In this section
- Adaptive pathways
- Advanced therapy medicines
- Clinical trials
- Compassionate use
- Compliance
- Data on medicines (ISO IDMP standards)
- Ethical use of animals in medicine testing
- Innovation in medicines
- Medicines for older people
- Non-pharmaceutical products
- Orphan designation: research and development
- Paediatric medicines: research and development
- Pharmacovigilance
- PRIME
- Quality by design
- Scientific advice and protocol assistance
- Scientific guidelines
- Supporting SMEs
- Support for early access
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:
- submit questions of a general nature using EMA's online enquiry form;
- consult a general overview of the main aspects of medicinal product legislation and of the European regulatory system in the User guide for micro, small and medium-sized enterprises), which is updated regularly.
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
EMA guidance on the scope and features of PRIME.
European Medicines Agency Guidance for applicants seeking access to PRIME scheme
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