Landmark endorsement of a global registry: The European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP), publicly endorses World Federation of Hemophilia Gene Therapy Registry as global standard-Reference-Cited by-同舟云学术

Landmark endorsement of a global registry: The European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP), publicly endorses World Federation of Hemophilia Gene Therapy Registry as global standard

Published:2023-12-18 Issue:1 Volume:30 Page:232-235
ISSN:1351-8216
Container-title:Haemophilia
language:en
Short-container-title:Haemophilia

Author:

Konkle Barbara A.¹^ORCID,Peyvandi Flora²^ORCID,Coffin Donna³^ORCID,Naccache Mayss³,Youttananukorn Toong³,Pierce Glenn F.³^ORCID,

Affiliation:

1. Washington Center for Bleeding Disorders University of Washington Seattle Washington USA

2. International Society on Thrombosis and Hemostasis Carrboro North Carolina USA

3. World Federation of Hemophilia Montreal Quebec Canada

Publisher

Wiley

Subject

Genetics (clinical),Hematology,General Medicine

Link

https://onlinelibrary.wiley.com/doi/pdf/10.1111/hae.14912

Reference4 articles.

1. European Medicines Agency.Letter of Support for World Federation of Hemophilia (WFH) Gene Therapy Registry (GTR).2023. Accessed 23 October 2023. (https://www.ema.europa.eu/en/documents/leaflet/letter‐support‐world‐federation‐hemophilia‐wfh‐gene‐therapy‐registry‐gtr_en.pdf)

2. World Federation of Hemophilia Gene Therapy Registry

3. European Medicines Agency.Scientific advice and protocol assistance.2023. Accessed 23 October 2023. (https://www.ema.europa.eu/en/human‐regulatory/research‐development/scientific‐advice‐protocol‐assistance:~:text=EMA%20gives%20scientific%20advice%20by advice%20on%20the%20developer's%20proposals)

4. European Medicines Agency.Qualification of novel methodologies for medicine development.2023. Accessed 23 October 2023. (https://www.ema.europa.eu/en/human‐regulatory/research‐development/scientific‐advice‐protocol‐assistance/qualification‐novel‐methodologies‐medicine‐development‐0)