§ Mr. Pavittasked the Secretary of State for Social Services what percentage of the medicines submitted for approval by the Committee on Safety of Drugs were reformulations or mixtures of established drugs during the years 1969 and 1970; what was the actual number of drugs falling within this description which re- 254W ceived approval; and if he will make a statement.
§ Mr. Alison90.6 per cent. in 1969 and 88.4 per cent. in 1970; of the reformulations and mixtures of established drugs submitted in those years, 633 were approved in 1969 and 425 in 1970. Of those which did not receive approval in 1969, 31 were rejected by the Committee, 29 withdrawn by the applicant, and 75 could not be proceeded with, generally because, in spite of requests for additional information, the evidence provided was inadequate.
In 1970, 55 were rejected, 21 withdrawn and 88 could not be proceeded with or had still to be considered.
§ Mr. Pavittasked the Secretary of State for Social Services what was the total number of adverse reactions to new drugs reported to the Committee on Safety of Drugs during 1969 and 1970.
§ Mr. AlisonDuring 1969 and 1970 the Committee on Safety of Drugs received 792 reports of adverse effects associated (by those who reported them) with medicinal products containing an active constituent not previously used in the United Kingdom, the marketing of which was agreed by the Committee during the period 1967 to 1970.