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HomeStudy on the regulation of advanced therapies in selected jurisdictions
Final report
Väljaande metaandmed
This study concerns advanced therapies, which can be briefly defined as innovative medical products for human use based on genes, cells and tissues. The scope of the study includes the current regulatory framework in force for advanced therapies in four selected jurisdictions: United States (US), Canada, Japan, and South Korea. The analysis includes new provisions that have been adopted but have not yet entered into force. Key aspects in the study were predetermined and include the scope of advanced therapy regulation, regulation for clinical trials, marketing authorisation, manufacturing and quality requirements, post-marketing requirements, and regulatory pathways to gain access to advanced therapy treatment outside of clinical trials and to marketed products. In addition, the study includes an overview of research activities and availability of advanced therapies and an analysis of economic aspects of the advanced therapies market in the four jurisdictions. The economic aspects discussed include relevant intellectual property rights (IPR) legislation; incentives to support developers of advanced therapies; the average approval procedure time and time to be commercialised after approval of selected products; and a quick scan on pricing and reimbursement policies that exist in each of the jurisdictions. Data were collected through desk research of regulatory and other relevant documents by an extensive literature search in peer-reviewed (e.g. PubMed, Web of Science) and clinical trial databases (data lock point: 31 December 2014), and from interviews with relevant regulatory bodies and other key stakeholders in each jurisdiction. After the initial data collection period, follow up surveys were sent out to all relevant stakeholder groups in order to verify findings and to collect additional information.
- Avaldatud:
- Teemad: Meditsiinialased ja bioloogilised uuringud , Farmaatsia- ja kosmeetikatööstus
- Teema: farmaatsiatööstus , intellektuaalomand , katsetamine , ravi , ravim , ravimiseadusandlus , ravimpreparaat , standardite ühtlustamine , tervisekindlustus , tervishoid , tervishoiuseadusandlus , turundus
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| ISSN | ISBN 978-92-9200-731-7 | DOI 10.2818/74841 | Katalooginumber EB-04-16-602-EN-N |
- Released on EU publications website:
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