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In early February, EMA’s Center for Veterinary Medicinal Products (CVMP) has released four draft guidelines and a draft concept paper clarifying recommendations and requirements for animal drug development for minor use and minor species (MUMS). The four guidelines were last updated in 2006/2007. They cover the quality, safety, efficacy, and immunological aspects of the drugs, and are out for comment until the end of July. The concept paper covers pharmacokinetic studies, and has a comment period that ends on April 30. EMA notes that the guidelines are intended to “reduce data requirements where possible for products classified as MUMS/limited market while still providing assurance of the appropriate quality, safety and efficacy.”
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INTERNATIONAL PHARMACEUTICAL QUALITY
Inside the Global Regulatory Dialogue
