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Applying for orphan designation | European …
- https://www.ema.europa.eu/en/human-regulatory/research-development/orphan-designation/applying-orphan-designation
- In particular, when completing section A.3.2 'Plausibility of the orphan condition; rationale for use of the medicinal product', sponsors should clearly identify studies with the substance in a relevant model(s) of the condition and, if possible, preliminary clinical data in patients with the condition. Each application is assigned two ...
Committee for Orphan Medicinal Products (COMP): …
- https://www.ema.europa.eu/en/documents/work-programme/comp-work-plan-2020_en.pdf
- recommendation on elements required to support the medical plausibility and the assumption of significant benefit for an orphan designation, EMEA/COMP/436/01”, taking …
Establishing medical plausibility in the context of orphan …
- https://ojrd.biomedcentral.com/articles/10.1186/s13023-014-0175-8
Establishing medical plausibility in the context of orphan …
- https://pubmed.ncbi.nlm.nih.gov/25475155/
- This requirement is commonly referred to as "medical plausibility" and the justification of this intention is assessed on the merits of each application by the COMP, …
EMEA: COMP Recommendation on elements required to support …
- https://www.sciencepharma.com/news/2000002/emea-comp-recommendation-on-elements-required,p200000024
- EMEA: Committee for Orhphan Medicinal Products Recommendation on elements required to support the medical plausibility and the assumption of significant …
Research and development | European Medicines Agency
- https://www.ema.europa.eu/en/human-regulatory/research-development
- SME support. SME office briefing meeting. Aim: to discuss the regulatory strategy of a product and navigate the range of procedures and incentives available to support …
Presentations - Orphan designation - Key concepts …
- https://www.ema.europa.eu/en/documents/presentation/presentation-orphan-designation-key-concepts-evaluation-criteria-dr-jordi-llinares_en.pdf
- Medical Plausibility. CHMP: Marketing Authorisation. COMP: Orphan Designation. Evidence of positive Benefit-Risk. Evidence of ... Reproduction and/or distribution of this …
Guideline on legal status - European Medicines Agency
- https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/guideline-legal-status-supply-patient-centrally-authorised-medicinal-products_en.pdf
- Page 5/8 ©EMEA 2006 • Medicinal product subject to restricted medical prescription, where the medicinal product: - is reserved for treatments which can only be followed in a …
Orphan designation: Overview | European …
- https://www.ema.europa.eu/en/human-regulatory/overview/orphan-designation-overview
- About 30 million people living in the European Union (EU) suffer from a rare disease. The European Medicines Agency (EMA) plays a central role in facilitating the development and authorisation of medicines …
Orphans: Regulatory and procedural guidance and forms
- https://www.ema.europa.eu/en/human-regulatory/research-development/orphan-designation/applying-designation/orphans-regulatory-procedural-guidance-forms
- SOP/H/3046. Commission Regulation (EC) No 847/2000 of 27 April 2000 laying down the provisions for implementation of the criteria for designation of a …
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