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UK MHRA Guidance: Access, New Active Substance and Biosimilar Work Sharing Initiatives
Timely access to innovative medicines and biosimilars is an important objective for regulatory authorities worldwide. Collaborative assessment models enable regulators to share scientific expertise, reduce duplication of effort, and accelerate the availability of high-quality, safe, and effective medicines for patients. International work-sharing initiatives also promote regulatory convergence while maintaining robust scientific evaluation standards. The Medicines and Healthc
Sharan Murugan
Jul 123 min read