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Safeguarding public health

Regulatory Excellence & The Red Tape Challenge

Stephen Fawbert

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Better regulation - Headlines

Red Tape Challenge (RTC) forms part of the Agency’s

Regulatory Excellence (RegEx) programme

RegEx looking at burden reduction activities (e.g. BROMI – well-established element of the burden reduction programme) plus how we introduce new regulation (e.g. implement directives or changes to directives)

Keen to continually review regulation as well as processes, which we believe are equally important – interface and interaction key

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Further Burden Reduction - Overview

Burden Reduction New Regulation/initiatives

Work in handConsolidation of medicines legislation

EU

Red Tape Challenge Falsified medicines: implementationFees simplification April 2012 Pharmacovigilance: implementationBROMI Revision of Medical Devices directives (including

labelling of devices): influencing EU proposals

Dispensing errors Clinical trials: influencing EU proposals

Licensing Division proposals on PLPIs (removing supplier list requirements and simplified mock-ups)

Removal of requirements for full-colour mock-ups

Further Work to consider / scope / resource2nd round of work on Consolidation

UKReview of unlicensed medicines

Review of sanctions and penalties

Review of guidance?

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Red Tape Challenge

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Red Tape Challenge

MHRA staff were briefed on RTC and undertook internal challenge

We were keen to encourage debate on both regulation and processes

Went live on 9 March for five weeks

Included a pharmacy theme with 2 DHI MPI regulations

We are currently working through & assessing the hundreds of comments & proposals received.

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Red Tape Challenge Looking Forward

Developing a package of proposals from the RTC process by June 2012

Cross government discussions on the package will take place through July and August 2012

Final set of proposals will be developed and published by September 2012

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By the end of 2012•Developed the regulatory programme for the Agency

•Commissioned monitoring activities to ensure programme is making the right impact and to assess cost savings

•Developed a package of proposals following the RTC and gathered intelligence on how we can improve

•Concluded our consultations on consolidated medicines legislation and pharmacovigilance implementation

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Priorities moving forward

Work programme enables the Agency to establish a comprehensive programme of activity to:

• Assess the effectiveness of current regulation

• Influence the shape of future regulation

• Use evidence to challenge where we do not believe regulatory proposals are in UK interest

• Ensure we stay business-friendly and work together to create a proportionate, effective, regulatory landscape