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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Assessment of the EU Member States’ rules on health data in the light of GDPR

Published by European Union

General Data Protection RegulationGPDR

The results of this study allow for a detailed assessment of possible elements at Member States/EU level that might affect the movement of health data across borders. It also identifies practices that could facilitate this exchange of data, as well as possible policy options for strategies in this area

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Qualification of novel methodologies for drug development: guidance to applicants (EMA/CHMP/SAWP/72894/2008). 2013

Published by EMA

Drug DevelopmentEMA Qualification

The EMA Qualification process is a new, voluntary, scientific pathway leading to either a CHMP Qualification opinion or a qualification advice on innovative methods or drug development tools

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REGULATION (EC) No 1394/2007 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 13 November 2007 on advanced therapy medicinal products and amending Directive 2001/83/EC and Regulation (EC) No 726/2003

Published by EC

Advanced TherapyMarketing Authorisation

This Regulation lays down specific rules concerning the authorisation, supervision and pharmacovigilance of advanced therapy medicinal products.

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ICH E6 (R3)Good clinical practice

Published by EMA

clinical study/trial reportClinical TrialsdecentraliseddesignEthics CommitteeGood Clinical Practice (GCP)ICH E6(R3)Informed ConsentInnovationinvestigatorinvestigator's brochurepragmaticprotocolreal-worldsafety reportingSponsorstatisticsTrial Design

The ICH guideline for good clinical practice (GCP) establishes an international standard for the design, conduct, recording, and reporting of clinical trials involving human participants. It outlines the responsibilities of sponsors, investigators, and other stakeholders to protect the rights, safety, and well-being of trial participants, while ensuring the integrity and credibility of clinical trial data.
The guideline provides a unified framework to facilitate the mutual acceptance of clinical trial results by regulatory authorities across ICH member regions, supporting global collaboration in drug development and ensuring consistent regulatory standards.?

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EATRIS Regulatory support

Published by n/a

EATRISOrphan Drug DesignationRegulatory SupportScientic advice

Through a combination of in-house and external partnerships with a range of regulatory experts and groups, EATRIS can provide regulatory support for most types of product including: Expert opinion, Orphan Drug Designation and Scientific Advice application at the EMA, Pre-clinical and clinical plan development, Informal scientific advice with selected national competent authorities, for highly complex projects,
access to EATRIS Regulatory Database (free of charge) that contains information about the regulatory requirements, guidelines and legislations from 27 EU countries (as well as Norway, Switzerland, Turkey and Israel) regarding drug and medical device development derived from the application of European legislation.

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Regulatory and Ethical Database (RED)

Published by ECRIN

RED is a central resource for information about clinical trial regulatory and ethical requirements covering 22 European countries and multiple study types such as clinical drug trials, clinical investigations of medical devices, combination drug-device studies and nutritional studies.

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Rare diseases, orphan drugs, and their regulation in Asia: Current status and future perspectives

Published by IACMHR Co., Ltd.

Orphan DrugRegulatory Science

This paper describes the current status of the regulation of rare diseases and orphan drugs in Asia and we comparatively analyze the regulation of rare diseases and orphan drugs worldwide in order to examine the challenges to and future perspectives on promoting research on rare diseases and development of orphan drugs in China and other Asian countries.

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