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.
US FDA
Pink Sheet reporter and editors discuss potential changes that the incoming Trump Administration could make to the FDA, as well as worries about political interference in decision-making, and policy and staffing changes.
Former Trump adviser Tomas Philipson anticipates the FDA will undergo a deregulatory push during President Trump’s second term and emphasize speeding drugs to market.
Despite the recent anti-vaccine rhetoric in the final weeks of the Trump campaign, pulling an established safe and effective product off market would be difficult. But there’s little to stop political interference in approvals.
OCE Director Rick Pazdur celebrated 25 years at FDA by moderating a panel of five former commissioners. Topics included political challenges with the job and the ‘most memorable’ controversy they faced while in office.