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GCP and GLP

New rules implemented

The Rules of Clinical Practice that were released for consultation on 3 September 2002 entered into operation on 19 June 2003, in accordance with Order No 266 of the Russian Ministry of Health (MoH)1,2. The rules incorporate ICH GCP guidelines into Russian drug law, as well as introducing several, stricter requirements, including:

On the same day, Rules of Laboratory Practice were also released3. These rules contain a list of requirements for planning and conducting pre-clinical studies and include technical requirements for equipment,...

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