英国药品和健康产品管理局 (MHRA) 对医疗器械临床试验的要求主要包括以下几个方面：临床试验授权 (CTA)：在英国进行医疗器械临床试验前，必须向MHRA申请并获得临床试验授权 (Clinical Trial Authorisation, CTA)。申请CTA时需要提交详细的试验计划、器械的描述和制造信息、临床前数据、风险分析、受试者信息表和同意书等。
Paragraph8 in Part 2, Schedule 7 of the Medicines for Human Use (Clinical Trials)Regulation 2004 (as amended) [SI 2004 1031] requires the manufacturing authorisationholder to keep samples of each batch of formulated products readily availablefor examination. There should be enough finished packs fo...
We will prioritise essential on-site inspections linked to the UK Government’s COVID-19 response or any other potential serious public health risk, where these sites cannot be assessed remotely. Essential clinical trial authorisation applications will not be affected by this changeand will remain pr...
as these documents do not form part of the clinical trial authorisation application. However, your report and comments on these aspects have been reviewed and considered with regard to the need for any regulatory action.
Licensing routes to obtain a marketing authorisation for a medicine in the UK, GB or NI post Brexit. Pharmavibes. Updated June 14, 2024. Accessed July 11, 2024. https://www.pharmavibes.co.uk/2024/01/13/uk-licensing-routes-post-brexit/ Guidance On International Recognition Procedure - supple...
(TMF)isthecollectionofessentialdocumentswhichallowstheconductofaclinicaltrialtobereconstructedandevaluated.Itisbasicallythestoryofhowthetrialwasconductedandmanaged.Thisbloghighlightssomeoftheissueswhichhavebeenexperiencedbysponsorsandinspectorsattemptingtomanageandreviewthelargeamountsofdocumentationthatexistinsupportofatrial....
Variations to Marketing Authorisations (MAs)https://www.gov.uk/guidance/variations-to-marketing-authorisations-mas Conversion of Community Marketing Authorisations (CAPs) to Great Britain Marketing Authorisations (MAs) - letter to industryhttps://www.gov.uk/government/publications/conversion-of-community...
The MHRA decision to approve a marketing authorisation is a national decision, which may be made through an independent assessment (national procedure), collaborative assessment (Project Orbis and ACCESS procedure) or an assessment that is reliant on the decision of the EMA (European Commission ...
The first PARP inhibitor to show clinical benefit with a new hormonal agent in first-line metastatic castration-resistant prostate cancer has been granted UK approval. The Medicines and Healthcare products Regulatory Agency (MHRA) has granted marketing authorisation for Lynparza (olaparib) as combinati...
Marketing authorisation is based on positive Phase III ELATIVE trial data6 LONDON, U.K., 8 October, 2024– Ipsen (Euronext: IPN; ADR: IPSEY) announced today that the U.K. Medicines and Healthcare products...