United Kingdom Reaction Reporting Scheme

The Suspected Adverse Reactions Reporting Scheme - United Kingdom... 

Where a clinical trial was proposed with a marketed product then the CTMP scheme could be used. This was a streamlined process based on the fact that there were no quality issues with a product that had already been granted a marketing authorisation. The applicant submitted a copy of the trial protocol, provided information on the investigators and, depending on whether or not the applicant was the MAH, information on the procedures for reporting adverse drug reactions. It was only possible to use this procedure for UK marketed products. It did not apply to unauthorised products manufactured specifically for trial or to products, which were licensed only in countries other than the United Kingdom. 

The spontaneous adverse reaction reporting system in the United Kingdom is based on the submission of ADR reports by doctors and dentists by means of reply-paid yellow cards . The system was introduced in 1964 by Professor Witts, the first chairman of the Adverse Reactions Subcommittee of the original Committee on Safety of Drugs (CSD). The system has continued unchanged to the present time, and the number of reports and fatal reactions each year of the scheme s operation is shown in Table 33.3. 

Lane, A. M., and R. G. Thomas The Theory of Nuclear Reactions and the Compound Nucleus. Rev. Mod. Phys. to be published in 1957. — A very full treatment of the dispersion theory of nuclear reactions, particularly valuable for its treatment of reaction constants in various coupling schemes. Comparison with experimental information is made also Lane, A. M. The reduced widths of nuclear energy levels, A.E.R.E. Report T/R1289 (1954). (United Kingdom Atomic Energy Authority.)... 

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