Loading...
Please wait, while we are loading the content...
Similar Documents
Considering Global Development? Insights from Applications for FDA Breakthrough Therapy and EMA PRIME Designations.
| Content Provider | Europe PMC |
|---|---|
| Author | Hanaizi, Zahra Kweder, Sandra Thor, Shannon Ribeiro, Sonia Marcal, Anabela |
| Abstract | The United States Food and Drug Administration and the European Medicines Agency (EMA) each have programs to expedite development of products identified as having potential to address unmet medical needs: the Breakthrough therapy (BT) and Regenerative Medicines Advanced Therapies designation programs in the US and the Priority Medicines (PRIME) scheme at EMA. We reviewed commonalities and differences in requests submitted and products designated through these programs, with the intent to explore ways to better support global development. During the period from PRIME’s launch in April 2016 to 31 December 2020, 151 requests were made to both BT and PRIME programs and the agencies reached concordant outcomes to grant or deny requests for almost two thirds of the cases (93/151, 62%), suggesting similar perspectives across international regulators on the potential of the products under study. Forty-two (42/151, 28%) products were granted both BT and PRIME, thus found by both Agencies to have the potential to address an unmet need for a serious condition, and thereby products for which efficient development would be highly desirable. Working toward better engagement on global development strategies is in the best interests of patients and public health. With this in mind, Agencies and sponsors should take advantage of existing collaborative opportunities, such as parallel scientific advice, and work to identify fresh approaches to support global development of products for unmet medical needs. |
| Related Links | https://europepmc.org/backend/ptpmcrender.fcgi?accid=PMC9905154&blobtype=pdf |
| ISSN | 21684790 |
| Journal | Therapeutic Innovation & Regulatory Science [Ther Innov Regul Sci] |
| Volume Number | 57 |
| DOI | 10.1007/s43441-022-00475-0 |
| PubMed Central reference number | PMC9905154 |
| Issue Number | 2 |
| PubMed reference number | 36307671 |
| e-ISSN | 21684804 |
| Language | English |
| Publisher | Springer International Publishing |
| Publisher Date | 2022-10-28 |
| Publisher Place | Gewerbestrasse 11, Cham, Ch 6330, Switzerland |
| Access Restriction | Open |
| Rights License | Open AccessThis article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/. © The Author(s) 2022 |
| Subject Keyword | Drug development Regulatory EMA FDA PRIME Breakthrough |
| Content Type | Text |
| Resource Type | Article |
| Subject | Public Health, Environmental and Occupational Health Pharmacology, Toxicology and Pharmaceutics Pharmacology (medical) |
