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Este documento es una directriz armonizada por ICH sobre la gestión de datos de seguridad clínica, proporcionando una estructura para la transmisión de informes de seguridad individual de casos.
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What is ich harmonised tripartite guideline?
The ICH Harmonised Tripartite Guideline is a set of international guidelines developed by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) to provide regulatory authorities with guidance on the development, registration, and post-approval of pharmaceutical products.
Who is required to file ich harmonised tripartite guideline?
Pharmaceutical companies and manufacturers are usually required to file the ICH Harmonised Tripartite Guideline when seeking approval for the development, registration, or post-approval of their pharmaceutical products in respective regulatory jurisdictions.
What is the purpose of ich harmonised tripartite guideline?
The purpose of the ICH Harmonised Tripartite Guideline is to harmonize the technical requirements and regulatory standards for the development, registration, and post-approval of pharmaceutical products across different regulatory jurisdictions. It aims to facilitate global harmonization and ensure the quality, safety, and efficacy of pharmaceutical products while minimizing the need for redundant testing and unnecessary delays in the approval process.
What information must be reported on ich harmonised tripartite guideline?
The specific information that must be reported on the ICH Harmonised Tripartite Guideline may vary depending on the type of pharmaceutical product and the regulatory jurisdiction. However, it typically includes information regarding the manufacturing process, quality control, stability, nonclinical and clinical studies, adverse reactions, labeling, and packaging of the pharmaceutical product.
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