Designation of orphan conditions in Europe: regulatory observations and considerations after implementation of regulation 141/2000
Author:
Affiliation:
1. Orphan Office, European Medicines Agency, Amsterdam, The Netherlands
2. Orphan Medicinal Products, Sweden
3. Faculdade de Farmácia, Universidade de Lisboa, Lisboa, Portugal
4. Human Medicinal Products and INFARMED, Portugal
Publisher
Informa UK Limited
Subject
Pharmacology (medical),Health Policy,Pharmacology, Toxicology and Pharmaceutics (miscellaneous)
Link
https://www.tandfonline.com/doi/pdf/10.1080/21678707.2020.1784720
Reference15 articles.
1. Therapies for rare diseases: therapeutic modalities, progress and challenges ahead
2. Orphan medicinal products Paolo Tomasi. 2019 Sept 10.
3. Loorand-Stiver L, Cowling T, Perras C. Drugs for rare diseases: evolving trends in regulatory and health technology assessment perspectives. [cited 2019 Aug 16]. Available from: https://www.cadth.ca/drugs-rare-diseases-evolving-trends-regulatory-and-health-technology-assessment-perspectives
4. European regulation on orphan medicinal products: 10 years of experience and future perspectives
5. Recommendations for the development of rare disease drugs using the accelerated approval pathway and for qualifying biomarkers as primary endpoints
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