Guidelines

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)

2025-03-25

Drugs Guide

Guidelines for Variation Requirements

2025-03-23

Medical Devices Guide

Guidance on Companion Diagnostic IVDs (MDS-G026)

2025-02-02

Drugs Guide

Regulation and Requirements for Conducting Clinical Trials on Drug

2025-01-30

Medical Devices Guide

Guidance on Innovative Medical Devices (MDS – G002)

2025-01-28

Drugs Guide

Impurities in New Veterinary Drug Substances

2025-01-28

Drugs Guide

Impurities in New Veterinary Medicinal Product