§ Mr. LoveTo ask the Secretary of State for Health (1) how many licence applications there were for medicines in each year since 1990; [100816]
(2) what was the total number of licence applications for medicines intended solely for the treatment of children in each year since 1995; [100818]
(3) what action the Medicines Control Agency is taking to (a) monitor and (b) implement the EU guidance on the licensing of medicines used in the treatment of children; [100817]
(4) how many pharmaceutical companies in the United Kingdom comply with EU guidance on the licensing of medicines used in the treatment of children; [100815]
(5) what was the total number of licence applications for medicines used in the treatment of children and adults in each year since 1995. [100819]
§ Yvette CooperInformation on how many pharmaceutical companies are complying with European Union guidance on the licensing of medicines used in the treatment of children is not held centrally.
The Medicines Control Agency assesses all applications for Marketing Authorisation (licences) in accordance with current EU legislation and guidance. This includes the guidance on the licensing of medicines used in the treatment of children. This guidance is not legally binding on companies. Applicants are asked to provide details of paediatric development plans if these are relevant and have been omitted from the application. Where appropriate, the MCA will indicate to the applicant that they should consider developing formulations which are suitable for children.
The total number of marketing authorisation applications for medicines in each year since 1990, 187W excluding applications from homoeopathic products and applications to import licensed medicinal products from other member states of the EU were:
Year Number 1990 939 1991 762 1992 1,055 1993 1,316 1994 1,277 1995 1,345 1996 1,349 1997 1,847 1999 1,290 The total number of licence applications for medicines intended solely for the treatment of children in each year since 1995 were:
Year Number 1995 40 1996 28 1997 54 1998 28 The total number of marketing authorisation applications for medicines used in the treatment of children and adults in each year since 1995 were:
Year Number 1995 555 1996 513 1997 681 1998 504