Home > Newsletters > FDAnews Drug Daily Bulletin > EMA Offers Guidance on Marketing Applications for Transdermal Patches
FDAnews Drug Daily Bulletin
Oct. 23, 2012 | Vol. 9 No. 208
EMA Offers Guidance on Marketing Applications for Transdermal Patches
Manufacturers of transdermal patches should minimize the amount of residual drug substance in the patch as much as possible to avoid patient and environmental safety risks, according to a new European Medicines Agency (EMA) draft guideline. An excess of drug substances in transdermal patches is common, because the excess is necessary to deliver the drug at a clinically effective rate over time, the EMA notes. However, the risk of crystallization during storage could adversely affect the product’s quality and efficacy.
International Pharmaceutical Regulatory Monitor
ePublishing :: CMS, Hosting & Web Development | © Copyright by FDAnewsAll rights reserved. Do not duplicate or redistribute in any form.