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MHRA draft guideline on the use of external control arms based on real-world data to support regulatory decisions

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2. Consultation on the Revised International Council for Harmonisation Guideline M4Q(R2)
3. MHRA Real-World Evidence Scientific Dialogue Programme
4. Consultation on the International Council for Harmonisation (ICH) E21 Guideline on the Inclusion of Pregnant and Breast-feeding Individuals in Clinical Trials
5. MHRA launches Route B notification pilot as part of clinical trials regulations rollout