International – Biosimilars, are they comparable to their reference counterparts?
Biologicals such as rituximab and trastuzumab have improved treatment outcomes for many cancers. However, due to their high economic burden, ‘highly similar’ products known...
International – WHO launches R&D efforts to identify pathogens that could cause future pandemics
Disease X represents an unknown pathogen that could have the potential to cause the next global pandemic.
Discussions began on Friday 18 November and WHO...
International – Modular plug-and-produce facilities for cell therapies
At the start of 2021, a crane lifted a shrink-wrapped, elongated structure off a truck flatbed and through a window into an upper floor...
International – ICH M11 guideline, clinical study protocol template and technical specifications
The purpose of this new harmonised guideline is to introduce the clinical protocol template and the technical specification to ensure that protocols are prepared in a...
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 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 advances guidelines on selective reporting of safety data, viral safety
The International Council for Harmonisation (ICH) recently announced the adoption of its E19 guideline, which outlines a risk-based approach for collecting safety data for...
International – ICH guideline S1B(R1) on testing for carcinogenicity of pharmaceuticals Step5
Historically, the regulatory requirements for the assessment of the carcinogenic potential of
pharmaceuticals in the three regions (E.U., Japan, U.S.) provided for the conduct 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 M12: Pharma industry wants clarity on rifampin dosing, more information on...
The pharmaceutical industry would like the International Council for Harmonization (ICH) to clarify dosing information for rifampin and requests additional information on the use...
