Early development advice services

EMA has developed a consolidated list of available guidance and opportunities for interaction in the development phase of a medicinal product.

EMA offers medicine developers several opportunities for early dialogue and consultation before submitting a marketing authorisation application. This is intended to provide regulatory and scientific support to facilitate the preparation of applications and enable a smooth validation and assessment procedure.

In addition to making use of these services, medicine developers can also:

Main procedural advice and guidance for medicine development

Scientific advice for human medicines

Scientific Advice general information

Scientific advice is advice to a medicine developer on the appropriate tests and studies in the development of a medicine. Protocol assistance is a special form of scientific advice, reserved for medicines with orphan designation. Scientific advice and protocol assistance

How to submit a request

Procedural advice for requesting scientific advice and protocol assistance. Requesting scientific advice or protocol assistance from EMA

Parallel EMA-FDA scientific advice

Parallel EMA-FDA scientific advice should focus primarily on important breakthrough drugs or important safety issues. 

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

Parallel consultationwith regulators and health technology assessment bodies, provides feedback from regulators and HTA bodies at the same time, at any point in the developmental lifecycle of medicines. 

Guidance on parallel EMA / EUnetHTA 21 Joint Scientific Consultation

Paediatric development

General information and guidance

Definitions, links to submission templates and deadline, and further information on paediatric procedures. Paediatric investigation plans

European Commission Guideline on PIP/waiver applications

Guideline from the European Commission on the format and content of applications for agreement or modification of a paediatric investigation plan (PIP)/waiver/modification

Questions and answers

Procedural advice for PIP/waiver/modification submissions. Paediatric investigation plans: questions and answers

Orphan drug designation

General information and guidance

How to apply, prevalence considerations, medical plausibility and significant benefit guidance. Applying for orphan designation

European Commission Guideline on orphan drug designation applications

PRIME scheme (PRIority MEdicines)

PRIME general information

PRIME provides enhanced support for the development of medicines that target an unmet medical need, that may offer a major therapeutic advantage over existing treatments, or benefit patients without treatment options. PRIME: priority medicines

Guidance

Innovation task force (ITF)

General information

Guidance on how to apply for an ITF briefing meeting for human or veterinary development, and information on advance therapy classification.

Mandate of the European Medicines Agency Innovation Task Force (ITF)

Qualification of novel methodologies

General Information

Scientific advice to support the qualification of innovative development methods (rather than a specific product) for a specific intended use in the context of research and development into pharmaceuticals.

Opinions and letters of support on the qualification of novel methodologies for medicine development

Guidance

SME support

SME support

Regulatory and administrative assistance by phone, email or teleconference, including SME office briefing meetings to discuss the regulatory strategy of a human or veterinary medicinal product and navigate the range of procedures and incentives. Quarterly newsletters, info days and training. Support to SMEs

User guide for SMEs

Provides an overview of procedures to support research and development activities and regulatory requirements to obtain a marketing authorisation.

User guide for micro, small and medium-sized enterprises
Applying for SME status

Includes the SME declaration form and guidance for enterprises applying for SME status before requesting financial or administrative assistance from the Agency. Applying for SME status

Opportunities to interact with EMA during the development of a medicine

Scientific advice for human medicines

Presubmission meeting for scientific advice or protocol assistance

Aim: to facilitate validation and discuss the proposed questions. Submit a meeting request to sa_submissions@ema.europa.eu approximately seven weeks in advance before the intended submission date

Paediatric development

Presubmission meeting

Aim: to ensure smooth validation. Submit your regulatory/administrative questions at least two months prior to PIP/waiver submission via the eSubmission Gateway. See also point 1.10 in regulatory Q&A. Paediatric investigation plans: questions and answers

Clarification of the PDCO requests for modification

Aim: to clarify any details of the PDCO’s requests for modification during clock-stop, contact the assigned Paediatric Coordinator. See also point 1.10 in: regulatory Q&A. Paediatric investigation plans: questions and answers

Orphan drug designation

Presubmission meeting

Aim: to ensure smooth validation. Request a presubmission meeting with an email to orphandrugs@ema.europa.eu, at least two months prior to submission of the orphan designation application

Innovation task force (ITF)

ITF briefing meeting

Send a request form to itfsecretariat@ema.europa.eu for human medicines (or vet.applications@ema.europa.eu for veterinary medicines)

Innovation Task Force (ITF) briefing meeting request form

PRIME scheme (PRIority MEdicines)

PRIME general information

PRIME provides enhanced support for the development of medicines that target an unmet medical need, that may offer a major therapeutic advantage over existing treatments, or benefit patients without treatment options. PRIME: priority medicines

Queries

Presubmission meetings are not held for PRIME. Queries prior to submission of PRIME eligibility requests can be addressed to prime@ema.europa.eu

Qualification of novel methodologies

Preparatory meeting

Request a preparatory meeting sending the joint EMA-FDA letter of intent template to qualification@ema.europa.eu

 

 

SME support

SME office briefing meeting

Aim: to discuss the regulatory strategy of a product and navigate the range of procedures and incentives available to support development and authorisation. Contact the SME office on +31 (0)88 781 8787 or sme@ema.europa.eu

From lab to patient: the journey of a centrally authorised medicine

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