Early access support

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European Network of Paediatric Research at the European Medicines Agency

Published by IRDiRC

Early Access SupportEuropean Network of Paediatric ResearchOrphan DrugPaediatric MedicineRegulatory AffairsResearch and Drug Development

The European Network of Paediatric Research at the European Medicines Agency (Enpr- EMA) is a network of research networks, investigators and centres with recognised expertise in performing clinical studies in children. Enpr-EMA enables networking and collaboration with members from within and outside the European Union (EU), including academia and the pharmaceutical industry

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JoInternationalEMA-FDA Scientific Advice

Published by IRDiRC

Early Access SupportJoInternationalEMA-FDA Scientific AdviceRegulatory SciencesScientific Advice

The European Medicines Agency (EMA) and the U.S. Food and Drug Administration (FDA) of the U.S. Department of Health and Human Services have a program to provide parallel scientific advice (PSA) to sponsors. The goal of the PSA program is to provide a mechanism for EMA assessors and FDA reviewers to concurrently exchange with sponsors their views on scientific issues during the development phase of new medicinal products (i.e., new human drugs and Biologics).

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Magisterial hospital preparations – hospital exemptions

Published by IRDiRC

Advanced TherapyATMPsEarly Access SupportHospital ExemptionRegulatory Affairs

Article 28 of the ATMP Regulation also empowers Member States to permit the manufacturing and use of certain non- routine produced advanced therapies that have not been authorised by the Commission under certain conditions (so-called “Hospital Exemption”) outside the scope of the Medicinal Product Directive 2001/23.

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Advanced Therapy Medicinal Products (ATMPs) Classification

Published by IRDiRC

Advanced TherapyATMPs ClassificationEarly Access SupportEuropean UnionRegulatory Affairs

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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Japanese Orphan Drugs/Medical Devices/Regenerative Medical Products Designation

Published by IRDiRC

Early Access SupportJ-ODDMedical ProductMHLWMHLW or PMDA RegulatoryOrphan Drug DesignationOrphan Drug or Medical Device DesignationRegulatory AffairsResearch and Drug Development

In Japan, drugs, medical devices, and regenerative medical products can be designated as orphan drugs, medical devices, or regenerative medical products based on the Article 77-2 of the Act on Securing Quality, Efficacy and Safety of Pharmaceuticals, Medical Devices, Regenerative and Cellular Therapy Products, Gene Therapy Products, and Cosmetics if they are intended for use in basically less than 50 000 patients in Japan and for which there is a high medical need.

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