Webb25 mars 2024 · “Metastatic triple-negative breast cancer is an aggressive and life-threatening cancer. Unfortunately, for many people with this cancer, there are not enough effective treatment options and their prognosis is extremely poor,” said Merdad Parsey, MD, PhD, Chief Medical Officer, Gilead Sciences. Webb31 dec. 2024 · The MHRA has introduced changes to national licensing procedures, including procedures to prioritise access to new medicines that will benefit patients, an …
[Withdrawn] Guidance note on new assessment routes
Webb24 okt. 2024 · If certain documents contained in your CTA application, namely the investigational medicinal product dossier (IMPD) and investigator brochure (IB), have already been reviewed and authorised by MHRA for one of your previous studies, or a study from a different sponsor, this should be highlighted in the application and a trial … Webb11 jan. 2024 · Guidance on 150-day assessment for national applications for medicines describes a new national accelerated assessment route for MAs. Under this route, the … licensing staff training record
Triennial Review of the Medicines and Healthcare Products Regulatory Agency
You can apply for a marketing authorisation (MA) for new active substances and biosimilar products or existing active substances. There are different application processes but all applications should … Visa mer If the MHRA proposes to refuse to grant the MA based on advice from CHM, there is an opportunity for the applicant to request a review of the decision. The procedure for such … Visa mer The assessment timetable for new active substances and biosimilar products or existing active substances will begin after the validation of the application. Visa mer Fees will be payable at the appropriate national rate. You can find out more about the fees we charge in the guidance MHRA fees. You can find out … Visa mer Webb7 mars 2024 · CytoDyn to File Accelerated Rolling Review with MHRA and Interim Order (IO) with Health Canada for COVID-19. U.S. FDA Reviewing Protocol for More COVID-19 Critical Patients to be Enrolled to ... WebbAccelerated assessment; Biosimilars; Compliance; Clinical data publication; Conditional marketing authorisation; Data on medicines (ISO IDMP standards) Evaluation of … licensing standards officer role