ARTICLE

Singapore HSA Launches eCTD Submissions

As of April 1, 2026, Singapore's Health Sciences Authority (HSA) has officially begun accepting electronic Common Technical Document (eCTD) submissions through its new portal. This marks a significant step towards enhancing regulatory...

REGULATORY · PMDA

New PMDA Guidance on Manufacturing Changes

Japan's PMDA has issued new guidance on categorizing manufacturing changes for marketing applications, emphasizing objective evidence for minor change designations. This aims to streamline the approval process and...

REGULATORY · HSA

HSA-Thai FDA Regulatory Reliance Pilot Phase II Expanded

The regulatory reliance pilot phase II between HSA and Thai FDA has expanded to include Class B, C, D devices and IVDs, building on previous foundations to enhance...

REGULATORY · NMPA

NMPA Joins IMDRF Exchange Programme

The NMPA continues its commitment to regulatory reliance by participating in the IMDRF National Competent Authority Report Exchange Programme, focusing on adverse event sharing and harmonization across APAC.

MANUFACTURING · FDA

Best Practices for FDA Inspection Readiness

Pharmaceutical companies should prioritize comprehensive documentation and staff training to ensure readiness for FDA inspections. Regular mock inspections can also help identify potential compliance gaps.

MANUFACTURING

Importance of Quality Risk Assessment

Implementing quality risk assessments in manufacturing processes is crucial for compliance with PMDA's new guidance. This practice helps in categorizing changes accurately and ensuring product safety.

MANUFACTURING

Streamlining Submission Processes

With the introduction of eCTD submissions by HSA, companies should adapt their submission processes to align with the new standards and ensure timely approvals.