Jun 14, 2024 · This document considers testing and evaluation of the viral safety of biotechnology products derived from characterised cell lines of human or animal origin. It outlines data that should be submitted in the marketing application/registration package. Keywords: Viral safety, cell lines qualification, biotechnology, virus clearance.

NGS is used as a limit test and as such, the performance characteristics (specificity/breadth of detection and sensitivity) for method validation/qualification should consider the principles of ICH Q2.

By harmonizing the regulatory expectations in regions around the world, ICH guidelines have substantially reduced duplicative clinical studies, prevented unnecessary animal studies, standardized...

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled “Q5A (R2) Viral Safety Evaluation of Biotechnology Products...

The ICH Q5A(R2) guideline establishes harmonized scientific and technical requirements for products derived from characterized cell lines of human or animal origin:

Dec 12, 2023 · 为推动新修订的ICH指导原则在国内的平稳落地实施，我中心拟定了《<Q5A（R2）：来源于人或动物细胞系生物技术产品的病毒安全性评价>实施建议》，同时组织翻译了Q5A（R2）的中文版。 现对该实施建议和中文版公开征求意见，为期1个月。

This guideline is concerned with testing and evaluation of the viral safety of biotechnology products derived from characterised cell lines of human or animal origin.

The ICH Q5A(R2) Guideline establishes harmonised scientific and technical requirements to fulfill regulatory expectations for testing and evaluation of the viral safety of biotechnology products derived from characterised cell lines of human or animal origin based on scientific progress made since the last revision

Mission History Transparency Funding ICH Award Work with ICH Organisational Chart Members & Observers Value of Membership Application Process Articles & Procedures Work Plans & Reports Process of Harmonisation Public Consultations Guideline Implementation All Guidelines Quality Guidelines Safety Guidelines Efficacy Guidelines Multidisciplinary ...

Sep 29, 2022 · The ICH Q5A (R2) draft Guideline on Viral Safety Evaluation of Biotechnology Products reached Step 2 of the ICH process on 29 September 2022.