Guidelines

Guidance for Orphan Drug Designation

Guidance for Paracetamol-Containing Oral Liquid Dosage Forms Products Intended for Pediatrics

Guidance for Presenting PIL and Labeling Information of Herbal and Health Products

Guidance for Presenting the Labeling Information, SPC and PIL

Guidance for Priority Review of Product Registration

Guidance for Submission

Guidance for Surgical Sutures (MDS-G021)

Guidance for the operation and use of radiation emitting medical devices (MDS – G007)

Guidance for the Preparation of a Site Master File (SMF)

Guidance for Veterinary Good Clinical Practice VICH GL9

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

Guidance on Adverse Drug Events Reporting for Healthcare Professionals