|Date:||11 March 2013|
|Contact:||Press Office 020 3080 7651
Out-of-hours 07770 446 189
The MHRA is launching an ‘Innovation Office’ to help organisations who are developing innovative medicines, medical devices or using novel manufacturing processes to navigate the regulatory processes in order to be able to progress their products or technologies.
The main aim of the ‘Innovation Office’ will be to promote early dialogue between innovative organisations and the MHRA to help facilitate their understanding of the regulatory considerations applicable to their innovation. For example the MHRA can advise on the development of innovative products like advanced therapies, nanomedicines and drug device combinations.
The ‘office’ will be a web-based portal accessed via the MHRA website. Developers of such technologies will be able to fill in a simple form which will be submitted confidentially to the most appropriate person at the MHRA.
MHRA Director of Licensing, Dr Ian Hudson said:
“We’re looking forward to providing advice and assistance to companies who are developing innovative products or exploring innovative approaches.
“Developers of novel technologies or products are often unsure which UK or European regulations apply and we hope that our ‘Innovation Office’ will give them the help they need to understand the regulatory requirements and pathway for progressing their novel product or approach.
“This initiative has been developed as part of the Life Sciences Strategy launched in 2011 to help create incentives for organisations wishing to promote healthcare innovation. The ‘office’ will help to encourage the growth of the life sciences industry.”
Notes to Editor1.Please see link to the MHRA’s innovation page: Innovation
2. There will be no fee for contacting the Innovation Office, though there could be a fee for subsequent meetings.
3. The MHRA is the government agency responsible for ensuring that medicines and medical devices work, and are acceptably safe. No product is risk-free. Underpinning all our work lie robust and fact-based judgements to ensure that the benefits to patients and the public justify the risks. We keep watch over medicines and devices, and take any necessary action to protect the public promptly if there is a problem. We encourage everyone – the public and healthcare professionals as well as the industry – to tell us about any problems with a medicine or medical device, so that we can investigate and take any necessary action.