United Kingdom submission requirements

In the development of most new active substances, it is required to investigate the disposition of the compound and its metabolite(s) and their rates and routes of elimination. This is generally carried out with radiolabelled compound, usually In the United Kingdom, approval of the Administration of Radioactive Substances Advisory Committee (ARSAC) is required for administration of radiolabelled compound to man. The purpose of the submission is to demonstrate that the dose of absorbed radiation is minimised by administration of the lowest dose that is consistent with meeting the objectives of the study. In general, the estimated absorbed radiation dose should be less than 500 xSv, but higher amoimts are permissible if they can be justified. The estimate is based on tissue distribution of radioactivity in animals and the pharmacokinetics in animals and man. 

The type of submission considered by DSEB to be appropriate for a PI update depends on the regulatory and clinical history of the drug in Australia and overseas, with special reference to the United Kingdom, United States, Sweden, Canada and the Netherlands. Submissions based on company sponsored clinical trials are usually required for drugs marketed for less than 5 years, whereas any of the three types of submission can be used for drugs marketed for more than 10 years. Drugs marketed between 5 and 10 years will be considered on a case by case basis, but it is generally expected that either a conventional or hybrid submission will be submitted. 

The Federal Food, Drug and Cosmetic Act prohibits the shipment of a new drug into interstate commerce unless there exists for that drug an approved NDA or an effective IND application. Unlike certain European countries, such as Germany and the United Kingdom, the existence of an IND is required regardless of the proposed phase of clinical trial. Thus, even phase 1 trials to be conducted in the United States on volunteer subjects require the prior submission of an IND before that trial may be undertaken. 

The editors of scientific journals, vehemently expressing their abhorrence of research and publication fraud, established the Committee on Publication Ethics (COPE) in the United Kingdom in 1997. They recommend peer review and require all named authors to sign the letter of submission, coupled with clear declarations from all parties as to conflict of interest. Such procedures would have prevented Pearce s fraud as the paper on the reimplantation of the ectopic fetus had not undergone peer review, and the co-authors were not required to detail their involvement. 

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