EU Finalizes Option To Omit Expiry Date On Inner Labeling Of Investigational Drugs
Executive Summary
Revised labeling requirements for unauthorized investigational and auxiliary medicinal products under the EU Clinical Trial Regulation have been published in the Official Journal.
You may also be interested in...
EU Proposes Changes To Labeling Of Investigational Drugs Under Clinical Trial Regulation
The European Commission is inviting stakeholder feedback on proposals to do away with the need to display the expiry date on the primary packaging of investigational drugs in certain situations.
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.