Global Health Authority Mandates

Saudi Arabia: Pharmaceutical Pricing Mechanisms & Rules (Draft)

Strengthening Price Implementation & Pricing Framework

Published: 20-Nov-2025
Consultation Period: 20-Nov-2025 to 20-Dec-2025
 

Japan- Q&A Regarding the Application of ICH Guidelines to Generic Drugs

The regulatory information addresses the application of ICH guidelines to generic pharmaceuticals, including procedures for consultation, stability testing requirements, and the submission of stability test results.

Japan: Application of ICH Guidelines to Generic Drugs

The regulatory information discusses the application of ICH guidelines to generic pharmaceuticals and other related products, aiming to promote international harmonization of pharmaceutical regulations and clarify review standards for these products.

Effective from- 1st April 2026

China: Announcement No. 40 of 2025 – Release of Reference Preparations List for Generic Drugs (Batch 98)

Strengthening Quality Standards for Generic Drug Development

Effective from 18-Nov-2025

China: Public Notice on Applications for Protection of Traditional Chinese Medicine Varieties

Strengthening Oversight of Traditional Medicine Variety Protection

Effective from 19-Nov-2025