Euro Roundup: EMA reviews its response to the COVID-19 pandemic

A new report from the European Medicines Agency (EMA) offers a self-assessment of how the agency responded to the COVID-19 pandemic, from March 2020 to early May 2023 when the World Health Organization ended the Public Health Emergency of International Concern.

The report highlights the development, support, and authorization of vaccines as an essential part of EMA’s response. The agency’s main achievements in that area included:

providing enhanced free pre-submission dialogue with companies for more than 150 COVID-19 vaccines and treatments;
conducting “agile assessments” of promising candidate vaccines and treatments, leading to the approval of eight vaccines, four adapted vaccines, and eight new therapeutics;
enabling rapid reviews of changes for expansion of supply capacity; and
providing safety monitoring through the EudraVigilance system, which received 1.7 million reports for COVID-19 vaccines from healthcare professionals and vaccinated individuals in Europe.

During the pandemic, EMA also took on a larger role in handling medicine shortages. Prior to the pandemic, medicine shortages were primarily a national competence but as the number of shortages of critical medicines grew, the EMA began working with member states’ regulatory authorities and the European Commission (EC) to set up an executive steering group on shortages caused by major events and to develop a common framework for forecasting demand data in the EU. EMA also launched the industry-Single Point of Contact (i-SPOC) system to streamline the gathering of information by pharmaceutical companies on shortages.

“The handling of this pandemic and the important input provided by EMA, supported by the regulatory authorities of the member states and the EU institutions, was overall a great success,” the report states. “However, there is no reason to be complacent and to consider that the next public health crisis, and in particular a new pandemic, can be managed by simply copying and pasting the current crisis handling. It will be important for all decision-makers to be vigilant and to act timely and decisively to adjust current crisis arrangements whenever needed.”
EMA Report

EMA to review data on paternal exposure to valproate

The EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) is conducting a review of data on the possible risk of neurodevelopmental disorders among children whose fathers took valproate medicines.

Valproate is an anti-seizure medicine that can also be used in bipolar disorder and there is already a recommendation to avoid exposure to the drug in women during pregnancy because of the risk of birth defects and neurodevelopmental disorders. Most recently, initial results from an industry-sponsored postauthorization safety study may indicate an increased risk of neurodevelopmental disorders in children born to men taking valproate in the 3 months before conception.

However, PRAC noted that the retrospective observational study that raised this safety signal has important limitations, such as issues with the definition of neurodevelopmental disorders and some database errors. As a result, PRAC requested that the companies involved in the study provide analyses of corrected data and additional information to address the limitations. PRAC will review the data and make an EU-wide recommendation.

In the meantime, men taking valproate are advised not to stop their medication without talking to their physician since sudden discontinuation of epilepsy treatment could trigger seizures.

PRAC Review

MHRA analysis finds UK-sourced plasma safe for albumin manufacture

The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has determined that the use of UK-sourced plasma in the manufacture of albumin medicine products poses “no or minimal additional risk” of variant Creutzfeld-Jakob disease (vCJD).

The analysis, published on 15 August, was carried out as demand for albumins has increased and blood donations have decreased. There has been a UK ban on the use of UK-sourced plasma in the manufacturing of plasma-derived medicine products since 1999 as a precaution against transmission of vCJD. In 2020, the ban on the manufacture of immunoglobulins was reversed after a review by the MHRA showed that the practice was safe.

In the current review for albumin manufacture, the MHRA assessed the prion reduction factors (PRFs) obtained from pharmaceutical manufacturers of albumin medicine products in the UK and found a range from 5.7 to 12.7 Log, which was within the range of data obtained for immunoglobulins. Additionally, the UK National CJD Research & Surveillance Unit at the University of Edinburgh suggested that previous risk estimates for use of UK plasma in albumins were too high and that there is “negligible risk.”

The findings from the MHRA analysis were originally presented to the UK Commission on Human Medicines in October 2022 for its review.

MHRA Report

EMA plans workshops on AI and accelerating clinical trials

The EMA will host a joint workshop with the Heads of Medicines Agency (HMA) on artificial intelligence developments in technology, policy, and the potential application in medicines regulation. The meeting, which will be held 20-21 November, will build on topics discussed at the HMA/EMA workshop on AI held in 2021.

EMA also has planned a workshop on accelerating clinical trials in the EU, which will focus on the development of methodologies (Priority Action 8). The multi-stakeholder methodology workshop will be held on 23 November and will focus on stakeholder perspective on the development of clinical trial methodology guidance, the current status of guidance, and identifying methodology areas for new guidance or updates.

AI Workshop

Accelerating Clinical Trials Workshop

Noël Wathion, former EMA deputy executive director, dies at age 66

Noël Wathion, who retired from the EMA in 2021 as the Deputy Executive Director, died on 12 August. He was 66.

Wathion was a Belgian national and a pharmacist by training who had a 30-year career in public health in the EU. During his career, he supported five executive directors and held various roles in EMA and in a national capacity. He was known as a skilled crisis manager and a tough negotiator and is credited with steering the EMA through challenging times, including Brexit and the COVID-19 pandemic.

“Noël stood for everything that is best about EMA and the European Union. He was passionate about public health, he cared about people, and he was deeply committed to the European idea,” Emer Cooke, EMA executive director, said in a statement. “We have lost a dear friend, who has touched the lives of so many.”

EMA Statement

Euro Roundup: EMA reviews its response to the COVID-19 pandemic

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