UK Regulatory Agency Outlines Plan Post-Brexit

The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) released a report to highlight a proposed model for the future regulation of medicines in the UK post the UK leaving the European Union. So what does the MHRA have in mind?.

Part of the agency’s model is to develop an international and enhanced national strategy for collaboration and engagement with key partners and stakeholders. A top priority is to continue the agency’s role in securing global supply chains through global strategic alliances, including harmonization of standards, information sharing, inspection, and enforcement. DCAT Value Chain Insights examines the MHRA’s post-Brexit strategy.

Regulation of medicines post Brexit
In its report, the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) highlighted that one of its top priorities is to navigate successfully the uncertainty posed by Brexit. To that end, among its top 10 priorities for 2017/2018, the agency is emphasizing the development of a proposed model for future regulation of medicines and medical devices in the UK, the development of an international and enhanced national strategy for collaboration and engagement with key partners and stakeholders, and further measures to ensure the security of global supply chains.

With respect to forming a model for the agency post-Brexit, the MHRA has set forth certain key objectives, including supporting the UK in Brexit negotiations with the European Union (EU). Key approaches include a European engagement strategy that involves working out future relationship and engagement with the agency’s European counterparts in a post-Brexit context, including the potential for ongoing cooperation in EU regulatory procedures. It further involves optimizing the UK’s regulation strategy, including financially, and developing a plan that analyzes commercial development opportunities in the approach to Brexit and beyond. The other components in its post-Brexit strategy are to include a communications and reputation strategy and an employment strategy to ensure the agency has the right skills in place now and in the future.

The MHRA is also emphasizing the need to build international cooperation in its regulatory activities. It says a key goal is to develop an innovative, attractive, post-Brexit regulatory offer. This will involve playing a leading role in global discussions about the future regulatory environment for pharmaceuticals and medical devices, actively engaging in global vigilance and inspection partnerships, and considering strategic alliances with other regulators worldwide.

Part of its priorities in building its international strategy is to provide effective chairmanship and secretariat of the International Coalition of Medicines Regulatory Authorities, a voluntary, executive-level, strategic coordinating, advocacy and leadership entity of regulatory authorities. The MHRA also said it wants to develop deeper relationships with key countries (e.g. China and India) and, in a Brexit context, with other leading global regulators as part of a coherent international strategy. Within Europe, it wants to continue to engage in Heads of Medicines Agencies (HMA) discussions, including leadership of the innovation workstream, input to other project areas, support to the EU Telematics/IT strategy, and delivery of updates on the innovation workstream at all HMA meetings in 2017/18. It also wants to establish an EU combined working group of medicines and medical device regulators on borderlines and combination products with willing parties to develop a consistent approach.

Within the UK, the agency said it want to further contribute to Medicines Manufacturing Industry Partnership (MMIP), a joint initiative between the UK and the UK pharmaceutical and biopharmaceutical industries, to contribute to create a long-term strategic partnership between industry and the government to drive an increase in UK manufacturing and exports. For the MMIP regulatory workstream, the agency has a goal of developing a paper that demonstrates how companies can use regulatory flexibilities in relation to manufacturing, licensing, and inspection.

With regard to securing the global supply chain, the agency outlined several key goals: continued progress in the implementation of the signed mutual reliance initiative with the US Food and Drug Administration for acceptance of UK and US inspection standards; continuing the role of chair of the Pharmaceutical Inspection Co-operation Scheme, a non-binding, informal co-operative arrangement between regulatory authorities for good manufacturing practices; and continued international cooperation with medicines regulatory authorities.

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