10/ 29/ 2026
China Pharma Plan 2026-2030: Innovation and Global Reach
China published its 15th Five-Year Plan for the pharmaceutical industry on 18 September 2026, setting ten 2030 targets and 25 key tasks on innovation, resilient supply chains and international expansion.
10/ 22/ 2026
ICH M13B Final Guideline: Additional Strength Biowaivers
EMA's final ICH M13B guideline, published 21 September 2026 and effective 17 March 2027, sets the criteria for waiving in vivo bioequivalence studies for additional strengths of immediate-release oral solids.
10/ 19/ 2026
PIC/S GMP Annex 19 Update: Reference and Retention Samples
PIC/S revises GMP Annex 19, clarifying sample retention, repackaging requirements, digital records, and traceability for parallel-traded medicinal products.
