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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  2. Regulatory Science
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European Medicines Agency. Guideline on registry-based studies. Committee for Human Medicinal Products (CHMP). EMA/426390/2021

Published by European Medicines Agency

Feasibility AnalysisHuman Medicinal ProductsPatient RegistryReal Word DataReal World EvidenceRegistry-Based Study

The objective of this Guideline is to provide recommendations on key methodological aspects that are
specific to the use of patient registries by marketing authorisation applicants and holders (MAAs/MAHs)
planning to conduct registry-based studies

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DIRECTIVE 2001/20/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 4 April 2001

Published by Official Journal of the European Communities

Clinical TrialsGood Clinical Practice (GCP)

This Directive establishes specific provisions regarding the conduct of clinical trials, including multi-centre trials, on human subjects involving medicinal products as defined in Article 1 of Directive 65/65/EEC, in particular relating to the implementation of good clinical practice. This Directive does not apply to non-interventional trials.

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World Medical Association Declaration of Helsinki Ethical Principles for Medical Research Involving Human Subjects

Published by JAMA

EthicsHuman SubjectsResearch

The World Medical Association (WMA) has developed the Declaration of Helsinki as a statement of ethical principles for medical research involving human subjects, including research on identifiable human material and data.

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