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Biotechnology Regulatory Atlas, an overview of modern biotechnology regulation & how to achieve compliance

LGC : 02 April, 2003  (Company News)
The new Biotechnology Regulatory Atlas, compiled by LGC for the Department of Trade and Industry, guides SMEs and start-up companies to effective compliance strategies, equipping them to minimise the risks and costs arising from knowledge gaps. The Atlas is a key component of www.i-bio.gov.uk, the new UK Biotechnology Portal and one-stop internet resource for industry, researchers and the public interested in the biotech sector.
At the launch of i-biouk on 12 March 2003, Dr Monica Darnbrough, Director of the DTI Bioscience Unit, said: 'The i-biouk portal features the Biotechnology Regulatory Atlas, an excellent tool developed at LGC that can help with finding out about Government regulations and how they are applied right across the broad range of biotechnology.'

The Biotechnology Regulatory Atlas unfolds from the broad definition of biotechnology used by the UN Convention on Biological Diversity, meaning any technological application that uses biological systems, living organisms, or their derivatives, to make or modify products or processes for specific use. Both the Atlas and the i-biouk portal required intensive cross-governmental planning and preparatory work, pulling together government information and regulation about biotechnology into one website, a ´portal´ or doorway to biotechnology in the UK.

Dr Peter Lyne, Head of LGC´s Government Chemist Department that produced the Atlas, said: 'Although biotechnology regulations aim to protect human rights, human health, animal welfare and the environment, they are meaningless unless they are understood by biotechnologists. EU and Government regulation is on the increase, and compliance is costly for the small businesses that do so much of the exciting science. We constructed the new Biotechnology Regulatory Atlas to show how the rules and regulations fit together. Besides cross-sectoral controls on health and safety, GMOs, and intellectual property, the specialised regulations cover fields such as medicines, novel foods, human genetics and diagnostic tests. Each map explains, step by step, how to comply with a particular area of the law.'

The Atlas was scoped in conjunction with the Biotechnology Industry/Government Regulatory Advisory Group and the BioIndustry Association. LGC also co-ordinated the work of many specialists across Government to validate the component maps, liaising with the departments and executive agencies of Defra, the Department of Health, DTI, the Foods Standards Agency, the Health and Safety Executive, the Home Office, and the devolved administrations.

In recognition that companies need current regulatory information if they are to comply effectively, there will be quarterly updates to the online Atlas, and advisory services are planned around it. As the Atlas will also serve the interests of the wider stakeholder base, a watch will be kept on regulatory developments in relation to the societal context of biotechnology. Bound copies of the Atlas are available for £95 from: The Stationery Office, Marketing, TSO, FREEPOST ANG4748, Norwich NR3 1YX. Online: www.tso.co.uk/bookshop. Tel: 0870 243 0123. Fax: 0870 243 0129

The new UK Biotechnology Portal, www.i-bio.gov.uk presents biotechnology information from across government at one website. It provides swift access to accurate information on key biotechnology issues, such as scientific and policy development, industry, academic research, investment, as well as the Biotechnology Regulatory Atlas for biotech businesses. The portal uses cutting edge technology to create a single point of access to information from Government and the Research Councils and over 200 other carefully selected web sources.
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