Euro Roundup: MHRA aims to eliminate current backlogs by end of Q4 in 2023-24 business plan

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has committed to clearing its current service backlogs by the end of the fourth quarter as part of its business plan for the 2023 to 2024 financial year.

MHRA has struggled to meet its targets as it adapts to Brexit and budget changes. The wait for initial review letters for Phase 1-4 clinical trials in patients more than doubled between June 2022 and March 2023, contributing to the decision to make delivery of “predictable and reliable operational performance” one of the goals of the first year of its 2023-2026 corporate plan (Related: Euro Roundup, Regulatory Focus 19 April 2023).

The agency published its 2023-2036 plan in July and provided more details about its first-year objectives last week.

“There will be a number of important developments, including optimization of our service delivery times in priority areas, improved patient access to innovative products by formalizing new recognition pathways for the UK and the introduction of new guidance and legislation on critical areas such as clinical trials, medtech and UK point of care manufacture,” MHRA wrote.

MHRA sees the year as a chance to “build on [its] opportunities as an independent regulator in particular to strengthen patient safety,” but it also needs to get back to the consistency of performance that it has achieved in the past. The agency has set itself four objectives related to the delivery of predictable and reliable operational performance; it aims to complete all by the end of its fourth quarter:

Identify service improvements and establish robust plans for implementation across all priority areas;
Eliminate backlogs;
Deliver phase one of an innovation-enabling and risk-proportionate medicines compliance strategy, including a pilot of an outcome-based model; and
Fully embed the new SafetyConnect vigilance system and realize patient and operational benefits.

“We are working hard to improve our performance timelines for licensing of medicines. Recruitment to vacant roles, changes in practices and service redevelopment, along with industry awareness have been critical themes in ensuring our performance improves,” MHRA wrote. “To improve our performance timelines for assessment of established products, we have undertaken the Established Medicines Task and Finish Group to work collaboratively with industry.”

MHRA aims to hit its established medicine target by 1 January but has set “phased targets” that “take account of current challenges and provide a realistic estimation of expected performance.” The agency is increasing its target for the percentage of medicine it assesses within 210 days from 50% under the old plan to 80% for 2023/24 and 90% for 2024/25.

The plan also covers MHRA’s financial situation. The agency aims to become financially self-sufficient for all its day-to-day operational responsibilities in the 2023-2024 period. However, because it is unable to use income for capital investment, it will rely on the Department of Health and Social Care for money to implement new government priorities and “build the digital technology and data analytics capabilities.”

MHRA Plan

EMA proposes changes to guideline on the clinical investigation of depression treatments

The European Medicines Agency (EMA) has published draft guidelines on the clinical investigation of medicinal treatments for depression. EMA has rewritten and restructured the document it finalized in 2013 to reflect changes in the treatment and drug development landscape.

Officials signaled their intent to update the current guidance in 2016 when they released a draft concept paper about the need to provide advice on trials in partial and non-responders and the targeting of new functional domains. EMA missed its target for releasing draft guidance, September 2017, by six years but the proposals nonetheless reflect some of the objectives of the concept paper.

The draft covers the definition and identification of partial and non-responders and the design of trials in patients with treatment-resistant depression. EMA also addresses the clinical development requirements for targeting sub-domains of depression such as sleep disturbance and cognitive dysfunction.

In addition, EMA has added sections on rapid-acting antidepressants and psychedelics that describe how the nature of the emerging therapeutic classes shapes the design of clinical trials. In the psychedelic section, EMA discusses how to mitigate the risk of overestimation bias and the nocebo effect affecting outcomes.

EMA has yet to set dates for the start and end of the consultation.

Draft Guideline

Pharma meets Ukrainian government to discuss creation of independent regulatory agency

Pharma trade groups have met with the Ukrainian government to discuss the creation of an independent regulatory agency and other actions that could support the country’s accession to the EU.

EFPIA and Medicines for Europe, trade groups that represent branded and off-patent drugmakers, put out separate statements about meetings with a Ukrainian government delegation. The statements cover similar points about the actions that Ukraine and other stakeholders can take to improve its regulatory environment and prepare to join the EU.

According to EFPIA, the meeting covered the need for transparent and efficient regulatory processes to ensure products reach patients faster, the creation of independent regulatory and health technology assessment bodies, restarting clinical trials in Ukraine and an agreement on manufacturing inspections.

“This would include streamlining and digitizing approval processes to make them more transparent and efficient and would ultimately ensure that products can enter the Ukrainian market faster and allow timely access to the patients that need them,” EFPIA wrote.

EFPIA Statement, Medicines for Europe Statement

Trade group calls for ‘clearer regulatory narrative’ about international recognition at MHRA

UK pharma trade group ABPI has called for MHRA to provide a “clearer regulatory narrative” about what the flexibilities of a planned international recognition policy will mean for product pipelines. MHRA plans to switch to the international recognition procedure on 1 January and recently provided guidance on the new approval route.

Predicting that most innovative drugs will follow the slower, 110-day pathway, ABPI called the plan “not particularly competitive” and challenged MHRA’s claim that it will support faster product approvals.

“It is not clear what this route is faster than as the MHRA must wait first for the product to be approved elsewhere. It is also not yet clear how the agency perceives the relative importance of each of the flexibilities listed above in supporting the life sciences ecosystem and early patient access,” ABPI wrote.

The trade group wants a clearer narrative regarding route to market and how it relates to other mechanisms, such as the Early Access to Medicines Scheme.

ABPI Statement

Other news:

The Swiss Agency for Therapeutic Products (Swissmedic) plans to launch a freely accessible database of good manufacturing and distribution practice certificates in the first quarter of 2024. The SwissGMDP database will be like EudraGMDP and is intended to cut industry costs. Swissmedic will include certificates for all companies with valid Swiss establishment licenses. Swissmedic Notice

Euro Roundup: MHRA aims to eliminate current backlogs by end of Q4 in 2023-24 business plan

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