§ Mr. Ashleyasked the Scretary of State for Social Services, pursuant to his reply of 9 December, Official Report,c. 586, whether there are currently any research studies investigating the incidence or severity of the adverse effects of drugs; how many such studies have received Government financial support; and whether any requests for Government financial support for such projects have been rejected.
§ Mr. Geoffrey FinsbergThe Department is currently providing support from its research funds for the following three projects concerned with adverse drug reactions.
686W
§ Mr. Geoffrey FinsbergDetails of the new medicinal products including new drug substances for which product licences applications have been processed over the past five years are as follows:
New Product Licences (including new drug substances) Number of applications received Number of applications withdrawn/rejected Number of product licences granted 1978 835 212 597 1979 922 352 608 1980 1,180 372 604 1981 1,043 408 765 1982* 1,188 365 896 * To end of November. (1) University of Southampton:
Prescription event monitoring(2) University of Dundee:
Comprehensive drug monitoring(3) University of Liverpool/Mersey regional health authority:
Investigation of the role of locally produced drug information on the safe, rational and economical use of drugs.One request for support of a project in this field was rejected in 1981.
I understand that the Medical Research Council is supporting some research in this field from its grant-in-aid under the science budget from the Department of Education and Science.
§ Mr. Ashleyasked the Secretary of State for Social Services to what extent and in what way the Committee on Safety of Medicines monitors research studies presented with applications for product licences.
§ Mr. Geoffrey FinsbergThe Committee on Safety of Medicines monitors research studies presented with applications for product licences by considering the protocols, reported conduct and results of the studies, and, where necessary, seeks further information from the applicant on the conduct or outcome of the studies.