ARTICLE

FDA's New One-Day Inspectional Assessments Pilot Program

The FDA has launched a pilot program for one-day inspectional assessments aimed at streamlining the inspection process for pharmaceutical manufacturers. This initiative is expected to enhance operational efficiency and reduce the burden...

REGULATORY · TGA

TGA Clarifies Manufacturing Licensing for Compounded Medicines

The TGA has issued updated guidance confirming that most compounding sites require a manufacturing licence unless they meet specific exemptions. This guidance reinforces constraints on batch compounding for...

REGULATORY · TGA

Advertising Restrictions on Compounded Medicines

New TGA guidance prohibits the promotion of specific compounded medicines to the public while allowing advertising of compounding services, provided it complies with therapeutic goods legislation.

NEWS

Regulatory Reliance Pathways Tracker Updated

The APACMed Tracker now maps reliance pathways across APAC, detailing which reference markets are accepted for accelerated review of medicines and devices, supporting regional submission strategies.

NEWS

Mutual Recognition Agreement on GMP Signed

The HSA of Singapore and MFDS of Korea have signed a Mutual Recognition Agreement on GMP, enhancing cross-border manufacturing and inspection reliance in the region.

CLINICAL & R&D · PMDA

Distinct Clinical Trial Regulations Across APAC

A review highlights that clinical trial regulations vary significantly across APAC, necessitating local expertise for compliance in markets like Japan, China, and India.