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Posted 02 December 2021 | By Nick Paul Taylor 

Euro Roundup: EMA chief calls for extra staff to handle growing workload

2757 The executive director of the European Medicines Agency (EMA) has told politicians her teams need more support to cope with COVID-19 and their soon-to-be-extended mandate.
 
At a meeting of a European Parliament committee, Emer Cooke addressed questions about whether EMA has enough staff and money to handle its existing workload and the additional activities created by legislation that puts the agency at the heart of a push to strengthen the region’s health security framework. After a seven-year period in which EMA’s activity has risen 43% and its establishment plan has shrunk 10%, Cooke was unequivocal about the need for additional support.
 
“Are we coping? Well, we need help. I think we definitely need help,” Cooke said. “People are working around the clock. Every time we think we've got to the end of a wave, we breathe a sigh of relief, and then another new challenge comes ahead of us. I think we can be confident that we can't rest for a while, so we do need additional human resources.”
 
Cooke said the additional resources are needed to handle COVID-19 work, the publication of clinical trial results, requests to access documents and other activities. EMA’s calls for additional resources have gone unheeded so far, with Cooke expressing disappointment that European Union authorities turned down a request for 20 posts in the work program for 2022.
 
The current situation is affecting the wellbeing of staff, who have undergone the upheavals of moving from London to Amsterdam and the pandemic in quick succession. EMA staff have then had to cope with a jump in their workloads at a time when their professional and personal situations have been transformed by the relocation and COVID-19.
 
“We do know that working in different situations, for some people, this causes additional health and mental strain. This is something we're also seeing from our own staff. We have an increasing number of staff on long-term sick leave. So, we also need a buffer to allow some people to have some rest,” Cooke said.
 
The original legislative package for the extended mandate proposed giving EMA an additional 40 staff and €100 million ($113 million) over a seven-year period. However, the package changed after the European Council and Parliament got involved, notably in regard to the management of shortages. “We still have to evaluate exactly what the resource consequences of that will be,” Cooke said.
 
 
Meeting Replay, Press Release
 
EU adopts implementing regulation on Eudamed medical device database
 
The European Union has adopted an implementing regulation concerning the Eudamed medical device database, providing a framework for how users will access the system, the processing of personal data and more.
 
With parts of Eudamed now online, albeit later than originally expected, the European Commission has published a binding regulation that will apply in all Member States. The regulation is set to enter into force next month, 20 days after its recent publication in the Official Journal of the European Union.
 
The implementing regulation covers multiple parts of the system. In one of the longer sections, EU authorities provide a framework for registering to access Eudamed. Elsewhere, the regulation sets out the actions the Commission will take in the event of a malfunction, explaining that the body will “take all necessary measures to prevent any malfunction and to identify it, without undue delay, when it occurs” and suspend the periods for data submission if the fault affects that function.
 
Implementing Regulation
 
MHRA updates guidance on pharmacovigilance system master files
 
The UK Medicines and Healthcare products Regulatory Agency (MHRA) has updated its guidance on requesting a pharmacovigilance system master file (PSMF) number.
 
MHRA’s prior guidance on pharmacovigilance system requirements provided some information about requesting a UK PSMF number. In updating the guidance, MHRA has added two paragraphs that offer additional advice.
 
“Once a UK PSMF number is assigned to a pharmacovigilance system it should remain unchanged, irrespective of how the system may change and evolve over time. You should not request a new UK PSMF number if there are changes to the pharmacovigilance system, including a change of UK QPPV,” the guidance states.
 
The updated guidance clarifies that companies do not need to update the information they provide online when they request a UK PSMF number, such as their telephone number, because the data is only used to generate and allocate the unique code.
 
MHRA Guidance
 
EU to free COVID-19 vaccine manufacturers from export authorization
 
The EU will let its COVID-19 vaccines export transparency and authorization mechanism expire at the end of the year, freeing manufacturers to ship jabs outside the region without seeking permission.
 
Officials established the mechanism to ensure manufacturers with European operations fulfilled their contracts to supply the EU, rather than shipping their COVID-19 vaccines overseas. Having exported 1.3 billion vaccine doses while meeting local demand, the EU has decided it no longer needs to make manufacturers request authorization to send jabs to other countries.
 
The EU will replace the authorization process with a new monitoring mechanism on 1 January. The monitoring mechanism is designed to provide the Commission with timely, company-specific vaccine export data, enabling it to retain the transparency benefits of the authorization process.
 
EU Member State customs authorities will collect the export data and the Commission will publish it “at an aggregate level.” The Commission said monitoring is needed because of “new outbreaks of the virus in the EU and the risk of new variants of the COVID-19 virus.”
 
Press Release
 
MEB shares advice on upcoming change to drug shortage notifications
 
The Dutch Medicines Evaluation Board (MEB) has published details of its new drug shortage notification process ahead of the switch to the new system at the start of next year.
 
As of 1 January, marketing authorization holders (MAHs) will need to assign a contact person who will submit reports on their behalf. MEB is asking companies to complete the two-step process needed to get set up under the new system by 23 December.
 
First, the MAH needs to send MEB details of the authorized contact person via email. MEB will then send the authorized contact person a link to a registration form. The second step is for the contact person to use the form to register as a reporting party.
 
With MEB taking up to “several working days” to respond to the original email, MAHs have a fairly short window in which to start the process if they are to meet the 23 December deadline. However, MEB will continue to accept urgent notifications using the old form until 17 February.
 
MEB Notice
 
EMA recommends Pfizer COVID-19 vaccine for use in kids aged 5 to 11
 
EMA has recommended the approval of the Pfizer-BioNTech COVID-19 vaccine Comirnaty for use in children from 5 to 11 years of age.
 
The recommendation covers a 10 µg dose, compared to the 30 µg dose used in older children and adults, and is underpinned by a clinical trial showing that quantity of mRNA yielded antibody levels comparable to those seen in young adults. The vaccine was 91% effective at preventing symptomatic COVID-19. 
 
Side effects were similar in the age group and the broader population, with mild-to-moderate pain at the injection site, tiredness and headache among the most common events.
 
EMA Statement

 

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