Expert comment: EMA board October meeting highlights

The EMA management board had its quarterly meeting on 2 October. There were several interesting topics on the agenda. Some highlights are presented below.

EMA Mid-year report

According to the EMA, reported through their mid-year report, there are less clock-stop extensions which leads to a smoother review process and shorter review times. All in all, good news also for the industry even though the reason for the decrease is that the EMA has “reinforced best practices for requests for clock stop extensions from companies”. Hopefully, this approach still allows for some flexibility in less usual situations.

A few other key figures of note are:

• The number of requests for scientific advice and protocol assistance remain relatively stable with a total of 384 for first half of 2025.
• Marketing authorisation applications for both non-orphan and orphan medicinal products also remain at similar levels compared to last year with a total of 17 non-orphan and 12 orphan applications received for the first half of 2025.
• The number of applications for orphan designation has increased with 11% since the same period for 2024 with a total of 115 applications received.

ICMRA

The EMA has been chairing International Coalition of Medicines Regulatory Authorities (ICMRA) for the last six years, working for regulatory alignment and stronger public health response among other topics. At the recent ICMRA summit with participants from more than 40 medicines regulatory authorities, the Therapeutic Goods Administration (TGA) in Australia was elected as the new chair of the organisation.

ICMRA plays an important role in safeguarding global public health, by sharing information, responding to current and emerging safety challenges, and encouraging greater collaboration and harmonisation among international medicines regulators.

OPEN initiative

The OPEN initiative was initiated during the COVID-19 pandemic and is a data exchange initiative involving the EU, Australia, Brazil, Canada, Japan, Republic of Korea, Switzerland and the WHO. The board agreed to extend the scope of this initiative to also include all medicines that target unmet medical needs and advanced therapy medicines products (ATMPs) and also for post-authorisation changes including new indications. Hopefully this will continue to be a useful initiative for the authorities to support each other and to facilitate approval of these very important products.