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Rtc med-directors event-2012-05-16


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  • 1. Safeguarding public healthRegulatory Excellence &The Red Tape ChallengeStephen Fawbert ©
  • 2. Better regulation - HeadlinesRed Tape Challenge (RTC) forms part of the Agency’sRegulatory 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. implementdirectives or changes to directives)Keen to continually review regulation as well as processes,which we believe are equally important – interface andinteraction key Slide 2 ©
  • 3. Further Burden Reduction - OverviewBurden Reduction New Regulation/initiativesWork in hand EUConsolidation of medicines legislationRed Tape Challenge Falsified medicines: implementationFees simplification April 2012 Pharmacovigilance: implementationBROMI Revision of Medical Devices directives (including labelling of devices): influencing EU proposalsDispensing errors Clinical trials: influencing EU proposalsLicensing Division proposals on PLPIs (removingsupplier list requirements and simplified mock-ups)Removal of requirements for full-colour mock-upsFurther Work to consider / scope / resource UK2nd round of work on Consolidation Review of unlicensed medicinesReview of sanctions and penaltiesReview of guidance? Slide 3 ©
  • 4. Red Tape Challenge Slide 4 ©
  • 5. Slide 5 ©
  • 6. 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. Slide 6 ©
  • 7. Red Tape Challenge LookingForward 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 Slide 7 ©
  • 8. By the end of 2012•Developed the regulatory programme for the Agency•Commissioned monitoring activities to ensure programme ismaking the right impact and to assess cost savings•Developed a package of proposals following the RTC andgathered intelligence on how we can improve•Concluded our consultations on consolidated medicineslegislation and pharmacovigilance implementation Slide 8 ©
  • 9. Priorities moving forwardWork programme enables the Agency to establish acomprehensive 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 Slide 9 ©