The Pharmaceutical Journal
Vol 274 No 7342 p351
26 March 2005

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Consultation letter PDF (70K) and annexes PDF (640K)
Online response form

Consultation to strengthen regulation launched by MHRA

Views on proposals to implement new EU medicines legislation in the UK are being sought by the Medicines and Healthcare products Regulatory Agency. The legislation is designed to strengthen medicines regulation.

The MHRA has already implemented early some aspects of the new legislation, including mandatory user-testing of patient information leaflets and provisions to encourage POM-to-P switches (PJ, 7 August 2004, p175).

The latest consultation proposes:

· Risk management plans for medicines at the time of licensing
· Publication of assessment reports on new medicines
· An obligation on industry to inform the regulator of issues that will impact on the safety of marketed medicines
· Provision of a balanced package of measures for the research-based and generics pharmaceutical industries by recognising the need to reward innovation and providing rapid entry to the market for generic medicines

The MHRA says it aims to increase transparency and safeguard public health in a way that enhances the regulatory framework without hindering advancements in the pharmaceutical industry.

The consultation closes on 16 June and comments on the proposals can be made via the website or sent to Andrew Kaye, Review of EU Medicines Legislation, MHRA, Room 16-157, Market Towers, 1 Nine Elms Lane, London SW8 5NQ.