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.
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EU Finalizes Option To Omit Expiry Date On Inner Labeling Of Investigational Drugs
Revised labeling requirements for unauthorized investigational and auxiliary medicinal products under the EU Clinical Trial Regulation have been published in the Official Journal.
Final ICH Guide Supports Nonclinical Development Of Gene Therapy Products
The International Council for Harmonisation has finalized guidance that aims to facilitate the nonclinical and clinical development programs of gene therapy products, while avoiding the unnecessary use of animals.
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Within one year of its establishment, DARWIN EU has started reaping benefits for EU drug regulators commissioning studies using real-world data to better understand diseases, populations and the uses and effects of medicines. The studies can be performed faster, cheaper and at increased capacity.