Euro Roundup: MHRA misses performance targets amid resource constraints, Brexit backlogs

RoundupsRoundups | 21 July 2022 |  By 

The UK Medicines and Healthcare products Regulatory Agency (MHRA) missed multiple performance targets for its 2021-2022 financial year due to resource constraints, Brexit backlogs, and additional reasons.
MHRA started the financial year aiming to produce 97% of validation reports for new marketing authorization applications within 14 days of case creation; instead, the agency achieved the 14-day target 83.4% of the time.
“Embedding centrally authorized products (CAP) grandfathering transition activities resulted in backlogs in Q1 and a missed target,” MHRA wrote in its report. CAP grandfathering refers to the conversion of all existing EU marketing authorizations to British authorizations because of  Brexit. MHRA cited the same pressures as a reason why it missed the target in its 2020-2021 financial year.
With the backlog cleared, MHRA said “performance was recovered” in the second quarter and “returned to target” in the second half of the year
MHRA is looking to its new organizational structure to improve performance against other targets, such as the 80-day goal of assessing applications to market new active substances 97% of the time.
After achieving a 100% success rate in 2020 to 2021, MHRA’s performance slumped to 92% last year because of three assessments that exceeded the time target. One assessment “was very complex due to the rarity of the disease,” MHRA said, and was affected by the prioritization of reviews of COVID-19 antivirals. The other two assessment “went marginally beyond the 80-day timeline because of scheduling issues and resource constraints,” MHRA said. The agency expects the new organizational structure to address the resourcing issues and get it back on target by the end of the second quarter of the current financial year.
MHRA listed its new organizational structure as the solution to several other underperforming areas, including the provision of initial feedback from Independent Scientific Advisory Committee (ISAC) review of Clinical Practice Research Datalink research applications. The agency aims to provide initial feedback from ISAC review within 30 days 90% of the time. MHRA just missed that target last year because of resourcing issues but expects to get back on track in the second quarter.
The agency set the same timeline for getting the assessment of applications for new marketing authorizations in Europe, decentralized and mutual recognition procedures back on target. Again, MHRA cited resource constraints to explain the failure to hit the target and listed its new structure as the solution.
MHRA Report
EMA releases plan to create digital hub for regulatory network
The European Medicines Agency (EMA) has published a technology capability investment plan, outlining how it will invest through 2025 to fulfill its ambition to become the digital hub for the European medicines regulatory network.
The plan describes the key operational and technology investments EMA will make to drive the modernization of its capabilities and become more customer-centric, agile and innovative. The plan builds on the EMA Cloud Strategy and sets the agency a series of targets grouped into two categories: operational excellence and transform and innovate.
The next milestone, scheduled for early next year, is “100% of portfolio in Agile,” a term for software development practices and values. EMA also aims to have an “Agile delivery framework in place” and to implement “target architecture” by the end of next year. The creation of an agile delivery foundation is intended to support initiatives related to security, data standardization and more.
EMA has four other milestones for 2024 and 2025. In 2024, the agency aims to establish 100% monitoring for business-critical applications and have all data exchange based on international standards. The following year, EMA will work to ensure most applications are cloud-native and to refresh the investment plan for the next phase.
EMA Plan
EMA creates guidance for patients and healthcare professionals to prevent shortages
EMA and the Heads of Medicines Agencies (HMA) have published good practice guidance for patient and healthcare professional organizations on the prevention of medicine shortages.
The document discusses “proactive mechanisms to prevent shortages.” Because physicians and patients are at the end of the supply chain, their actions are “usually limited to demand management strategies.” However, EMA and HMA want to go beyond the standard strategies to look at ways to improve planning, preparedness and rationing to prevent shortages and manage the impact of future disruptions.
Some of the policy recommendations affect manufacturers. EMA is encouraging the identification of good procurement practices that address predictability and profitability for manufacturers. The practices could include tender criteria that go beyond price to cover factors such as quality track record.
“Procurement practices focusing solely on the price have resulted in manufacturers pulling out of national markets, leading to market consolidation, and consequently increasing the risk of medicines shortages. Allowing more than one winner for tenders of pharmaceutical products would lower the risk of single supplier dependence,” the guidance states.
EMA suggested harmonizing tender cycles within and across countries, switching to national procurement of medicines in short supply and requiring pharma companies to “submit shortage prevention plans to competent authorities when they market a medicine.” The plans are seen to identify risks and promote mitigation measures. EMA also set out a desire to diversify supply sources and reduce Europe’s reliance on external manufacturing.
EMA Notice
AEMPS-affiliated notified body becomes first Spanish group designated under MDR
A notified body associated with the Agency of Medicines and Medical Products (AEMPS) has become the first Spanish group designated to assess products under the EU Medical Device Regulation (MDR).
The National Center for the Certification of Medical Devices (CNCps) is a public group attached to the Spanish medicines regulator AEMPS, setting it apart from the private, commercial enterprises that are active in other countries. AEMPS said CNCps has the experience and knowledge of its certification area, which was the only Spanish notified body designated under the old directives.
CNCps began the MDR designation process in 2019. The designation brings the number of MDR notified bodies up to 31. CNCps is the only Spanish notified body on the list. There are no bodies from neighboring Portugal on the list.
The notified body is now working on In Vitro Diagnostic Regulation (IVDR) designation. CNCps began the process one year ago. Designation of CNCps under IVDR would lessen the geographic concentration of the IVDR notified bodies. When the European Commission proposed longer IVDR transition periods, it said the concentration is “particularly problematic for SMEs established in other member states, which have a tendency to apply to notified bodies in their own or neighboring member states.”
Nando Entry, AEMPS Notice (Spanish)
Other news:
MHRA is making a low-dose hormone replacement therapy product available from pharmacies without a prescription. The classification change affects the estradiol-based Gina 10 microgram vaginal tablets, which are used to treat vaginal symptoms such as dryness, soreness, itching, burning and uncomfortable sex caused by estrogen deficiency in postmenopausal women. MHRA Notice


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