Bibliographical Application
Navigating Global Regulations with Precision while Uncovering Drug Discovery through Expert Bibliographic Applications
Navigating Global Regulations with Precision while Uncovering Drug Discovery through Expert Bibliographic Applications
Ensuring international regulatory norms is crucial in the pharmaceutical sector, and bibliographic applications are vital in providing reliable and current information to support regulatory procedures.
Article 10a of Directive 2001/83/EC and Section 22(3)(1) of the German Medicines Act require submission of data for Modules 1 through 3. If a medicinal product’s active ingredients have been used for at least ten years in the Union with recognized efficacy and safety, pre-clinical and clinical trials can be replaced with specific references to published scientific literature. A comprehensive scientific bibliography covering all preclinical and clinical features is necessary for this evidence. For this purpose, this form of application is termed as bibliographical application.
The type of literature sources and content are crucial for a bibliographic application, as submitted work must be published by a reliable source and freely available in public domain. The data from own preclinical and clinical research may not be considered in the bibliographical application. Assessment reports, like EPAR for EU marketing authorizations or summary reports from competent authorities cannot be considered for transparency reasons. To establish the effectiveness and safety of a medical product, applicants must include both positive and negative literature data in their evidence and explain any missing information in a contentious manner.
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