Question to the Department of Health and Social Care:

To ask the Secretary of State for Health, how many (a) new cancer medicines and (b) new indications of existing cancer medicines are expected to be licensed between July 2015 and 31 March 2016.

There are currently 11 applications for new cancer medicines and 15 applications for new indications for existing cancer medicines under review by the Medicines and Healthcare products Regulatory Agency (MHRA) as part of European Centralised Procedures submitted to the European Medicines Agency (EMA). There is one further application for a new indication for an existing cancer medicine under review by MHRA in an application submitted in the United Kingdom as part of a Mutual Recognition Procedure.

Under European Centralised Procedures, it takes up to 210 days for an opinion on licensing for new applications and 120 days for an opinion on variation applications for new indications to be given by the scientific committee of the EMA, the Committee for Human Medicinal Products (CHMP), excluding time taken by the Company to provide further information or data to support any questions which may arise during the assessment process. If the assessment concludes that the quality, safety and efficacy are satisfactory and a positive opinion is given by the CHMP, the European Commission will then consider the opinion and decide upon granting or varying a marketing authorisation, valid across the European Community. For a national variation procedure, the same timeline of 120 days, excluding time taken by the Company to provide further information, applies.

At this time, the MHRA, the UK Government body responsible for medicines regulation in the UK, is unable to provide more precise detail on the timeline for completion of the review of the applications currently with the EMA and MHRA, and it is not possible to predict with certainty what will be licensed between July 2015 and 31 March 2016, nor can any information be provided on applications not yet submitted but which may be approved before 31 March 2016.