Commission consults on new types of fees payable to EMA under EU pharmacovigilance law
This article was originally published in SRA
Executive Summary
The European Commission is seeking feedback on new types of fees that drug companies will have to pay to the European Medicines Agency under the provisions of the EU pharmacovigilance legislation1,2. While the fees are critical to the EMA being able to fulfil its new responsibilities under the legislation, it could still be a couple of years before they are in place.
You may also be interested in...
EU Regulatory Assessors Get AI Boost In Reaching Scientific Decisions
The European Medicines Agency is training scientific staff working for the European medicines regulatory network in how to use a new AI-powered search engine that allows them to easily retrieve information on regulatory precedents.
EMA Hopes New Requirement Will Make Companies Stick To Their Filing Plans
An additional form that marketing authorization applicants must now complete during the pre-submission stage emphasizes the importance of companies providing accurate information on their intended submission date.
EMA To Get The Ball Rolling On Making CTIS Global
The European Medicines Agency wants to further improve the visibility of data in the Clinical Trials Information System by establishing it as a World Health Organization primary registry.