Company Overview of Medicines and Healthcare products Regulatory Agency
10-2 Market Towers1 Nine Elms Lane
London, SW8 5NQ
Key Executives for Medicines and Healthcare products Regulatory Agency
Compensation as of Fiscal Year 2013.
Medicines and Healthcare products Regulatory Agency Key Developments
Medicines and Healthcare Products Regulatory Agency Supports the Classification of Woulgan® Biogel of Biotec Betaglucans as Medical Device Class III Under Rule 13
Oct 28 13
The Medicines and Healthcare products Regulatory Authority (MHRA) has announced Biotec BetaGlucans that it supports the classification of Woulgan® Biogel as a medical device class III under rule 13. Biotec BetaGlucans in July 2012 submitted an application to have Woulgan® Biogel classified as a medical device in class III under rule 13 in the EU Directive for Medical Devices. This is a classification for medical devices with a secondary, ancillary medicinal effect. Woulgan® Biogel contains Biotec BetaGlucans' proprietary beta-glucan SBG which has such a medicinal effect. This requires the approval of an authorised medical authority, which in this case has been the MHRA in the UK. Classification and approval of medical devices with ancillary medicinal effects are complicated processes. The MHRA has therefore consulted medical authorities in other countries with respect to the classification of Woulgan® Biogel. This has led to delays in the approval process. These consultations have now been finalised, and based on the documentation Biotec BetaGlucans has submitted- the MHRA has concluded that Woulgan® Biogel satisfies the requirements for classification as a class III medical device under rule 13. Although certain process- and quality-related questions need answering before the MHRA can complete its final approval of the application, the company believes that this decision significantly reduces the risk related to the approval process. Some work also remains with respect to certification from Presafe, which is the designated Notified Body responsible for the CE-marking of Woulgan® Biogel. The company does not expect this to generate any significant problems for the application.
Department of Health Names Three New Non-Executive Directors to the Board of the Medicines and Healthcare Products Regulatory Agency
Jul 26 13
Department Of Health has announced that three new Non-Executive Directors will join the board of the Medicines and Healthcare products Regulatory Agency (MHRA). The three Non-Executive Directors are: Dame Valerie Beral, Director of the Cancer Epidemiology Unit at the University of Oxford; Professor Alexander Markham, Professor of Medicine at the University of Leeds and; Professor David Webb, Christison Professor of Therapeutics and Clinical Pharmacology at the University of Edinburgh.
Medicines and Healthcare Products Regulatory Agency Announces Executive Changes
Jul 5 13
Medicines and Healthcare products Regulatory Agency announced the appointment of Dr. Ian Hudson as its Chief Executive. He will take up the post in September when current Chief Executive Sir Kent Woods steps down, after ten years with the agency. Dr. Hudson is currently the MHRA's Licensing Director, responsible for the majority of medicines licensing activities. He is the UK delegate to the Committee on Human Medicinal Products (CHMP) at the European Medicines Agency and has been its vice-chairman since October 2012.
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