ARTICLE

Understanding the Latest FDA cGMP Regulations

The FDA's current Good Manufacturing Practice (cGMP) regulations set minimum standards for drug manufacturing, processing, and packaging to ensure product safety and efficacy. In April 2026, over 90% of FDA postmarket cGMP...

REGULATORY · APAC

New Guidelines for Drug Approval Processes

APAC regulators have introduced streamlined guidelines aimed at expediting drug approval processes across member countries, focusing on harmonization of standards.

REGULATORY · APAC

Updates on Clinical Trial Regulations

Changes in clinical trial regulations in several APAC countries aim to enhance patient safety and data integrity, with a focus on transparency and reporting.

REGULATORY · APAC

Strengthened Pharmacovigilance Requirements

New pharmacovigilance requirements have been established to improve drug safety monitoring and reporting obligations for pharmaceutical companies operating in the region.

MANUFACTURING · FDA

Inspection Readiness Checklists

Facilities should utilize FDA inspection readiness checklists to ensure compliance with 21 CFR Parts 210 and 211. This includes maintaining proper documentation and training.

MANUFACTURING · FDA

Addressing CAPAs and Deviations

High numbers of open Corrective and Preventive Actions (CAPAs) or repetitive deviations can indicate major quality risks. Addressing these proactively is essential for compliance.

MANUFACTURING · FDA

Focus on High-Risk Components Testing

The FDA's May 2023 guidance emphasizes the importance of testing high-risk components, such as glycerin, for contaminants like diethylene glycol and ethylene glycol.