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Posted 10 February 2022 | By Nick Paul Taylor 

Euro Roundup: EMA warns sack of COVID temp staff will hurt

2771 The European Medicines Agency (EMA) has warned the termination of 40 temporary pandemic staff will “significantly impact” its ability to perform post-authorization activities and other ongoing responsibilities related to COVID-19.
 
Recognizing the strain that the pandemic was placing on EMA, European Union officials authorized 40 temporary staff in 2021 and 2022. COVID-19- related work currently occupies 70-80 full-time equivalents at the agency.
 
In a planning document for the years 2022-2025, EMA discussed what will happen if, as is expected, the agency loses the additional staff in 2023. By then, the acute stage of the crisis may be over, but EMA expects to still be feeling its aftereffects.
 
“In consideration of the fact that the workload generated by the response to the COVID-19 pandemic (e.g. in post-authorization activities) will extend beyond 2022, the termination of the 40 additional [temporary agents] posts will significantly impact the Agency’s capacity to deliver on these activities,” EMA wrote in the planning document.
 
The additional pandemic staff make up around 6% of the EMA workforce, excluding contract agents and national experts on secondment. EMA will need to cope with the loss of the staff at a time when its workload is increasing. Applications of non-COVID-19 drugs are growing around 6% a year, according to the agency. COVID-19-related applications and post-authorization activities will add to the rate of growth as well.
 
EMA is already facing resourcing problems. Fee income and associated workload is up 64% since 2014; however, the number of planned staff posts for 2022 is down slightly then. EMA listed work on compassionate use programs, falsified medicines and supervision of active pharmaceutical ingredient manufacturers as areas it is unable to prioritize in 2022 and 2023 because of a lack of capacity.
 
EMA concurrently is looking for ways to increase efficiency. Investment in information management programs is central to EMA’s plans for coping with the anticipated increase in its workload.
 
“The construction of an integrated environment supported by more advanced digital tools will secure the realization of the efficiency gains and set the foundation towards integrated knowledge management envisaged in the Future Proofing of the Agency,” EMA said.
 
EMA Report
 
MDCG posts priority actions for ‘serious challenge’ of IVDR implementation
 
 
The Medical Devices Coordination Group (MDCG) has set out the actions it thinks the EU needs to address the “serious challenge” of implementing the In Vitro Diagnostic Regulation (IVDR).
 
Switching to a staggered implementation bought the EU and IVD manufacturers more time to adapt to the new requirements. However, MDCG remains concerned and is calling for the European Commission and EU member states to “further step up their efforts and work closely together.” MDCG wants to help the stakeholders decide where to focus their limited resources to prevent near-term disruption.
 
The priority actions are unchanged from the joint plan MDCG released late last year, with contingency planning steps and work to increase the availability of notified bodies again topping the group’s list of objectives. MDCG has updated the text based on the new timeline and progress on key initiatives.
 
Notably, MDCG is now targeting a first quarter 2022 publication of guidance on “significant changes,” having previously listed the timeline as to be confirmed. The industry has repeatedly called for the publication of the guidance, which will shed light on which changes manufacturers of legacy IVDs can make without undergoing conformity assessment, before the May 2022 IVDR date of application.
 
Other changes include the removal of target timelines for discussions about notified body capacity and EU reference laboratories, which were previously set to the fourth and first quarter of 2021, respectively. MDCG now lists both discussions as “continuous.” The group also updated the status of the notified body discussion to “ongoing.” Previously, that status was left blank.
 
MDCG Plan
 
EMA starts asking companies whether marketing cessations could cause shortages
 
EMA has updated its post-authorization procedural advice for users of the centralized procedure with new information about the product details marketing authorization holders (MAHs) need to report.
 
EMA notes it will ask MAHs that report marketing cessations whether they anticipate a risk of shortage. EMA expects MAHs to answer to the best of their knowledge at that time. The request is “intended to facilitate dissemination of the information within EMA and EU Network” and is in addition to existing processes for reporting shortages.
 
EMA also answered a new question about when and how to report actions taken in third countries. The agency’s response clarifies that MAHs must notify it of overseas actions to suspend, withdraw or request the withdrawal of a marketing authorization over quality, safety or efficacy issues. Currently, MAHs need to email EMA. The agency plans to include the notifications in its IRIS online platform.
 
EMA Q&A
 
EMA starts work on center for the DARWIN EU
 
EMA has begun work to set up its coordination center for the Data Analysis and Real World Interrogation Network (DARWIN EU) in collaboration with Erasmus University Medical Center, Rotterdam.
 
DARWIN EU, the priority deliverable of EMA’s big data workplan, is intended to give the agency and member states access to “valid and trustworthy real-world evidence.” The coordination center’s role is to develop and manage a network of real-world healthcare data sources and to conduct scientific studies, initially at the request of regulators but later in response to stakeholder requests.
 
EMA expects DARWIN EU to deliver its first pilot studies this year. The agency will oversee the coordination center, connect it to the work of EMA medicines committees and monitor its performance. Erasmus University is setting up the coordination center’s infrastructure and business services under the terms of a contract EMA put out for tender in June.
 
Press Release
 
France pressures Philips to replace recalled respiratory devices
 
The French National Agency for Medicines and Health Products Safety (ANSM) is calling for Philips to accelerate the replacement of recalled ventilators and continuous positive airway pressure (CPAP) devices.
 
Philips began a global recall in June in response to a potential problem with the sound-absorbing foam used in the devices. The recall affects 370,000 patients in France. By repairing some devices and replacing others, Philips aims to finish the recall in the fourth quarter of 2022.
 
As of 04 February, Philips had replaced 7% of the affected devices, according to ANSM, leading the agency to call for the company to accelerate the process. ANSM’s notice states Philips is replacing the defective devices in France and makes no mention of repairs.
 
ANSM Notice (French)
 
Other news:
 
The European Directorate for the Quality of Medicines (EDQM) has reminded Certificate of Suitability (CEP) holders of their obligations to marketing  authorization holders. EDQM said “recent issues have demonstrated the lack of knowledge of some CEP holders regarding those obligations,” leading it to create a guidance document summarizing the responsibilities. EDQM Notice
 

 

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