§ Mr. Ashleyasked the Secretary of State for Social Services how many applications for product licences for new drugs have been made in each of the past five years; how many have been accepted or rejected; and how many are now under consideration.
Number of applications outstanding at 30 November 1982–905 Number of applications received for new drug substances (NDS) Number of applications received for product licences (PLs)for these substances Number of applications withdrawn/rejected Number of product licences granted N.D.S. PLs N.D.S. Products 1978 41 79 — — 26 51 1979 34 102 4 4 26 46 1980 37 81 8 11 27 47 1981 23 146 8 11 36 66 1982* 42 78 9 15 26 45 * To end of October. Number of applications for new drug substances outstanding at 31 October 1982=52.
Number of applications for product licences for these substances outstanding at 31 October 1982=78.
Note:
The number of applications for product licences for new drug substances is greater than the number of new drug substances because separate product licences are required for different strengths of a product.