SQA

MAY 6, 2025

SQA Regulatory Surveillance Summary for 3Q/4Q 2024 By: Laurel Hacche and Debra Cortner As we move through 2025, looking back at regulatory updates from Q3 and Q4 of 2024 provides critical insight into how the global compliance landscape is evolving. However, in practice, the NMPA expects compliance with industrial standards.

US Department of Health and Human Services 52

US Department of Health and Human Services FDA Compliance Licensing 52

SQA

FEBRUARY 15, 2023

A new template for the Certificate of a Pharmaceutical Product will be put into use in line with China’s pharmaceutical export practices and the latest World Health Organization (WHO) guidelines. The electronic certificate and the paper version are equally authentic.

US Department of Health and Human Services 40

US Department of Health and Human Services FDA COVID-19 World Health 40

SQA

OCTOBER 18, 2024

Level 2: When a simplified analysis of the EFRA inspection report is performed to evaluate compliance with the GMP requirements and may be adopted unilaterally by ANVISA. The classification criteria include: Serious deficiencies: Typically linked to non-compliance with critical items. Major deficiencies: Associated with major items.

FDA 52

FDA Compliance Public Health World Health 52

SQA

OCTOBER 18, 2024

Level 2: When a simplified analysis of the EFRA inspection report is performed to evaluate compliance with the GMP requirements and may be adopted unilaterally by ANVISA. The classification criteria include: Serious deficiencies: Typically linked to non-compliance with critical items. Major deficiencies: Associated with major items.

FDA 40

FDA Compliance Public Health Governance 40