CHDI
European Medicines Agency issues qualification opinion that Enroll-HD can provide data and infrastructure support for post-authorization monitoring of medical products for Huntington’s disease
New York, NY, September 21, 2022; The European Medicines Agency (EMA) has issued a qualification opinion that details facets of the Enroll-HD registry, core observational study, and clinical research platform that are especially suited to post-authorization regulatory approval. Scientific advice on Enroll-HD was sought in March 2021 under a recently launched EMA initiative to facilitate the use of data from well-developed and comprehensive registries in post-authorization medical product monitoring. Importantly, the EMA opinion states that “Enroll-HD is well-suited” and “can be a source of secondary data for drug utilization studies and post-authorisation safety and efficacy studies (PASS and PAES)”; these latter studies “can also be nested in Enroll-HD” to provide primary data. Read more…