Euro Roundup: EMA publishes work plan for Big Data Steering Group - Regulatory Focus

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The European Medicines Agency (EMA) has published the work plan for its Big Data Steering Group, listing the actions the group will take to fulfill its mission to advise EMA and the Heads of Medicines Agencies (HMA) about how to implement 10 priority recommendations.
 
EMA and HMA established the steering group in February. The group first met in May and has now shared an overview of the tasks that will occupy it through to early 2022.
 
The work plan is broken up into activities that address 10 priority recommendations. In the view of the steering group, the Data Analytics and Real-World Interrogation Network (DARWIN-EU), a proposed platform for accessing and analyzing healthcare data from across the European Union, is the most ambitious of the recommendations. The work plan calls for the creation of a draft plan for the project by November and a funding strategy in January.
 
The steering group will work toward those targets while handing other activities related to the nine other recommendations. Work to improve the big data skills of the EU regulatory network and establish a governance framework are underway.
 
More activities are set to begin later in the year and in 2021. In July 2021, the steering group aims to pilot patient-level data analysis for new marketing authorization applications. The pilot is part of a push to address the need for technology capable of enabling the desired analytics capabilities. The steering group is scheduled to review the pilot project in March 2022.
 
While the work plan sets specific months for projects to start and finish, EMA said the steering group may need to reschedule some tasks and will be flexible in the implementation of the plan. The need for flexibility reflects the potential for COVID-19 to hinder the steering group’s ability to carry out its activities.
 
The steering group is set to gather feedback on the plan and its implementation at a virtual event late in 2020. EMA said the big data strategy will also feature collaboration with bodies based outside of the EU.
 
Work Plan, Press Release
 
Spain’s AEMPS posts COVID control advice for biopharma
 
The Spanish Agency of Medicines and Medical Devices (AEMPS) has published recommendations for how drug manufacturers and distributors can stop COVID-19 infections from disrupting their work.
 
Spain needs biopharma supply chains to continue functioning to ensure the continued availability of essential medicines. COVID-19 poses a threat to those supply chains as outbreaks at companies may cause disruption that stops products from reaching patients.
 
AEMPS is advising companies to follow up confirmed cases of infection among employees with contact tracing. Employees who met infected coworkers should only return to work after receiving a negative PCR test result for SARS-CoV-2.
 
The agency wants companies to impose that policy as part of a broader prevention plan for their sites. AEMPS recommends companies regularly update their plans and consult the latest materials from the Spanish Ministry of Health when doing so.
 
AEMPS Notice (Spanish)
 
Ireland’s HPRA revises guidance on wholesaling and GDPs
 
Ireland’s Health Products Regulatory Authority (HPRA) has updated its guides to good distribution practices (GDPs) and the wholesaling and brokering of medicinal products for human use.
 
HPRA made multiple changes to each document. The GDP guide now includes a section on part-time responsible persons (RPs). HPRA will permit the use of part-time RPs provided they are continuously contactable, present at the site often enough to perform their duties and able to maintain oversight of their responsibilities when they are not present in person.
 
The GDP guide also features another new section on the sourcing of exempt medicinal products that explains the effect of regulatory changes passed last year. The regulations permit wholesalers to get exempt medicinal products directly from outside the EU only if they check they are authorized to do so before acting.
 
In updating the wholesaling and brokering guide, HPRA has added new regulations to the list of texts that provide the legislative basis for the advice. The safety features regulations and amendment to the obligations on holders of wholesaler’s authorizations are the two new legislative documents.
 
GDP Guide, Wholesale Guide
 
Dutch MEB acts to ensure Pentothal availability ahead of Hospira exit
 
The Dutch Medicines Evaluation Board (MEB) is calling for companies to take over the license for the anesthetic drug Pentothal. Hospira, the current license holder, plans to withdraw from the market at the end of the year for economic reasons.
 
Pentothal was used in lethal injections in the US, leading Hospira to say it was stopping production almost a decade ago amid concerns it would be impossible to stop it being used for that purpose. Yet, Hospira still has a Dutch license for the 500 mg powder for injection version of the drug. That is set to change at the end of the year when Hospira wants the license to be cancelled.
 
As the drug has uses in brain surgery and other procedures, MEB wants other companies to step in and take over the license. In the interim, MEB expects parallel imports of thiopental, the active ingredient in Pentothal, from other European Union countries to meet the needs of the Netherlands.
 
MEB Notice (Dutch)
 
France’s ANSM holds public consultation on Sanofi progesterone drug
 
The French National Agency for Medicines and Health Products Safety (ANSM) has begun a public consultation to gather views on a progesterone drug sold by Sanofi as Lutéran and similar medicines. Women use the drugs for birth control, menopausal hormone therapy and other reasons.
 
ANSM has worked to manage the risk of meningioma brain tumors in patients taking Lutéran, Lutenyl and their generics for several years. Now, in the wake of a study that shed further light on the risk, ANSM is convening a meeting to gather the views of patients and healthcare professionals about the drugs. ANSM is soliciting written contributions and holding an event in early November.
 
The consultation will address preliminary recommendations for the use and monitoring of the drugs that ANSM published earlier in the year. ANSM formulated the recommendations in light of evidence of how the dose and duration of treatment, plus the patient’s age, affect the level of risk.
 
ANSM Notice (French)
 
Other News:
 
The Swiss Agency for Therapeutic Products (Swissmedic) has published a warning about supposedly herbal products. Swissmedic tests found the products contain undeclared synthetic pharmaceutical substances including sildenafil (Viagra). Some of the products contained a “massive overdosage” of a pharmaceutical ingredient, Swissmedic said. Swissmedic Notice The Link Lonk


September 18, 2020 at 03:11AM
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Euro Roundup: EMA publishes work plan for Big Data Steering Group - Regulatory Focus

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