Regulatory Science

The information proposed in this section provides key elements on the regulation of medicines for Rare Diseases in human and provides support in the:
Health Technology Assessment,
Drug repurposing,
Preclinical suties,
Early access support,
Clinical Development,
Marketing Authorization,
Ethic and legal issues,
Regulatory Agencies.

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Commission Notice 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 2022/C 440/02

Published by European Commission (EC)

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

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COMMISSION DIRECTIVE (EU) 2015/565 of 8 April 2015 amending Directive 2006/86/EC as regards certain technical requirements for the coding of human tissues and cells (Text with EEA relevance)

Published by European Commission (EC)

Technical Requirementshuman tissueshuman cells

This Comission Directive sets up measures concerning traceability requirements, notification of serious adverse reactions and events and certain technical requirements for the coding, processing, preservation, storage and distribution of human tissues and cells.

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Commission Implementing Regulation (EU) 2022/20 of 7 January 2022 laying down rules for the application of Regulation (EU) No 536/2014 of the European Parliament and of the Council as regards setting up the rules and procedures for the cooperation of the Member States in safety assessment of clinical trials (Text with EEA relevance)

Published by EC

Medicinal Productsinvestigational medicinal productsClinical Trial

EU Regulation setting up the rules and procedures for the cooperation of the Member States in safety assessment of clinical trials

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Recommendation paper on decentralised elements in clinical trials

Published by EMA

Decentralised Clinical Trials

Recommendations that aim to facilitate the conduct of decentralised clinical trials (DCTs) while safeguarding the rights and well-being of participants as well as the robustness and reliability of the data collected

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Guideline on computerised systems and electronic data in clinical trials

Published by EMA

Computerised systems, electronic data, validation, audit trail, user management, security, electronic clinical outcome assessment (eCOA), interactive response technology (IRT), case report form (CRF), electronic signatures, artificial intelligence (AI)

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Advanced Therapy Medicinal Products (ATMPs) Classification 

Published by

Regulatory AffairsEarly Access SupportAdvanced TherapyATMPs Classification

Companies can consult the European Medicines Agency (EMA) to determine whether a medicine they are developing is an advanced therapy medicinal product (ATMP). This is an opportunity for ATMP developers to receive confirmation that a medicine, which is based on genes, cells or tissues, meets the scientific criteria for defining an ATMP. The procedure can help developers to clarify the applicable regulatory framework since the beginning of the product development.

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