The UK Medicines and Healthcare products Regulatory Agency (MHRA) has launched an innovation office to help companies that are developing innovative healthcare products navigate the complex landscape of regulatory approval. The goal of the office is to promote dialogue between companies and the UK MRHA, particularly on when specific UK or European regulations apply or what to do in instances when regulatory guidance does not exist.
The “office” is a web portal that can be accessed via MHRA’s website. Developers of innovative products can fill out a form that will be submitted to the most appropriate person at the office. Questions can be submitted confidentially. If the question is complex and can’t be answered by email, an in-person appointment may be set up (a fee may apply). The office could be especially helpful for developers of drug-device products, tissue-engineered products and devices that incorporate nanotechnologies, according a press release and a video from MHRA (embedded below).
The announcement is the latest step in United Kingdom’s Life Science Strategy, announced in 2011. In November 2011, the UK government announced a comprehensive plan to increase patient access to new medical technologies and drugs and help medtech and pharmaceutical companies develop innovative products. The progress of implementing that plan has been slow, however. A study published in November 2012 found that many UK National Health Service providers are unaware of or unfamiliar with the plan.