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ABPI updates phase 1 clinical trial guidelines

UK pharma industry body issues first new version of guidance since 2007

Guidelines for phase 1 clinical trials (2012 edition)

The Association of the British Pharmaceutical Industry (ABPI) has updated its early-stage trial guidance for the UK pharma industry.

The new version of the Guidelines for Phase 1 Clinical Trials, the first since a major revision in 2007, was created to take account of a number of regulatory changes and ensure they remain relevant for the future.

Stephen Whitehead, chief executive of the ABPI, said: “Ten to twenty years from now there will be a whole raft of innovative new medicines saving and improving patients' lives as a result of the experimental research taking place today.

“In phase 1 research, which represents the link between scientific research and clinical medicine, the highest possible level of knowledge, standards and skills must all be brought together.

“The ABPI has produced these guidelines to help support and simplify the critical role of phase 1 research, while helping researchers ensure their work is conducted with the highest possible level of efficacy and safety.”

Most of changes to the Guidelines stem from the introduction of Good Clinical Practice (GCP), Good Manufacturing Practice (GMP) and the Clinical Trials Directive, which is based on GCP and GMP.

The Guidelines also have a section on pharmacovigilance, which has this year undergone its biggest changes in seven years as a result of new European legislation.

However, another new version of the Guidelines may soon be needed. The EMA last month published proposals for simplifying clinical trial rules and cutting down on red tape. 

• The Guidelines for Phase 1 Clinical Trials can be downloaded from the ABPI website

15th August 2012

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