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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INTEGRATED ADDENDUM TO ICH E6(R1): GUIDELINE FOR GOOD CLINICAL PRACTICE E6(R2)

Published by International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH)

Internatonal Council for Harmonisation (ICH)Regulatory Authorities

The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) brings together the medicines regulatory authorities and pharmaceutical industry around the world.

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EMA Scientific guidelines

Published by

Clinical DevelopmentClinical Trial DesignGuidelineRegulatory AdviceRegulatory Affairs

The European Medicines Agency’s Committee for Medicinal Products for Human Use prepares scientific guidelines in consultation with regulatory authorities in the European Union (EU) Member States, to help applicants prepare marketing authorisation applications for human medicines. Guidelines reflect a harmonised approach of the EU Member States and the Agency on how to interpret and apply the requirements for the demonstration of quality, safety and efficacy set out in the Community directives.

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European Paediatric Translational Research Infrastructure (EPTRI)

Published by EPTRI

Drug DevelopmentpaediatricRegulatory Affairsresearch infrastructureTranslational Research

The EPTRI Centralised Services are provided by the EPTRI CMO and dedicated experts. These services include:
*Providing access to paediatric patients’ cohorts
*Providing access to paediatric samples and related data
*Advice on in-vivo / in-silico non-clinical study design
*Advice on in-vivo / in-silico clinical study design
*Advice and document preparation for regulatory and ethics procedures
*Advice on preparing HTA reports for paediatric medicines, diagnostics, and medical devices
*Advice on data and sample sharing preparation
*Support with applications to public and private funding opportunities

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UNESCO. International Declaration on Human Genetic Data, 2003.

Published by Unesco

Genetic DataUNESCO

The purpose of the Declaration is to ensure the respect of human dignity and protection ofhuman  rights  and  fundamental  freedoms  in  the  collection, processing, use  and  storage  ofhuman genetic data, in keeping with the requirements of equality, justice and solidarity

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Secretariat of the Convention on Biological Diversity. Nagoya Protocol On Access To Genetic Resources And The Fair And Equitable Sharing Of Benefits Arising From Their Utilization To The Convention On Biological Diversity. Canada, 2011. ISBN: 92-9225-306-9.

Published by United Nations

Genetic ResourcesNagoya ProtocolTranslational Research

The Protocol  provides
a strong basis for greater legal certainty and transparency for both providers
and users of genetic resources. It also promotes the use of genetic resources and associated traditional knowledge,  strengthens the opportunities for fair and equitable sharing of benefits from their use. 

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