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By John Griffin, John O'Grady
A concise yet accomplished textual content explaining the tactics curious about legislation of gear with specific emphasis on european, united states and Australia.
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11 Conclusions This chapter has provided, hopefully, a brief but interesting account of the events that have been responsible for the evolution of the present drug controls in the UK. Importantly, it highlights how the broad pattern of drug regulation was already set during the early period that led to the implementation of the Medicines Act in 1971 and how this pattern was consolidated during the decade thereafter. Contrary to what is generally believed, the need for an effective control was always recognised, and indeed demanded, and there was a sort of control.
The CRM was deemed to have completed its work in 1991 and was disestablished on 31 March 1992 (SI 1992/606) while similarly, the CDSM was disestablished on 31 December 1994 (SI 1994/15). During their existence, the CRM and the CDSM had four chairmen each – Professors EF Scowen (October 1975–December 1978), OL Wade (January 1979–December 1984), W Asscher (January 1985–December 1986) and DH Lawson (January 1987–March 1992) chairing the CRM, while Professors RA Cawson (October 1976–December 1979), R Hurley (January 1980–December 1981), CL Berry (later Sir Colin Berry, January 1982–December 1992), and D Poswillo (January 1993–December 1994) chaired the CDSM.
The Licensing Authority did not lay down rigid requirements concerning the data that must be provided before authorisation can be given for a certificate for the clinical trial of a new drug. It did, however, issue guidelines for applicants. In view of the regulatory delay that was caused by the need to apply for a CTC, a Statutory Order (SI 1974/498) was made during 1974 to provide an exemption from the need to hold a CTC in such cases, subject to certain conditions (this order applied to trials conducted by doctors and dentists on their own responsibility (DDX)).