Guidelines

2026-03-31

Drugs Guide

Guidelines for Variation Requirements

2026-03-09

Drugs Guide

Guidelines for Chemical and Pharmaceutical Quality Documentation of Small Molecules Investigational Product in Clinical Trial

2026-03-02

The Authority Guide

Guidance for Combination Products Classification

2026-02-02

Drugs Guide

Clinical Considerations for Vaccines

2026-01-20

The Authority Guide

Products Classification Guidance

2026-01-19

Drugs Guide

Guideline for Legal Classification and Distribution Status of Human Medicinal Products

2025-10-30

Drugs Guide

Guidance on Submission of Chemistry, Manufacturing, and Control (CMC) Information for Human Gene Therapy Clinical Trial Application

2025-10-21

Drugs Guide

Economic Evaluation Studies Guidelines

2025-10-20

Drugs Guide

Verification and Abridged Pathways