Regulatory Focus™ > News Articles > 2020 > 6 > EU Regulatory Roundup: Regulators to prioritize COVID-19 procedures if needed

Posted 04 June 2020 | By Nick Paul Taylor 

EU Regulatory Roundup: Regulators to prioritize COVID-19 procedures if needed

2720 COVID-19 procedures will be prioritized if members of the European Medicines Regulatory Network (EMRN) cannot execute all activities, according to a business continuity plan developed by the European Medicines Agency (EMA) and the European Commission (EC).
The extent of capacity constraints defines the plan three-phase plan. In the first phase, members of EMRN can fulfill routine regulatory tasks for medicines authorized centrally and nationally. The third phase kicks in when there are constraints across the European Union.
A detailed plan for phase three has yet to be established. Rather, the business continuity plan focuses on phase two, a stage defined by capacity constraints at EMA or one or more national competent authorities. The plan describes how capacity from across EMRN will offset disruptions.
“Under no circumstances can COVID-19 related procedures be delayed; they should always be given first priority,” the plan states. The plan defines COVID-19 related procedures as activities tied to drugs and vaccines against the infectious disease, general treatments used in the management of people with the disease, and shortages caused by the pandemic.
If the rapporteur appointed to a COVID-19 procedure is unable to perform the assessment, EMA will find a temporary replacement to prevent delays. EMA will choose rapporteurs based on their ability to take on the work without delay, as well as routine considerations such as their expertise in the area.
A different process applies to non-COVID-19 procedures. In those cases, EMA will only replace the rapporteur after first seeing if it is feasible to “use utmost flexibility within the overall timetable without extending the overall timeframe for the procedure.”
EMA NoticeContinuity Plan
EMA creates guidance on qualifying digital technologies to support drug approvals
EMA has created a question and answer document to help drug developers qualify digital tools that can support filings for approval. The document applies to technologies such as patient monitors and electronic consent forms.
With digital technologies playing a growing role in clinical trials, EMA wants to ensure that they are reliable, particularly when capturing data about the benefits and risks of a medicine. That thinking led EMA to create a question and answer document that details the information companies should submit in requests for qualification advice.
EMA expects qualification submissions to “provide insight into the reliability, accuracy, precision, clinical validity, generalizability and clinical applicability of the methodology to be qualified, at a level of detail that is sufficient for assessment, yet not so detailed as to invalidate the qualification when, for example, minor software updates are implemented.”
The text features specific advice on what aspects applicants need to cover in qualification requests for clinical outcome assessments and digital biomarkers. The advice on different technologies overlaps somewhat, specifically on reliability and sensitivity to change.
Companies can send qualification requests to EMA at any point in development, although the agency sees value in early engagement that can support the iterative qualification of a technology.
Starting early allows companies to explore the use of technologies in early clinical trials. Other best practices identified by EMA include the identifying a clear research question and providing guidance on how a technology will be used in clinical development.
EMA plans to add to its advice in the future, reflecting the expectation that the pace of change in the field of digital clinical trial technologies will necessitate revisions to its current position.
DKMA misses annual regulatory targets
The Danish Medicines Agency (DKMA) failed to achieve 40% of its performance targets in 2019. Once partial successes were factored in, DKMA calculated it achieved 75% of its objectives, a drop of 14% compared to the prior year.
Going into 2019, DKMA set 15 objectives for the year, for example, by committing to hold three or more professional forum events to communicate with stakeholders. The agency hit that goal and eight others. However, it only partly fulfilled four other objectives and failed the remaining two goals outright. DKMA said the performance, which was worse than in 2018, was not satisfactory.
The two objectives that DKMA missed completely are related to the analysis of second priority signals and the processing of National Competent Authority Reports (NCARs). The agency aimed to analyze 75% of second priority signals to support European safety monitoring activities; in the end, the agency analyzed 30%. DKMA cited Brexit in its explanation of its failure to hit the target.
DKMA came closer to hitting its goal of processing all NCARs received from foreign regulators. Over the full year, the agency handled 80% of NCARs, despite needing to hire and train people to do the work, limiting the processing of NCARs early in the year. The agency processed 100% of NCARs in the second half of 2019.
In general, DKMA said its ability to deliver on its targets was negatively affected by the need to put a lot of effort into ensuring the continued supply of medicines. It highlighted work it performed in the second half of the year with other agencies to establish ways to monitor and maintain medicine supplies as a key area of focus. The agency has retained the topic as a top priority for this year.
DKMA Statement
Finland states clinical trials are exempt from recent health data legislation
The Finnish Medicines Agency (Fimea) has clarified that clinical trials are exempt from legislation on the secondary use of health data.
Last year, the Finnish parliament approved new legislation covering the processing of personal data collected during the provision of health services. Fimea and the Finnish Health and Social Data Permit Authority subsequently received questions about whether the legislation applies to data captured by clinical trials.
This week, Fimea clarified that the legislation does not apply to clinical trials. However, registry studies are subject to the legislation as they use information for purposes other than the reasons it was originally captured.
Fimea NoticeData Legislation
AEMPS asks industry to update video conferencing to support remote inspections
The Spanish Agency of Medicines and Medical Devices (AEMPS) has asked marketing authorization holders to update their video conferencing systems and online document sharing platforms to enable it to perform remote inspections.
With COVID-19 still disrupting life in Spain, AEMPS has decided to start assessing compliance with good clinical and pharmacovigilance practices remotely, sparing its inspectors from the need to travel or interact in person. However, remote inspections will only be possible if companies have technologies that enable AEMPS to review their practices.
As such, AEMPS is recommending companies update the systems they use for video conferencing and document sharing. The inspection team will assess whether a company has the systems needed to facilitate remote inspections when they approach the contact person at the organization.
AEMPS Notice (Spanish)


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