Brexit, medicine availability top EMA stakeholder report

Regulatory NewsRegulatory News | 22 January 2021 |  By 

Brexit readiness, regulatory science strategic planning, and medicine availability topped the list of big-picture areas of engagement between the European Medicines Agency (EMA) and industry stakeholders in a newly released biennial report.
The EMA report, released Friday and covering the 2018-19 biennium, was presented to EMA’s Management Board in December 2020. It provides a high-level look at interaction between the European regulator and the pharmaceutical industry.
The run-up to Brexit was top of mind for EMA and stakeholders alike during the two years covered by the report, a period that saw the relocation of EMA headquarters from London to Amsterdam. “During this period, Industry stakeholder’s engagement has primarily focused on ‘Brexit’ preparedness activities. EMA, the European Commission and Head of Medicines Agencies (HMA) continued to engage closely with industry stakeholders to prepare for the UK leaving the EU and becoming a third country,” according to the report.
Looking forward, EMA also worked with stakeholders to develop a regulatory science strategy through the year 2025. A series of public and stakeholder consultation opportunities resulted in “rich input and discussions,” with the final strategy being honed with member states’ input; areas of focus address rapid technological change and innovation in the pharmaceutical industry.
Ensuring the availability of authorized medicines was a key priority for EMA during this period. Medicine unavailability is “an area of great concern” with big end-user impacts, wrote EMA, and a host of factors can contribute o unavailability. A 2018 workshop was followed by a 2019 guidance on detecting and reporting medicine shortages with the aim of achieving early notification of potential supply chain or production issue, so that regulators have “sufficient time to make contingency arrangements where necessary.”
In one highlight, EMA noted that, high levels of engagement were required in formulating an approach to the detection and prevention of potentially carcinogenic nitrosamine impurities in medicinal products. Here, stakeholder consultation and a November 2019 stakeholder meeting led to a “lessons learned” exercise, and then a public report with specific recommendations for manufacturers and regulators.
Another area with a high level of stakeholder interaction addresses the challenges post by big data. A big data task force invited industry to a May 2019 multi-stakeholder task force, following an interim report published earlier that year that laid out “challenges and the current state of expertise in the regulatory network.” The final report includes “practical recommendations on how the network could make best use of big data by evolving its approach to data use and evidence generation in support of innovation and public health,” according to the stakeholder interaction report.
Support for small and medium enterprises (SMEs), “recognized as a driver of innovation in the EU,” was an additional arena of engagement highlighted by EMA in the report, which details the dedicated resources and support offered to the enterprises. These include fee incentives, as well as tailored training and a dedicated newsletter.
Further support for human medicine SMEs included two stakeholder platform meetings focused on research and development support and another two dedicated to pharmacovigilance. Brexit-related activities disrupted plans for 2019 activities.
The report lays out operation of the European Medicines Regulatory Network, including telemarics efforts within the EU; Brexit and the relocation of EMA headquarters to the Netherlands also affected 2019’s planned activities in this area.
Stakeholders and EMA continued to work closely on EudraVigilance, according to the report. Specific areas of progress included drafting options for mandatory adoption of the new ISO ICSR/ICH E2B(R3) standard, with the upshot that the standard and associated terminology will be mandatory beginning 30 June 2022 as they pertain to EudraVigilance.
Other EudraVigilance-related areas of interaction included drafting an operational plan, resolving technical issues, integrating Eudravigilance with EMA’s Identity and Access Management system, and conducting webinars and in-person training. EMA also conducted ongoing testing with sponsors and marketing authorization holders throughout the period.
Implementation of common data elements, formats and terminologies for identification of medicinal products according to ISO standards was another area where EMA engaged with stakeholders. The development of the integrated regulatory and scientific information management system dubbed IRIS, first launched in 2018, has required ongoing collaboration and engagement. The platform was first used for orphan designation procedures in 2018, with uses expanding over time. EMA used feedback from a 2019 user satisfaction survey to shape further IRIS design changes.
Electronic product information is a future goal for EU medicines, said the report, and improvements in labeling to enhance readability and achieve other patient-centric goals has helped further progress to that end.
EMA also conducted consultation in the process of implementing clinical trials legislation; during the biennium, a system for clinical trial safety reporting was finalized, with representatives conducting user testing and providing feedback.
Further collaboration was required for the upcoming EU in vitro  and medical device regulations “which introduce new responsibilities for EMA.” Workshops and other industry engagement about considerations for combination products, an EMA webpage on medical device, guidance documents, and a question and answer document are some of the results of these coordinated activities.


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