EU Regulatory Roundup: MEB becomes a cornerstone of EMA assessments

| 28 May 2020 | By Nick Paul Taylor 

The Dutch Medicines Evaluation Board (MEB) has increased its share of European human rapporteur and co-rapporteur cases to become the dominant force in the centralized authorization procedure.
After Amsterdam was identified as the European Medicine Agency’s (EMA) next home, MEB began collaborating with regulators in other Member States to ensure work previously performed by the United Kingdom could be spread across multiple agencies. The initiative was intended to spare MEB from the need to significantly grow its capacity and ensure the more equitable distribution of work.
However, European-level data published by the Danish Medicines Agency (DKMA) show that in 2019 MEB took on far more human rapporteurships and co-rapporteurships than its peers. The number of cases handled by MEB rose from less than 25 to more than 35 from 2018 to 2019. In taking on the extra work, MEB increased its share of all cases from 10% to 13%.
In 2016, the last year before Brexit started to drive down the workload of the Medicines and Healthcare products Regulatory Agency, the UK handled 40 cases through the centralized procedure, just a few more than MEB took on last year. The UK took on 15% of all cases in 2016. Back then, MEB handled less than 20 cases, or 6% of all submissions through the centralized procedure.
While MEB has come to become almost as important as MHRA was to the centralized procedure, the plan to get other agencies to take on more work has seen some success. In 2016, MHRA was one of three agencies that covered at least 20 cases through the centralized procedure. Last year, MEB was one of six agencies that performed that much work.
Beyond the rise of MEB and disappearance of MHRA, the period has been characterized by a decline in Germany’s contribution and the emergence of DKMA has a major player. Germany handled 35 cases in 2016, accounting for 13% of all the work; those numbers were 25 cases and 9% of the total last year. Over the same period, the proportion of cases handled by DKMA increased from 3% to 7%, making the agency the joint third most active regulator in 2019.
Annual Statistics
EMA starts preparations for real-world monitoring of COVID-19 vaccines
EMA has tasked Utrecht University in the Netherlands with researching data sources and methods that could enable monitoring of the safety, effectiveness and coverage of COVID-19 vaccines once they come to market.
The push to make a COVID-19 vaccine available as soon as possible and the need to immunize whole countries could result in an undertested intervention being administered to millions of people. EMA has vowed to only authorize a COVID-19 vaccine after seeing “strong evidence” from trials, but, even so, approved products may be quickly given to many times more people in the real world than they were during development.
Postmarketing monitoring could mitigate some of the risks associated with the rapid rollout of a vaccine; however, EMA wants to establish additional monitoring capabilities.
Utrecht University will work with its University Medical Center Utrecht on “vACcine Covid-19 monitoring readinESS,” also known as the ACCESS project.
Through the project, EMA will build a picture of the health insurance records, medical reports and other data sources that could show how COVID-19 vaccines are performing in the real world. EMA also wants its collaborators to identify adverse events that the monitoring program should pay attention to.
The European project is part of a global effort to monitor the postmarket performance of COVID-19 vaccines. EMA sees its research as complementary to a collaboration agreed by the International Coalition of Medicines Regulatory Authorities.
EMA Notice
Spain gives medtech companies another 11 months to adapt to Brexit
The Spanish Agency of Medicines and Medical Devices (AEMPS) has pushed back the deadline for changing the labelling and instructions for use of medical devices due to Brexit.
In April, AEMPS told medical device manufacturers that used notified bodies in the UK they would need to make changes to their labels, for example by updating details of the authorized representatives. That notice set the date of the UK’s departure from the European Union as the key deadline, but in November AEMPS gave manufacturers more time to change their labels.
Now, AEMPS has again granted the industry more time, moving the deadline to late May 2021. In explaining the delay, AEMPS said COVID-19 has exacerbated the challenge of making the changes, leading it to conclude that companies need more time.
AEMPS Notice (Spanish)
Hydroxychloroquine trials suspended; emergency authorization revoked
The French National Agency for Medicines and Health Products Safety (ANSM) has suspended enrollment in COVID-19 clinical trials of hydroxychloroquine. ANSM has authorized 16 clinical trials of the drug since the start of the coronavirus outbreak.
French researchers, notably Didier Raoult, played a big role in the emergence of hydroxychloroquine as a potential treatment for COVID-19. However, with the World Health Organization stopping the hydroxychloroquine arm of its SOLIDARITY trial in response to a paper published in The Lancet, France has taken a tougher stance against the drug.
On Tuesday, ANSM suspended enrollment in hydroxychloroquine clinical trials pending new data on its use in COVID-19 patients. Clinical trial participants already taking hydroxychloroquine can continue to do so.
Separately, the French government repealed a decree that cleared physicians to prescribe hydroxychloroquine for use in the treatment of COVID-19. The action followed a government request for input from the National Council for Public Health on whether to continue to permit the emergency use of hydroxychloroquine.
In Italy, Agenzia Italiana del Farmaco (AIFA) on 26 May suspended the use of hydroxychloroquine outside of clinical trials based on new evidence from observational studies that indicate “an increased risk for adverse reactions in the face of little or no benefit.”
ANSM Notice, Government Decree (both French)
Germany folds medical information regulator into drug and device agency
Germany has merged the “major functional units” of the Institute for Medical Documentation and Information (DIMDI) into its drug and medical device regulatory agency.
DIMDI handles the classification and management of medical information in Germany, for example by encoding disease diagnoses for use in remuneration and financing systems. Last summer, the German Ministry of Health disclosed plans to merge DIMDI with the Federal Institute for Drugs and Medical Devices to pool the agencies’ resources and expertise.
The merger formally happened this week. In disclosing the merger, DIMDI talked up the ability of the combined organization to seize opportunities related to the digitization of the healthcare system.
DIMDI Notice
Other News:
The Swiss Agency for Therapeutic Products (Swissmedic) has published a list of 19 products that are covered by legislation intended to stop COVID-19 from causing shortages. Swissmedic is allowing companies to temporarily import products originally intended for use in other countries to ensure their availability in Switzerland. Hydroxychloroquine and lopinavir–ritonavir, therapies studied in the treatment of COVID-19, are on the list. Swissmedic Notice
Spain’s AEMPS has published advice to mitigate the risk that the misuse of antibiotics in the context of COVID-19 will accelerate the emergence of drug-resistant bacteria. AEMPS wants physicians to not give antibiotics prophylactically to prevent bacterial pneumonia. The advice is part of a wider approach to the use of antibiotics advocated by the regulator. AEMPS Notice (Spanish)


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