Drug development accelerator for rare diseases

Provided by ORPHANDEV


ORPHANDEV provides its scientific and regulatory expertise in Orphan Designation and Protocol Assistance Applications; its logistical and methodological support for clinical trials in rare diseases with a specificity in the patient’s recruitment strategy; and its experience in national and European calls for projects. This set of services and tools allows the acceleration of the development of therapies for rare diseases.

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EMA’s Innovation Task Force

Provided by European Medicines Agency


EMA provides regulatory and scientific support to foster development of new and innovative medicines, from the early phases in the laboratory all the way to the patient.

EMA achieves it through the following resources:

Innovation Task Force (https://www.ema.europa.eu/en/human-regulatory/research-development/innovation-medicines#ema’s-innovation-task-force-(itf)-section)
EU Innovation Network (https://www.ema.europa.eu/en/human-regulatory/research-development/innovation-medicines#eu-innovation-network-section) /
SME Office (https://www.ema.europa.eu/en/human-regulatory/overview/supporting-smes)
PRIME scheme (https://www.ema.europa.eu/en/human-regulatory/research-development/prime-priority-medicines)
Qualification advice on novel methodologies (https://www.ema.europa.eu/en/human-regulatory/research-development/scientific-advice-protocol-assistance/novel-methodologies-biomarkers/opinions-letters-support-qualification-novel-methodologies-medicine-development)
Scientific advice / protocol assistance (https://www.ema.europa.eu/en/human-regulatory/research-development/scientific-advice-protocol-assistance)
Post-authorisation (https://www.ema.europa.eu/en/veterinary-regulatory/post-authorisation)
Pilot for Simultaneous National Scientific Advice (SNSA): : in one single step national scientific and/or regulatory advice can be requested with two NCAs simultaneously. The focus of the SNSA is on innovative developments to identify the needs of the applicants to enhance innovation and avoid gaps in early regulatory support. The pilot aims at exploring the opportunities and interest in providing such coordinated national scientific advice particularly to developers of new medicines and therapies (https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/guidance-applicants-pilot-simultaneous-national-scientific-advice-snsa_en.pdf)

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Innovation offices in national regulatory agencies

Provided by EU Innovation Offices Network


National scientific advice for developers of medicinal products or medical devices and other technologies to optimize prospectively their development programme. • Two in one approach = get two NCA opinions within one application

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Comprehensive Inventory of available regulatory support

Provided by CSA STARS


a Comprehensive Inventory (CI) has been developed to assist European academic drug developers in finding support on regulatory affairs. The inventory lists various support services provided by national competent authorities, public actors and private entities by:
* Expertise area (ATMP, Biologicals, biomarkers, chemicals, diagnostics, drug repurposing, drug-device combinations, e/m health, ethical aspects, IVD/ Blood products, legal matters, medical devices, paediatric studies, statistics, societal aspects)
* Support activity (assistance in clinical trial application, pre-grant advice, GCP, GLP, GMP, non clinical, pre-clinical, paediatrics, Phase I, PHase II-III, Phase IV, pre-grant advice, quality)

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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. Our range of services include:

– 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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