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ICH has produced a comprehensive set of safety Guidelines to uncover potential risks like carcinogenicity, genotoxicity and reprotoxicity. A recent breakthrough has been a non-clinical testing strategy for assessing the QT interval prolongation liability: the single most important cause of drug withdrawals in recent years.
The ICH Q2(R2) revised Guideline and the Q14 Guideline reached Step 4 of the ICH process on 1 November 2023. The Q2(R2)/Q14 EWG developed a new ICH Quality Guideline, ICH Q14, on Analytical Procedure Development, and revised the ICH Q2(R1) Guideline on Validation of Analytical Procedures.
The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) is unique in bringing together the regulatory authorities and pharmaceutical industry to discuss scientific and technical aspects of pharmaceuticals and develop ICH guidelines.
This International Conference on Harmonization (ICH) guidance provides a unified standard for the European Union, Japan, and the United States to facilitate the mutual acceptance of clinical...
ICH HARMONISED GUIDELINE QUALITY RISK MANAGEMENT Q9(R1) Final version Adopted on 18 January 2023 This Guideline has been developed by the appropriate ICH Expert Working Group and has been subject to consultation by the regulatory parties, in accordance with the ICH Process. At Step 4
The European Medicines Agency publishes scientific guidelines on human medicines that are harmonised by the International Council for Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH).
The concepts outlined in prior ICH Quality Guidelines (ICH Q8 (R2), Q9, Q10 and Q11) provide opportunities for science- and riskbased approaches - for use in drug development and regulatory decisions.
The following guideline is a revised version of the ICH Q1A guideline and defines the stability data package for a new drug substance or drug product that is sufficient for a registration application within the three regions of the EC, Japan, and the United
Oct 14, 2019 · The ICH E2D guideline provides guidance on definitions and standards for post-approval individual case safety reporting, as well as good case management practices.
The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use ( ICH) is an initiative that brings together regulatory authorities and pharmaceutical industry to discuss scientific and technical aspects of pharmaceutical product development and registration. The mission of the ICH is to promote public ...
