Paper Title
Reviiew on ICH
Article Identifiers
Authors
Thite Nupur Bapu , Raut Pradnya Jaqbaji , Mokate Shivani Kailas
Keywords
• ICH regulatory guideline • Pharmacoepial harmonisation • PSUR (Periodic safety update report) • Good manufacturing practices • Regulatory bodies • Organization of ICH
Abstract
The international council for harmonization (ICH) is the regulatory requirement to confirm the quality safety and efficacy (QSE) of drugs. It brings a union of drug regulatory experts and Pharma business partners from a few countries such as the European union, Japan, and the United States for harmonisation of technical requirements for drugs in humans. The major aim of ICH is to achieve greater harmonisation in the interpretation and application of technical guidelines for the registration of new active substances obtained by biotechnology by its members; to improve the efficacy of global drug development; to reduce redundant studies; to improve pharmacovigilance activity and quality assurance.
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How To Cite (APA)
Thite Nupur Bapu, Raut Pradnya Jaqbaji, & Mokate Shivani Kailas (August-2023). Reviiew on ICH. INTERNATIONAL JOURNAL OF NOVEL RESEARCH AND DEVELOPMENT, 8(8), a131-a139. https://ijnrd.org/papers/IJNRD2308014.pdf
Issue
Volume 8 Issue 8, August-2023
Pages : a131-a139
Other Publication Details
Paper Reg. ID: IJNRD_202501
Published Paper Id: IJNRD2308014
Downloads: 000121979
Research Area: Pharmacy
Country: thane, Maharashtra, india
Published Paper PDF: https://ijnrd.org/papers/IJNRD2308014.pdf
Published Paper URL: https://ijnrd.org/viewpaperforall?paper=IJNRD2308014
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This work is licensed under a Creative Commons Attribution 4.0 International License and The Open Definition
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