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UK Regulator Touts its Involvement in Domestic Manufacturing Site

Posted 26 March 2015 | By Michael Mezher 

UK Regulator Touts its Involvement in Domestic Manufacturing Site

The UK's Medicines and Healthcare Products Regulatory Agency (MHRA) is once again touting its efforts to bolster manufacturing innovation, releasing a case study explaining its role in the redevelopment of a local manufacturing site.


In 2013, MHRA launched its Innovation Office, with the goal to provide advice and assistance to companies working on novel treatments or manufacturing processes. The Innovation Office encourages companies to contact them early in the development process for innovative products, and says that its questions and answer will remain confidential.

To date, the Innovation Office has published five case studies on its activities, which have ranged from providing advice on facility design to novel vaccine development.

Case Study

In its most recent case study, released on 26 March 2015, MHRA says it was approached by combination products manufacturer BTG plc after the company decided to repurpose an existing medical device facility to accommodate production of a new drug-device combination product, Varithena, a minimally invasive treatment for varicose veins.

The company's plan was complicated by several factors, MHRA recounted. The site had to be redesigned to accommodate both drug and device production, and BTG faced time constraints in its effort to get the site up and running and compliance with UK manufacturing regulations.

To address those challenges, BTG reached out to MHRA for assistance. MHRA said it was able to help in four ways:

  • responding quickly to an early request for engagement in the project
  • reviewing early plans and advising on regulatory requirements
  • acting as a sounding-board to help BTG make the right decisions at the right time
  • helping BTG to mitigate risk and overcome challenges

With the help of MHRA’s input, BTG completed the site in 2014, and is working to make its product available in global markets.

MHRA says the site will contribute to the local economy, as it brought in an additional 50 jobs and required an investment of £4 million to be completed.


MHRA Case Study

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