Research and development

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.

For more information, see: 

• Scientific advice and protocol assistance

Procedural advice for requesting scientific advice and protocol assistance. 

For more information, see:

• Requesting scientific advice or protocol assistance from EMA

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

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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. 

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

For more information, see: 

• Paediatric investigation plans

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

Procedural advice for PIP/waiver/modification submissions.

For more information, see:

• Paediatric investigation plans: questions and answers

How to apply, prevalence considerations, medical plausibility and significant benefit guidance.

For more information, see:

• Applying for orphan designation

For more information, see:

• Guideline on the format and content of applications for designation as orphan medicinal products and on the transfer of designations from one sponsor to another

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.

For more information, see:

• PRIME: priority medicines

EMA guidance on the scope and features of PRIME.

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

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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.

For more information, see:

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

Procedural advice.

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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.

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• Support to SMEs

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

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

For more information, see:

• Applying for SME status

Aim: to facilitate validation and discuss the proposed questions. It's possible to request a meeting when submitting an application for scientific advice and protocol assistance via IRIS.

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

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.

For more information, see:

• Paediatric investigation plans: questions and answers

Aim: to ensure smooth validation. Request a pre-submission meeting via the IRIS portal, at least two months prior to submission of the orphan designation application

Send a request form to [email protected] for human medicines (or [email protected] for veterinary medicines)

For more information, see:

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.

For more information, see:

• PRIME: priority medicines

EMA offers pre-submission support to any applicant planning a PRIME application, including a virtual pre-submission meeting to discuss PRIME eligibility. Applicants can submit these requests via IRIS.

Queries prior to submission of PRIME eligibility requests can be sent to [email protected].eu.

Request a preparatory meeting when submitting an application for Qualification via IRIS.

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 [email protected]