Guidelines

2025-08-05

Drugs Guide

Guidance for Veterinary Good Clinical Practice VICH GL9

2025-08-04

Drugs Guide

Testing of Residual Moisture

2025-08-03

Drugs Guide

Data Requirements for Human Drugs Submission

2025-07-07

Medical Devices Guide

Guidance on Manufacturing Paths of Medical Devices (MDS-G011)

2025-06-18

Drugs Guide

Guideline on Quality Considerations for Development and Comparability Assessment of Biosimilars

2025-05-21

Medical Devices Guide

Guidance on the development of IVDs for in-house use

2025-05-12

Drugs Guide

Regulatory Guidance for Literature Based Support for Efficacy and Safety of Medicine

2025-05-04

Drugs Guide

Classifying Legal Status of Veterinary Medicinal Products Guidance

2025-03-25

Medical Devices Guide

Guidance for ISO 13485 Requirements and Corresponding SFDA-MDS Requirements (MDS-G024)