In December 2004 the Department of Health’s Ministerial Industry Strategy Group (MISG) agreed to develop a long term strategy for medicines. The objectives of this strategy were to continue to secure the provision of safe and effective medicines for patients, whilst maintaining and strengthening the UK pharmaceuticals industry within Europe, and to advance healthcare innovation with the NHS.
In February 2006, as part of the development of this long term strategy, the MISG agreed to establish a Panel and a Forum, jointly sponsored by the MHRA and the Association of the British Pharmaceutical Industry (ABPI), to discuss future challenges in the regulation of pharmaceuticals. It is intended that the Forum will meet twice a year, to discuss scientific developments and topics that may have a significant future impact upon the regulation of pharmaceutical development and/or registration, for the purpose of ensuring that the relevant UK regulatory authorities are aware and ready to meet predictable new directions and challenges.
The ultimate aim of the Forum is to assist in bringing about improvements to public health in the UK, by ensuring that early stage pharmaceutical research can utilise the latest technology available to deliver medicines that are needed by patients and prescribers, to ensure that regulatory requirements and guidelines take account of scientific developments, and industry has a clear understanding of the likely regulatory requirements in areas of scientific developments.
An Advisory Panel has been established to identify suitable topics for the Forum that have the potential to challenge the current regulation of pharmaceuticals in the UK. The Advisory Panel will consider referring any such topics to relevant pre-existing bodies, or decide to hold a Forum meeting on the topic. The Panel will identify and prioritise topics for Forum discussion. The Panel will organise Forum meetings, draft any proposed action plans, and, if appropriate, make recommendations for any future regulatory framework to facilitate the development of medicinal products. Such recommendations could also assist industry by outlining the type of data that might be required for the future development of the product.
The composition of the Panel includes industry, regulators, representatives of the clinical academic community and a lay representative. The Forum consists of panel members together with additional experts in the specific topic to be discussed. Minutes of the Panel and Forum meetings will be published, together with any recommendations made:
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Minutes of the Ministerial Industry Strategy Group (MISG) New Technologies Advisory Panel
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