Research and analysis

MHRA: business impact target

The Medicines and Healthcare products Regulatory Agency (MHRA) assesses its regulatory impact on businesses.

Documents

MHRA QRP Summary - Year 2

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MHRA NQRP Summary - Year 2

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RPC opinion - Co-ordination of safety and risk management materials for generic medicines

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RPC opinion - E-correspondence via CESP

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RPC opinion - Improved process on reclassification of medicines; dedicated contact for backlog submissions; removing need to communicate with a named individual over clinical trials

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Details

The business impact target (BIT) is a cross-government target for the reduction of regulation on business.

Under the BIT, MHRA assesses the financial impacts on business of qualifying regulatory provisions (QRPs). QRPs are changes to regulatory practices that are described in a written ministerial statement. We assess the impacts of these changes through BIT assessments.

We submit BIT assessments for QRPs to the Regulatory Policy Committee (RPC) for validation.

Non-qualifying regulatory provisions (NQRPs) are excluded from the BIT as set out in a written ministerial statement. We submit NQRP summaries to the RPC for certification.

Summaries of the MHRA’s QRPs and NQRPs are available on this page.

Published 8 June 2017
Last updated 17 August 2017 + show all updates
  1. Updated MHRA NQRP Year 2 summary
  2. Added three validated RPC opinions.
  3. First published.