Guidelines

2025-08-19

Medical Devices Guide

Guidance for the Operation and Use of Radiation-Emitting Medical Devices (MDS–G007)

2025-08-12

Drugs Guide

User Manual for Traveler Clearance Controlled Drug System

2025-08-11

Medical Devices Guide

Guidance on Digital Health Products (MDS-G027)

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