| Author (Corporate) | United Kingdom: House of Commons: Library |
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| Series Title | Briefing Paper |
| Series Details | No.8148 (24.11.17) |
| Publication Date | 24/11/2017 |
| Content Type | Journal | Series | Blog |
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This briefing paper provides an overview of existing medicines regulation in the UK and the relationship with the European Medicines Agency (EMA) and regulatory agencies in EU Member States. It considers what the options may be in this area following Brexit, and presents comment on these from stakeholders. The paper was narrowly focused on medicines regulation and did not discuss potential changes to research funding and clinical trials regulation following Brexit. Background How and when individuals and organisations in the United Kingdom get access to medicines and how their safety was ensured was one area where the UK process as a member of the EU was significantly interwoven with the work of the other Member States. The existing system while the UK was a member of the EU was that the European Medicines Agency (EMA) (based in London)* provided and coordinated licensing, expertise and support for medicines and medical devices throughout the EU. Pharmaceutical companies could choose to licence a medicine only in one EU country, but it was likely that they would opt for the centralised, or mutual recognition procedure, that allowed them to sell a product throughout the EU. The Medicines and Healthcare Product Regulatory Agency (MHRA) was the body responsible for licensing and regulating medicines and medical devices in the UK. It had worked with the EMA both as part of a regulatory network, and as a rapporteur doing a significant amount of work on behalf of the European Agency. The future for medicines regulation, and the location of the European Medicines Agency, following Brexit had been the subject of attention from the Government, pharmaceutical industry and medical organisations since June 2016. There had been calls for the Government to ensure that links with the EMA remained and concerns that leaving the EMA would result in a delay in access to innovative medicines, and a loss of investment from the life sciences sector in the UK. In contrast, it had also been suggested that leaving the EU could mean positive changes to the regulatory approach in the UK. * On 20 November 2017, the EU announced that Amsterdam would be the new location for the EMA. |
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| Source Link | Link to Main Source http://researchbriefings.files.parliament.uk/documents/CBP-8148/CBP-8148.pdf |
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| Subject Categories | Health |
| Countries / Regions | United Kingdom |
