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EMA Offers Guidance on Marketing Applications for Transdermal Patches

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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