EMA

Updated guidance issued by the EU regulator explains how to comply with the provisions of the amended Variations Regulation, which will apply to new submissions from January 2025 and is intended to make lifecycle management “more efficient and future-proof.”

Companies that delay their drug application submissions to the European Medicines Agency by more than 60 days will face an additional fees of €4,200 per delay under a new regulation effective from 2025.

The European Medicines Agency is monitoring the frequency with which it must re-appoint experts to assess EU drug filings due to companies' failure to submit their applications as scheduled, thereby disrupting the evaluation process. It warns action may be needed if the “situation worsens.”

EU national competent authorities are stressed about having to put up with an “unacceptably high workload” due to poor submission planning by drug companies when it comes to their EU filings. Poor predictability relating to submissions could also impact industry.

The European Medicines Agency has shared real-life examples of how poor planning by companies results in repeated delays to their planned marketing authorization applications, which in turn causes a drain on resources.

More details on how the EU network of medicines agencies plan to leverage AI and foster competitiveness is now available in their draft 2025-2028 strategy, which they have published for comment.

There is “a lot of flexibility” in the European Medicines Agency’s reflection paper on the use of artificial intelligence during drug development, which is principles-driven rather than setting rigid recommendations, says the agency’s Florian Lasch.

The European Medicines Agency is mulling how best to involve experts in its decision-making processes while avoiding potential conflicts of interest, says executive director Emer Cooke.

Pharmacovigilance experts speaking at an event organized by the European Medicines Agency discussed the rationale behind revised requirements relating to how drug sponsors must develop and evaluate risk minimization measures and thereby improve the safety of their medicines.

The European Medicines Agency has highlighted issues for drug developers to consider when seeking to submit clinical data from SATs as the pivotal evidence in their marketing authorization applications instead of randomized controlled trial data.

Medicines regulators in the EU have “much to gain” from using AI models in their processes, but this technology must be used in a “safe and responsible” way, says the European Medicines Agency.

Nine new entries targeting a wide range of unmet medical needs. Several EU marketing approvals and two withdrawals. And an accelerated assessment tool that was seldom used. These were among the activities noted as part of the European Medicines Agency’s priority medicines scheme during the first half of 2024.

Those involved in the IncreaseNET initiative hope that providing more training for both new and experienced assessors will take the pressure off a regulatory network faced with a growing workload and a shortage of expertise in the face of new scientific developments.