Policy· June 30, 2026 · 18 min read
China Drug Trial Data Protection (NMPA 2026 No.47): Exclusivity and BD Strategy
By Ran Chen#China#NMPA#Regulatory
Topic
Regulatory
Regulatory strategy, FDA and EMA submissions, postmarketing requirements, accelerated approval obligations, and lifecycle compliance.
Policy· June 30, 2026 · 18 min read
China's 2026 Medical Representative Measures: Building a Compliant Model
By Ran Chen#China#NMPA#Market Access
Policy· June 21, 2026 · 5 min read
Building the AMCP dossier: a guide to the version 5.0 format and value evidence template
Global· June 8, 2026 · 11 min read
South Korea MFDS biosimilar reform 2026: what US launch teams need to know
By Ran Chen#Biosimilars#Regulatory#FDA Approval
Manufacturing· May 22, 2026 · 10 min read
Analytical Method Transfer Acceptance Criteria for a New Release-Testing Lab
By Ran Chen#CMC#FDA#Regulatory
Manufacturing· May 22, 2026 · 13 min read
API supplier change control: DMF letter-of-authorization and notification traps
Manufacturing· May 22, 2026 · 10 min read
CDMO quality agreement red flags that become FDA inspection findings
By Ran Chen#Manufacturing Capacity#CMC#FDA Approval
Manufacturing· May 22, 2026 · 14 min read
CMC-only complete response letters: how commercial teams should read the risk
By Ran Chen#Manufacturing Capacity#CMC#FDA Approval
Manufacturing· May 22, 2026 · 12 min read
eCTD Module 3 lifecycle hygiene after multiple post-approval supplements
By Ran Chen#CMC#Post-Approval Changes#ICH
Manufacturing· May 22, 2026 · 12 min read
Global CMC change classification mismatch between FDA, EMA, and non-ICH markets
By Ran Chen#CMC#Post-Approval Changes#ICH