CTD Module 1
CTD Module 1 is the introductory module of the Common Technical Document (CTD) format, which is used to provide a comprehensive and standardized overview of the quality, safety, and efficacy of a drug product.
Module 1 of the Common Technical Document (CTD) contains administrative information and prescribing information for the product being submitted for regulatory approval. It includes the following components:
- Administrative information: This section contains information about the applicant and the product, including the product name, trade name, active ingredient(s), dosage form, and route of administration.
- Summary of product characteristics (SmPC): The SmPC provides an overview of the product’s properties, including its intended use, indications, contra-indications, warnings, and dosage regimen.
- Patient information leaflet (PIL): The PIL is a document that provides information about the product to patients. It explains how to use the product safely and effectively and highlights any potential risks or side effects.
- Labelling: This section includes the product label and outer packaging, including any graphical elements such as logos and images.
- Description of the proposed clinical trial(s): If the product is intended to be used in clinical trials, this section includes a description of the proposed trial(s), including their design, objectives, and patient population.
Module 1 of the CTD is an important component of the regulatory submission process, as it provides key information about the product and its intended use to the regulatory authorities. This information is critical for evaluating the safety and efficacy of the product and determining whether it should be approved for use in the intended market.
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