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Early Access SupportMHLW or PMDA RegulatoryRegulatory AdviceRegulatory AffairsScientific AdvicePMDA offers consultations to give guidance and advice on clinical trials of drugs, medical devices, and regenerative medical products as well as on data for regulatory submissions. For designated orphan drugs, PMDA offers Priority consultation.
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Early Access SupportJapanMHLW or PMDA RegulatoryOrphan DrugRegulatory AffairsSakigakeSAKIGAKE aims at shortening premarket review period for innovative new medical products that satisfy certain criteria, such as severity of intended indication, by designating such products during the early stages of development, and providing prioritized consultation services and premarket pharmaceutical affairs review.
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Early Access SupportMHLW or PMDA RegulatoryRegulatory AffairsScience Strategy ConsultationScientific AdvicePMDA provides the Pharmaceutical Affairs Consultation on R&D Strategy, mainly for universities, research institutions, and venture companies that possess promising “seed-stage” research or technologies
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Early Access SupportJ-ODDMedical ProductMHLWMHLW or PMDA RegulatoryOrphan Drug DesignationOrphan Drug or Medical Device DesignationRegulatory AffairsResearch and Drug DevelopmentIn 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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Committee for Orphan Medicinal ProductsEarly Access SupportRegulatory AffairsScientific AdviceThe EMA protocol assistance is the scientific advice of the Committee for Human Medicinal Products (CHMP) along with Committee for Orphan Medicinal Products (COMP), particularly designed for products that have orphan drug designation status.
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Early Access SupportEarly ApprovalPriority Medicines SchemeRegulatory AffairsPRIME supports developers of medicines addressing an unmet medical need or which may bring major therapeutic advantage to patient with enhanced interaction and early dialogue to optimize the development of eligible medicines, improving clinical trial designs and speed up their evaluation and contribute to timely patients’ access. PRIME builds on the existing regulatory framework and tools already available such as scientific advice and accelerated assessment.
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Early Access SupportEMA Scientific Advisory GroupRegulatory AffairsScientific AdviceSAGs can be convened by the Committee for Medicinal Products for Human Use (CHMP) to provide independent scientific expertise and advice relevant to the evaluation of medicines
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Early Access SupportNational Member State Scientific AdviceNational Scientific AdviceRegulatory AffairsScientific AdviceProcedures set up by many (but not all) National Member State to offer scientific advice to developers of new medicines. The procedures can be similar but often less formal than for CHMP scientific advice/protocol assistance at the EMA; they may include written advice and/or face-to-face meetings. The procedures are not limited only to orphan product development and may vary between Member States.
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Early Access SupportOrphan Drug DesignationRegulatory AffairsEU orphan legislation offers important incentives to encourage the development of medicinal products for rare diseases and the success of the legislation has been demonstrate
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Early Access SupportEarly Stage AdviceEMA Innovation Task ForceRegulatory AffairsScientific AdviceThe ITF is a multidisciplinary EMA group that includes scientific, regulatory and legal competences. It was set up to ensure coordination across the Agency and to provide a forum for early dialogue with applicants on innovative aspects in medicines development. Area of interest: innovative therapeutics and techniques, innovative development methods, borderline products.
From the first request by the applicant, the procedure lasts approximately 8-10 weeks (ITF Secretariats confirms eligibility criteria approx. within 2 weeks; when confirmed, then approx. 2 weeks about experts’ involvement + meeting date after 4-6 weeks).
