Ian Hudson, MHRAThe Medicines and Healthcare products Regulatory Agency (MHRA) will be changing from 1 April 2013. Dr Ian Hudson, Director of the Licensing Division at MHRA explains more.

As of 1 April 2013, the National Institute for Biological Standards and Control (NIBSC) will be moving from being a centre of the Health Protection Agency to join the MHRA. We believe that this is an excellent move for both NIBSC and the MHRA, and it coincides with the Health Protection Agency being replaced by a new organisation, Public Health England, with broader responsibilities to deliver public health improvement as well as protection.

From April, the new MHRA will comprise three centres:

  • MHRA Regulatory – focused on the core activities of product licensing, inspection and enforcement, and pharmacovigilance
  • The Clinical Practice Research Data link (CPRD) – which gives access to an unparalleled resource for conducting observational research and improving the efficiency of interventional research across all areas of health, medicines and devices. CPRD joined the MHRA in 2012.
  • The National Institute for Biological Standards and Control

NIBSC’s statutory functions in support of standardisation of control of biological medicines will be unchanged. It will retain its identity, operating from its existing facilities and continuing to carry out its three key activities:

  • Development of international standards and reference materials in collaboration with WHO
  • Testing of biological medicines as the UK’s Official Medicine Control Laboratory
  • Conducting research related to standardisation and control of biologics

Our stakeholders, customers and collaborators can be assured that existing relationships will not be adversely affected by this change. Indeed we anticipate that in many areas they will be considerably strengthened.

The enlarged Agency will have some 1200 staff and through the addition of NIBSC, will have unique expertise in biologics with 350 regulatory and scientific staff covering the complete spectrum of biological medicines. It will also have greater reach and influence through the combined links of its component parts, and this, together with its scientific depth, will strengthen its ability to support manufacturers, help shape rational and proportionate regulation, and facilitate innovative research and development.

Additionally on 11 March 2013, the MHRA launched 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.

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 Strategy for UK Life Sciences launched by the Prime Minister 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.

At the MHRA we look forward to continuing to work with our stakeholders as the new organisation develops. If you have any queries, please get in touch with the MHRA.