Euro Roundup: Commission proposes ways to improve the security of medicine supply

RoundupsRoundups | 20 October 2022 |  By 

Perceived regulatory complexity is a key driver of supply chain vulnerabilities for medicinal products, according to a European Commission staff working document created to present the findings of talks between the Commission, industry and other stakeholders.
Last year, the Commission started a dialogue with “actors in the pharmaceuticals manufacturing value chain,” public authorities, patient and nongovernmental organizations, and the research community to understand how supply chains work and to identify the causes and drivers of vulnerabilities. The talks were triggered by the initiation of work on the Pharmaceutical Strategy for Europe the previous year.
Industry representatives said the lack of international regulatory convergence, for example on environmental legislation and post-approval changes, and the complexity of legal frameworks across jurisdictions globally “negatively affects the ability to respond in a flexible, effective and timely manner to supply chain challenges.” Manufacturers used the forum to call for change.
“The industry representatives called for a more risk-based approach to post-approval changes to authorisations, noting that the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use guidelines on this subject have already been adopted,” the Commission staff wrote in the working document. This lack of convergence “presents greater challenges, in particular during crises, when swift adaptations to supply chains are needed to ensure that increased demand can be met.”
Representatives of off-patent manufacturers identified the cost of regulatory compliance as a factor that drives the industry to cut costs and consolidate businesses, both of which can make supply chains more vulnerable. Commission officials also heard that regulatory frameworks should facilitate the introduction of digital manufacturing technologies and support “novel manufacturing approaches and efficient post-approval change management throughout the medicinal product lifecycle.”
In the second part of the document, which covers the mapping of EU-level areas of focus, the Commission discussed optimizing the regulatory environment to address feedback that “practical compliance with regulatory procedures is very complex and burdensome” and that it is behind the times in terms of the use of digital tools.
Through the pharmaceutical strategy, the Commission aims to improve regulatory efficiency by streamlining procedures, allowing for timely adaptation of technical and technological development and improving medicines lifecycle management. The Commission acknowledged that improving the regulation of digital infrastructure or tools “based on harmonized and interoperable approaches” could contribute to the security of supply. The Commission also proposed greater regulatory convergence and the promotion of EU good manufacturing practices globally as ways to potentially improve supply.
Working Document
EMA updates guidance for applicants seeking scientific advice and protocol assistance
The European Medicines Agency (EMA) has revised its advice on the role of the scientific advice working party (SAWP), the structure of the briefing package and other topics in an update to its guidance for applicants seeking scientific advice and protocol assistance.
EMA has made significant changes in version 14 of the document, deleting some questions, adding new sections and overhauling some of its existing responses. The wholly new questions include a discussion of the role of the SAWP, which EMA presents as a permanent working party charged with drafting scientific advice and protocol assistance for orphan medicinal products.
In another new section, EMA outlines the structure and content of the briefing package for scientific advice or protocol assistance. The agency also deleted questions on submitting the final electronic package and the timelines for notification of a scientific advice or protocol assistance procedure.
Other changes include the rewriting of the response to a question on whether advice and assistance can be requested on pediatric development. The response now states that applications can request scientific advice on matters such as design elements of a specific study included in a pediatric investigation plan and on combined adult and pediatric developments in certain circumstances. However, EMA also lists a set of questions that should not be the subject of scientific advice and protocol assistance.
EMA has also overhauled its advice on how to apply for scientific advice and protocol assistance, including by expanding the discussion to include how the application will be validated, and offered extra advice on how to prepare for a discussion meeting.
EMA Guidance
MHRA publishes roadmap for software and AI as a medical device change program
The UK Medicines and Healthcare products Regulatory Agency (MHRA) has published objectives and deliverables for the work packages in its software and AI as a medical device change program.
Last year, MHRA created 11 work packages to support its attempt to provide a regulatory framework that both protects patients and makes the UK “the home of responsible innovation for medical device software.” The plan was to ensure the requirements provide a high degree of assurance that devices are acceptably safe and are clear and supported by guidance and streamlined processes.
Now, MHRA has updated the document by providing a roadmap that expands its plans for the work programs. For example, the first work package, titled qualification, now features a problem statement addressing the lack of clarity as to what qualifies as software as a medical device (SaMD), and a deliverables section featuring three regulatory guidance documents.
Through the first guidance document, MHRA will seek to clarify various distinctions, such as the difference between SaMD and wellbeing and lifestyle software products. The other guidance documents will help manufacturers define the intended purpose of their medical device and clarify the concept of “manufacturer” for SaMD.
Across the other 10 work packages, MHRA has detailed a range of secondary legislation and guidance documents that it thinks are needed to inform device classification, pre- and post-market requirements and other aspects of the regulation of SaMD.
MHRA Roadmap
MHRA seeks feedback on how to improve medical device safety reporting systems
MHRA has asked healthcare professionals for feedback on its safety communications and reporting systems. The consultation could shape the future of the Yellow Card scheme used to report adverse events.
In the consultation, MHRA asks if healthcare professionals are aware of and have used the Yellow Card system, which enables the reporting of suspected side effects or adverse drug reactions and medical device incidents. The agency wants to know what routes healthcare professionals would like to use to report concerns about medicines and devices and how it should engage with them.
MHRA is seeking feedback from general practitioners, nurses, pharmacists, dentists, midwives, specialty care doctors, technicians and other registered medical professionals. As well as asking questions about the adverse event reporting system, the agency is seeking feedback on how healthcare professionals learn about the safety communications it releases.
Press Release, MHRA Consultation
Other news:
The European Directorate for the Quality of Medicines & HealthCare (EDQM) has released a new draft monograph on cannabis flowers for consultation. The monograph is informed by reports from national authorities. EDQM is accepting feedback until the end of the year. EDQM Notice


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