. where the request relates to a clinical trial to be performed in more than 2 MSs, the involvement of additional MSs in a single SNSA procedure will be considered subject to the agreement of the NCAs and if adequately justified by the Applicant.” (Extract from the application form published in May 2025).
  • Observer: The observer is allowed to attend the meetings including the preparatory meeting between the different National medicines agencies and the formal meeting with the applicant. But the role of observer in the procedure does not allow to evaluate the application.
• The developer should send the request for SNSA to the central contact point called “coordinating unit” (PEI/AEMPS/FAGG-AFMPS) with a draft list of questions raised using the SNSA application form and giving a brief outline of the scope of the SNSA request.
  • The list of question allows the designated regulators to start designating the appropriate experts for the request.
  • The brief outline of the scope of the request includes, for instance, drug product characteristics, manufacturing process for e.g. ATMP, background of the intended (pre) clinical development project, etc.)

Formal start of the procedure

• The developer should send a cover letter, a detailed list of questions & clear position statement of the applicant for each question, the Briefing Document containing all detailed scientific and regulatory information regarding the dossier, and any additional supportive documentation.
• The procedure starts when the briefing documents are sent.
• Until day 20 minor updates can be made to the package if they have no impact on the choice of experts made. 

Validation of the briefing document 

• There is a possibility of request of other information, clarification, or resubmission.
• The procedure will formally start with the validation of the briefing document.
• After validation, the SNSA meeting will take place at the latest in the following 55 days. 

The SNSA meeting

• It will be held virtually in most cases.
• The lead agency will moderate the meeting.
• No new questions or data can be added during the SNSA procedure or the meeting. 

After the meeting

• The leading authority will ask the Applicant to draft the meeting minutes of the formal SNSA meeting using the provided template.
• The minutes should be sent to the lead and participating NCAs within 10 days after the meeting.
• The consolidated advice will be sent to the applicant by day 90 of the procedure.
• Within four weeks, the applicants should give feedback to the SNSA pilot to improve the questionnaire and the procedure.

(More details can be found in Guidance for applicants on Simultaneous National Scientific Advice (SNSA) Briefing book format and content, 22 November 2022 EMA/896929/2022 and Guidance for applicants on Simultaneous National Scientific Advice (SNSA) – phase 2 pilot – Optimized process, 4 June 2024 EMA/251446/2024.)

4. EMA-FDA Parallel Scientific Advice to interact with both the EMA in the European Union and the FDA in the United States of AmeriEMA-FDA Parallel Scientific Advice to interact with both the EMA in the European Union and the FDA in the United States of America

The EMA-FDA Parallel Scientific Advice aims to obtain feedback from both the EMA and the FDA on scientific issues and regulatory requirements.

It should be asked during the development phase of a medicine when both the European Union market and the United States market are targeted by the medicine’s developer for a future marketing authorisation and a potential commercialisation.
 

Who can request an EMA-FDA Parallel Scientific Advice?

The procedure is generally requested by a medicine developer on a voluntary basis. But the EMA and FDA may also initiate the EMA-FDA Parallel Scientific Advice process in full cooperation with the medicine developer in exceptional circumstances.

The medicine developer can be:

1. the “sponsor” of an Investigational New Drug Application in the United States,

2. the “applicant” that submits a New Drug Application or Biologics License Application in the United States, 

   or

3. a potential marketing authorisation applicant under the marketing authorisation process in the European Union.

Steps towards the Procedure 

A developer can submit a request for a Parallel Scientific Advice to the FDA and EMA at any time, there is no fixed dates to request a parallel Scientific Advice. 

• A developer submits a request for a parallel scientific advice to the Food and Drug Administration (FDA) and to the European Medicines Agency (EMA).
• Following this request, the agencies may accept or decline the request for Parallel scientific advice.
• In the case of a negative answer from the agencies, the developer will not benefit from parallel scientific advice and the process ends there.
• If the agencies accept the request, the developer will have to draft a meeting package accordingly to the SAWP procedures. 

Meeting package submission and validation phase

During this stage of the procedure, it is possible for the developer to ask for a preparatory meeting according to the SAWP procedures. 
 

Steps of the EMA-FDA Parallel Scientific Advice procedure initiated in the European Union

• The procedure begins after EMA’s validation of the meeting package. It will last between 75 and 95 days. But, if EMA does not validate the meeting package, the procedure ends.
• After EMA’s approval, the meeting package is sent to the FDA. An internal meeting is held at the FDA and another is held at the EMA SAWP.
• The FDA sends preliminary comments on the meeting package to EMA, and EMA sends a list of issues to the FDA.
• A bilateral meeting is held between the two agencies.
• Then, a trilateral meeting between the developer, the FDA and EMA is organised during which the meeting package and the diverse issues related are raised and discussed.
• Ten days after the trilateral meeting, the EMA adopts the final advice letter.
• Thirty days after the trilateral meeting, the FDA adopts the final meeting minutes. 

