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International Regulators Say Collaboration Is Key To Tackling Pharma Globalization Challenges

 
• By Eliza Slawther

Regulators from Canada, the UK and Australia discuss their experiences of working together under both the ACCESS Consortium, an international regulatory worksharing coalition, and Project Orbis, a parallel review process designed to speed up access to oncology medicines.

Global Medicines
• Source: Shutterstock

Cross-border regulatory collaborations, such as the five-country ACCESS Consortium, are crucial in meeting the growing challenges posed by increased globalization in health care, according to Canada’s medicines regulator, Health Canada.

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Making EU Clinical Trials Regulation A Success ‘Takes All Of Us To Tango’

 
• By Eliza Slawther

Sponsors and regulatory agencies within the 27 EU member states must all be “committed” to working with the EU Clinical Trials Regulation in the most appropriate way to keep pace with other countries, including the UK where competition is heating up, says Miguel Forte, CEO of Kiji Therapeutics.

EU Biosimilar Filings, Opinions And Approvals

 
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Industry Highlights Issues With EU HTA Regulation’s PICO Framework For Vaccines

 
• By Eliza Slawther

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EU HTA Regulation: Don’t Forget About Vaccines, Industry Warns

 
• By Eliza Slawther

Europe’s vaccines industry wants to make sure immunizations “are not forgotten” by policymakers who are overseeing the EU Health Technology Assessment Regulation. It has highlighted several nuances of vaccines that should be addressed over the coming years.

More from Geography

Making EU Clinical Trials Regulation A Success ‘Takes All Of Us To Tango’

 
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Sponsors and regulatory agencies within the 27 EU member states must all be “committed” to working with the EU Clinical Trials Regulation in the most appropriate way to keep pace with other countries, including the UK where competition is heating up, says Miguel Forte, CEO of Kiji Therapeutics.

ICH Modernizes Stability Testing Guideline

 
• By Vibha Sharma

The International Council for Harmonisation has consolidated and modernized its existing stability guidelines into one document, and addressed modern stability testing approaches like modeling, bracketing, and matrixing.

EU Biosimilar Filings, Opinions And Approvals

 
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