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I think that any unscrupulous deviant manufacturer etc. can set up a company to do anything anywhere they wish especially if the place has laxed regulations and the like and money and connections remains the lubricant via which the wheels of commerce spin. The real issue is the regulations in the nation where the product is to return. For example as I think of this question by Amy, if a manufacturer of a drug lets say outside of Canada is selling product in Canada, or even has offices in Canada, then the off site manufacturer has to be inspected and meet GMP and GCP type regulatory requirements. So if a malevolent type act is taking place off site , the question to me really is would the product be subject to the rules and laws of the nation that has a present injunction, when it makes it journey into that place. and how can you track it to source. Best, Paul E. Alexander --- On Thu, 5/3/12, Dreaves, Hilary <[log in to unmask]> wrote: From: Dreaves, Hilary <[log in to unmask]> Subject: Re: UK equivalent of FDA To: [log in to unmask] Received: Thursday, May 3, 2012, 9:42 AM Hi, From my limited practical experience of working with some dependencies, they are not be under UK law day to day, unless a large (perhaps unfortunate) event/happening arises that means it is then brought into greater effect/fallen back on. Similarly with EU, they may choose to (and do) use EU legislation/policy as guidance/ good practice/evidence, but they are not bound by it. Hilary Dreaves Research Fellow (HIA) IMPACT International Health Impact Consortium Department of Public Health and Policy Institute of Psychology, Health and Society University of Liverpool Liverpool 3GB Tel: +44(0)151-794 5004 (office) Email: [log in to unmask] Website: www.healthimpactassesment.co.uk 2009 winner Research Councils UK Knowledge Transfer award for Public Policy and Service Impact www.liv.ac.uk/news/features/impacts-award.htm From: Evidence based health (EBH) [mailto:[log in to unmask]] On Behalf Of vijaya madhavan Sent: 03 May 2012 09:28 To: [log in to unmask] Subject: Re: UK equivalent of FDA Amy As far as I know the MHRA is affilitated to the corresponding EU body that includes the national regulator for all the member EU countries. Most of the British dependencies are not part of the EU. may explain For eg the Isle of Man and Jersey and other Channel Islands are not part of the EU. That may explain the issue you are dealing with. Vijaya On 3 May 2012 09:10, Fiona Morgan <[log in to unmask]> wrote: The UK regulatory body is the Medicines and Healthcare Products Regulatory Agency (MHRA). http://www.mhra.gov.uk/ That being said, I suspect it's unlikely to get directly involved in matters outside the UK and I'm not sure whether it would have the jurisdiction to do so. The Cayman Islands has it's own government which includes a ministry of Health, Environment, Youth, Sports and Culture http://www.ministryofhealth.gov.ky/ Best wishes Fiona Morgan [log in to unmask] Support Unit for Research Evidence Cardiff University Neuadd Meirionnydd 1st Floor Heath Park Cardiff CF14 4YS Tel: 029 20 687926 Lecturer, Operating Department Practice School of Healthcare Studies Ty Dewi Sant Room 4.1 Heath Park Cardiff CF14 4XN Tel: 029 20 687721 From: Amy Price <[log in to unmask]> To: [log in to unmask] Date: 03/05/2012 00:11 Subject: UK equivalent of FDA Sent by: "Evidence based health (EBH)" <[log in to unmask]> Hi all I am wondering if the UK has an equivalent regulatory agency to the FDA in USA and if so would the regulation extend to British territories such as the Cayman Islands? There are stem cell clinics who were culturing cells that have an injunction against them in the USA by FDA and now they are opening shop in the Cayman Islands. Who if anyone regulates this? Best, Amy