Please find below a flowchart on the EMA-FDA Parallel Scientific Advice procedure built from the EMA-FDA Parallel Scientific Advice Timetable available here.

For more information on the timeline of the procedure, please see the document provided by EMA.
 

Joint Scientific Consultations (JSCs) and Parallel HTACG/EMA Joint Scientific Consultations

Applicable Articles related to HTACG joint scientific consultations and parallel HTACG/EMA joint scientific consultations : Articles 16 to 21 of Regulation (EU) 2021/2282 of the European Parliament and of the Council of 15 December 2021 on health technology assessment and amending Directive 2011/24/EU (HTA Regulation).

5. Joint Scientific Consultations (JSCs) to interact with all HTA bodies from the European Union via the HTA Coordination Group

JSCs are coordinated by the Health Technology Assessment Coordination Group (HTACG) dedicated subgroup. The subgroup appoints assessors and co-assessors from different countries to monitor the process. The request can be for a new medicinal product or for an existing one but on a new indication.
 

Number of meetings per year

The Health Technology Assessment Coordination Group (HTACG) holds two quarterly meetings in the first half of the year and may increase the number to monthly meetings in the second half of the year (except in August). This possible increase depends on the number of JSCs initiated. 
 

Request period for JSC

The request period and instructions on how to submit request is published on the European Commission website here and on the HTA IT platform. 

In 2026, the periods are the following:

• 07 January to 04 February 2026
• 01 to 29 April 2026
• 03 June to 01 July 2026
• 23 September to 21 October 2026.

Aim of Joint Scientific Consultations (JSCs)

For Health Technology developers this procedure should be used to discuss the development plan of a health technology’s (here an ATMP) clinical development at an early stage. It will help developers to generate robust evidence. 

“The Coordination Group shall carry out joint scientific consultations in order to exchange information with health technology developers on their development plans for a given health technology. Those consultations shall facilitate the generation of evidence that meets the likely evidence requirements of a subsequent joint clinical assessment on that health technology. […] Joint scientific consultations shall in particular concern all relevant clinical study design aspects, or clinical investigation design aspects, including comparators, interventions, health outcomes and patient populations” (Article 16(1) HTA Regulation).
 

Eligibility criteria and the selection criteria for JSCs for medicinal products

The eligibility of a product relies on two cumulative conditions: 

• Being likely to be the subject of a joint clinical assessment pursuant to Article 7(1) of HTA Regulation, 

and

• The clinical studies and clinical investigations are still in the planning stage.

The health technology developer should also justify the product fulfils one or more of the following criteria to be selected for a JSC:

1. Unmet medical needs,
2. First in class,
3. Potential impact on patients, public health, or healthcare systems,
4. Significant cross-border dimension,
5. Major Union-wide added value,
6. Union clinical research priorities.

The answer on eligibility of the product should be given to the developer 15 working days after the end of each request period. 

For details on the eligibility of a product, interpretation of selection criteria, and selection process, please see “Guidance for the selection of Medicinal Products (MP) for Joint Scientific Consultations (JSC)”.
 

The steps of the procedure

The procedure will take approximately 4.5 months from the reception of the briefing document with annexes and references (briefing package) by the HTA secretariat via the HTA IT platform.  At day 60 a discussion meeting is held between the HTACG and the Health Technology developer. 

For details on the JCS procedure for medicinal products, please see “Procedural Guidance for Joint Scientific Consultations (JSC) on Medicinal Products (MP)”.
 

6. Parallel Joint Scientific Consultations to interact with the HTA Coordination group and with the EMA (Parallel HTACG/EMA Joint Scientific Consultations)

Developers may request to enter into a Parallel HTACG/EMA Joint Scientific Consultations while in the process of asking for a Joint Scientific Consultation. This mechanism combines a Joint Scientific consultation from the HTA Coordination group with a Scientific Advice from the European Medicines Agency (EMA). This procedure has been established by article 17 of the HTA Regulation.

For this procedure the HTACG and the EMA processes run in parallel. Even though the two work separately they coordinate key steps of the procedure and share the necessary information to allow the scheme to work seamlessly. The timetable for JSCs will be synchronised with the timing of the process for Scientific Advice (SA). The questions asked by the developer in this procedure should be different from recent scientific advice already addressed by the EMA concerning a similar product. 
 

Outcome of the scheme

The outcome will be a Scientific advice letter from EMA and a final JSC outcome document from the HTACG.

For details on the Parallel HTACG/EMA Joint Scientific Consultations procedure for medicinal products, please see “Procedural Guidance for Joint Scientific Consultations (JSC) on Medicinal Products (MP)”.

Published: 27/01/2026

Authors:

Auxane Delage, EuroGCT information officer on Ethical, Legal and Societal Issues

Aurélie Mahalatchimy, EuroGCT WP4 Convenor, UMR 7318 DICE CERIC, Aix-Marseille University, CNRS, Aix-en-Provence, France