Vibha is a senior writer covering pharmaceutical and medtech regulatory developments across the globe. She plays a key role in tracking and writing about news of important regulatory issues affecting the sectors, and explaining their implications for industry. Vibha's fields of interest include the EU regulations on clinical trials, pharmacovigilance and pediatrics, on which she has written several exclusive articles from various industry conferences. She has also commissioned some pieces of expert analysis on major developments in the pharma and medtech regulatory arenas.
Latest from Vibha Sharma
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 UK’s Health Research Authority has updated its General Data Protection Regulation “transparency wording template” with more information on how data about research participants would be handled if it is sent abroad.
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.
The European Medicines Agency’s executive director said the current practice of companies frequently changing their planned dates for submitting their marketing submission via the centralized procedure was “playing havoc” and was “detrimental to the system.”