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2026
DATE
07 - 27
FDA Updates ANDA Bioequivalence Guidance Aligning with ICH M13A: New Opportunities for Global Generic Drug Development
Loncom Pharma analyzes FDA ANDA bioequivalence updates and supports global generic drug development strategies.
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2026
DATE
07 - 11
NMPA Clarifies Four Priority Review Scenarios for Chemical APIs, Effective August 1, 2026
NMPA's July 2026 announcement specifies four scenarios for chemical API priority review, effective 1 August.
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2026
DATE
07 - 03
ICH Releases E6(R3) Annex 2: Clinical Trial Quality Management Enters the Era of "Decentralised + Real-World Data"
ICH E6(R3) Annex 2 provides GCP guidance for decentralised, pragmatic, and RWD‑enriched trials. It emphasises proportionality, QbD, patient engagement, and early regulator dialogue, reshaping clinical trial quality management for the digital era.
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Shandong Loncom Pharmaceutical Co., Ltd is founded in 2012, located in Qihe Economic Development Zone, Shandong, China

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