Euro Roundup: EMA shares draft on data strategy for EMRN

The European Medicines Agency (EMA) has published a draft paper on a strategy intended to increase the value of data for the benefit of public and animal health.

In the draft, EMA says the evolution of digital technologies and the growing volume and complexity of data presents challenges and opportunities for the European medicines regulatory network (EMRN). The draft document is intended to establish a coordinated approach to data management and use across EMRN to equip the network to manage the challenges and opportunities.

EMA identified “the varying levels of organizational maturity, skills and technical readiness across the network” as a significant challenge. The differences, plus financial limitations, “affect the speed at which data management improvements can be implemented and adopted uniformly,” EMA said, and create obstacles to achieving consistent practices and using advanced technologies in all member organizations.

The regulator, which drafted the document with the Heads of Medicines Agencies, has designed the plan to recognize the “diverse capabilities of its members” while enhancing data integration, interoperability, quality and access. EMA said the network “can improve processes, accelerate scientific assessments and strengthen its ability to protect public health across the EU” by adopting the strategy.

EMA has built the strategy around six principles. Five of the principles state data are an asset, are accessible, are shared, are managed and are safe and secure. The other principle covers a common vocabulary and definitions. The section on principles also addresses the ethical use of data. For each of the principles, EMA explains the rationale and the implications of its position.

“Data held within the EMRN should be understood and valued as much as other assets such as people, financial resources, and technology. It is important to note that the full value of data lies not just in its original purpose, but also in its potential to be reused for other purposes.” EMA said. “Data are expected to be FAIR (findable, accessible, interoperable and reusable) and machine-readable.”

The final section of the document covers the strategic objectives. EMA has 12 objectives split across six categories. In the data quality management category, the objectives are for the data quality framework to be commonly used across EMRN and for the quality of network data assets to improve. Other goals include generating additional business value by using and interconnecting EMRN data assets.

The draft is dated 6 September but was added to the EMA website on 15 November.

Draft Strategy

EMA updates good practice Q&A, adding question about supply chain traceability

EMA has revised its guidance on good manufacturing and distribution practices (GMPs/GDPs). The agency has added a new question and answer to a section about an annex on certification by a qualified person and batch release.

The new question asks how the traceability of the supply chain of the active substance and medicinal product should be documented to support the qualified person batch certification and release. EMA’s response explains how companies can meet the criteria for the process of certification set out in Annex 16 of the EU GMP rules.

“The complete manufacturing and distribution supply chain of the medicinal product and its related active substance up to the stage of certification, should be documented and available for the qualified person,” EMA said. “Supply chain records should provide adequate traceability and be available in a timely manner, to facilitate amongst others, quality defect investigations and product recalls.”

EMA expects companies to keep records that make it possible to identify all entities, including suppliers and outsourcing partners, that were “involved in the manufacture of a specific batch of the drug product, in line with the registered supply chain.” The requirement applies to active substances and medicinal products.

The agency added that the associated risks should be formally assessed when supply chain traceability is established. EMA expects companies to adopt appropriate risk-mitigation measures to mitigate any risks identified in the assessment. After that, companies should periodically review the risks.

EMA Q&A

MHRA names University of Oxford professor Anthony Harnden as its next chair

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has appointed Anthony Harnden as its next chair.

Harnden is a professor of primary care at the University of Oxford who worked in the UK healthcare service for 40 years. For 33 years, the incoming MHRA chair worked directly with patients as a general practitioner. Harnden is currently a registrant council member of the General Medical Council and chair of the Remuneration Committee but is set to leave those positions next month.

“Anthony brings with him a wealth of experience from across the healthcare sector and academia that will be invaluable when advising on the strategic direction of the agency to protect and promote public health,” MHRA chief executive June Raine said.

Harnden has filled a position that has been vacant since Stephen Lightfoot stepped down in 2023. Amanda Calvert, Michael Whitehouse and Graham Cooke have co-chaired the MHRA board on an interim basis for more than one year.

Industry group ABPI welcomed the appointment, predicting that Harnden’s “significant experience and expertise within the health ecosystem, especially his time at the [Joint Committee on Vaccination and Immunisation] during the COVID-19 pandemic,” will provide a strong foundation for his leadership.

Press Release, ABPI Notice

NICE fails to reach price agreement on Enhertu

The National Institute for Health and Care Excellence (NICE) has failed to reach an agreement with AstraZeneca and Daiichi Sankyo on the price of the breast cancer drug Enhertu.

NICE published final guidance recommending against the use of the antibody-drug conjugate Enhertu in HER2‑low metastatic or unresectable breast cancer in July. At the time, the institute said it was disappointed AstraZeneca and Daiichi had been “unwilling to offer [a] fair price.” The UK health secretary intervened to try to clear the deadlock.

Yet, this week NICE said “the companies did not put forward a cost-effective price that would have enabled us to recommend Enhertu as value for money for the taxpayer.” The failure to reach a deal ends a sequence of 21 positive recommendations for breast cancer drugs from NICE.

Claire Rowney, chief executive of Breast Cancer Now, said “we’re beyond devastated” that the two sides failed to reach an agreement. Rowney said Enhertu is available in Scotland and 18 other European countries, adding that “no-one should ever be in a position of considering moving to another country as the only way to access a life-extending treatment.”

NICE Statement

EMA supports Leqembi use in Alzheimer’s subpopulation, reversing initial rejection

EMA has recommended Eisai and Biogen’s Leqembi for use in a subpopulation of Alzheimer’s disease patients after re-examining its original decision.

The recommendation covers the use of the anti-amyloid-beta antibody in people with mild cognitive impairment or mild dementia due to Alzheimer’s who have only one or no copy of ApoE4. EMA said people with one or no copy of the gene are less likely to experience amyloid-related imaging abnormalities (ARIA), a side effect that informed its initial rejection of the application.

After restricting use to the subpopulation, EMA concluded the benefits of Leqembi outweigh the risks, provided risk minimization measures are in place. The measures are intended to reduce the risk of severe and symptomatic ARIA and monitor its consequences in the long term.

EMA Notice

Euro Roundup: EMA shares draft on data strategy for EMRN

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