§ Sir Michael McNair-WilsonTo ask the Secretary of State for Health whether erythropoetin has been licensed by the safety of drugs committee; what has been the length of time it has been under consideration by the Committee; what information he has on the length of time it has taken to approve the medicine in other European Economic Community countries; and what information he has on the reasons for the time required for approval in the United Kingdom.
§ Mrs. Virginia Bottomley[holding answer 5 February 1990]No product licence for erythropoetin (EPO) has been granted in the United Kingdom. In general terms the time needed to obtain marketing authorisation in the United Kingdom for a medicinal product containing a new active substance (NAS) produced by biotechnology, such as EPO, will depend on a number of factors. Such an application must be made through the European Community's concertation procedure, introduced under directive 87/22/EEC. This involves the Community's committee for proprietary medicinal products (CPMP) in giving a non-binding opinion which must be taken into account by national regulatory authorities when making decisions for marketing in their own territories—for which they alone are responsible. In the light of advice from the CPMP and any national advisory committee, for example the Committee on Safety of Medicines in the UK, each authority must decide for itself whether any additional information is needed from the applicant company before reaching its own independent decision. The CPMP opinion is often written in rather general terms and hence important additional data may have to be supplied by the company before individual national licensing authorities can be reassured as to the safety, quality and efficacy of the product. Only when the reassurance has been provided can the licence be granted. On occasions further time may also be required before the application can be cleared if an applicant company decides to exercise its appeal rights. The Department does not hold information relating to the time taken by other regulatory authorities within the European Community to grant marketing authorisations.