Guidelines

2023-10-15

Medical Devices Guide

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

2023-09-28

Medical Devices Guide

Guidance on SFDA Requirements for Quality Assurance Programs for Radiation Emitting and Imaging Devices (MDS-G15)

2023-09-21

Drugs Guide

Product Recall Guidance

2023-08-06

Drugs Guide

Child resistant packaging requirements

2023-07-09

Drugs Guide

Clinical Considerations for Efficacy and Safety Assessment

2023-06-04

Drugs Guide

Guidance for Orphan Drug Designation

2023-06-01

Drugs Guide

Guideline on the Braille Requirements for Labeling Information of Medicinal Products for Human Use

2023-04-04

Drugs Guide

Guidance on Submission of Chemistry, Manufacturing, and Control (CMC) Information for Cell-based Clinical Trial Applications

2023-03-29

Drugs Guide

Specifications: Test Procedures and Acceptance Criteria for New Veterinary Drug Substances and New Medicinal Products: Chemical Substances (VICH GL39)