International – WHO publishes guidance for HPV vaccine developers to help tackle cervical cancer
Currently the main cause of cervical cancer – the fourth most common cancer in women globally – HPV is a very common group of...
International – ICH releases M11 guideline proposing harmonized template for trial protocols
The International Council for Harmonisation (ICH) has released a draft guideline which outlines a harmonized template for clinical trial protocols to support consistent reporting...
International – ICH adopts guidelines on viral safety evaluation and analytical method development
The International Council for Harmonisation (ICH) announced on 8 November the adoption of its Q5A(R2) guideline on viral safety evaluation of biotechnology products as...
International – Novartis confirms death of 2 children after gene therapy
Novartis has recorded two deaths after treatment with its spinal muscular atrophy gene therapy Zolgensma, once again bringing gene therapy’s safety into attention.
Two children...
International – ICH : Clinical Electronic Structured Harmonised Protocol (CESHARP) M11
The clinical protocol describes the processes and procedures directing the conduct and analysis of a clinical trial of medicinal product(s) in humans. To date,...
International – ICH targets cell and gene therapies, real-world data as topics ripe for...
Officials from Health Canada and the pharmaceutical industry addressed plans to develop harmonized guidelines on cell and gene therapies and on the design of...
International – ICH Guideline Q5A(R2) on viral safety evaluation of biotechnology products derived from...
This guideline concerns the testing and evaluation of the viral safety of biotechnology products, and it outlines what data should be submitted in marketing...
International – ICH adopts M7(R2) guideline on mutagenic impurities to limit carcinogenic risk
The International Council for Harmonisation (ICH) earlier this week announced the adoption of its M7(R2) guideline that aims to harmonize the framework for assessing...
International – ICH S5 (R3) Guideline on detection of reproductive and developmental toxicity for...
The purpose of this document is to recommend international standards for, and promote harmonization of, the assessment of nonclinical developmental and reproductive toxicity (DART)...
International – WHO recommends risk management plans for high-risk excipients
The World Health Organization (WHO) has released two draft appendices to a recent draft guideline on good manufacturing practices (GMPs) for excipients. The first...
