The regulation of medicines, and the overall responsibilities of the MHRA, involves considerably more than a "once only" marketing authorization. Regulation also entails post-licensing surveillance of safety and scrutiny of any proposed variation to the clinical indications for the medicine, any changes...
Last month the Medicines and Healthcare products Regulatory Agency (the “MHRA”) launched apublic consultationon the future of medical device regulation in the UK (the “Consultation”). This consultation comes approximately a month after theReport on Medical Devices(the “Re...
The regulator for medicines and medical devices (the Medicines and Healthcare Products Regulatory Agency) announceda regulatory sandbox called the “AI-Airlock” to promote the development and deployment of AI software and medical devices in a monitored envi...
European medicines agencyEuropean tissue and cell directivegene therapy productshospital use exemptionstem cell regulationUKEU law largely prescribes the framework of regenerative medicine in the Member States of the European Union. It either applies directly, as in the case of a Regulation, or, in ...
In these sometimes nebulous areas, medicines regulations, codes of practice and the like have been invaluable in maintaining public confidence (in both their medicines and their doctors) and allowing the industry to remain independent and retain well respected relationships with other groups. These two...
Check whether or not (contractual) delegation of powers and obligations within the supply chain complies with the MDR – eg delegation of regulatory checks imposed on a local distributor to another group company. For manufacturers: have clauses in place to obtain mandatory ...
2 Asklepieion Consultancy Ltd., Herts, UK 3 British Pharmaceutical Industry, London, UK 4 Medicines Division, DOH, London (now MHRA), UK Author Information Centre for Socio-Legal Studies, University of Oxford, Oxford, UK Publication History Published Online: 18 NOV 2009 Published Print: 13 NOV...
According to a late-February posting on the website of Medical Design & Outsourcing, the UK’s Medicines and Medical Devices Act of 2021 was passed to address the regulatory gap for medical devices created when the UK officially left the European Union (EU) in January 2021. Until then, medi...
Telephone 020 7084 2000 (weekdays 0900 -1700), 020 7210 3000 (other times), Fax 020 7084 2353, E-mail info@mhra.gsi.gov.uk, Website 被引量: 1发表: 0年 Regulation of medicines in China Over the past decade, China has introduced significant changes to the regulation of medicines through...
Dopamine (DA) regulates reproductive behavior and promotes maturation of the reproductive system in insects. In Drosophila, male courtship behavior is regulated by the protocerebral posteriolateral dopaminergic cluster neuron 2ab (PPL2ab). The ability to synthesize DA in the PPL2ab affects male-male...