Regulatory Blog

The registration of human medicines is a complex process that requires comprehensive scientific evidence demonstrating that a product is safe, effective, and manufactured to acceptable quality standards. To support applicants seeking registration of human medicines in South Africa, SAHPRA has issued the guidance Clinical Guideline. The guideline provides detailed information on the clinical evaluation pathways available for human medicines and outlines the documentation, dat

Obtaining FDA approval for an Abbreviated New Drug Application (ANDA) is a major milestone in generic drug development. However, approval is only the beginning of a product's regulatory lifecycle. Generic drug manufacturers must continue to meet numerous postapproval obligations related to product quality, safety monitoring, labeling, manufacturing changes, reporting requirements, and regulatory compliance. To help the industry better understand these responsibilities, the FD

Two notable guidance documents released in 2026 address distinct but equally important aspects of healthcare regulation. The first, Drug and Device Manufacturer Communications With Payors, Formulary Committees, and Similar Entities, provides updated recommendations regarding the communication of healthcare economic and clinical information between manufacturers and healthcare decision-makers. The second, Intent to Exempt Certain Unclassified Medical Devices from Premarket Not

As genome editing technologies continue to advance, sponsors are increasingly developing innovative gene therapies targeting rare, serious, and life-threatening diseases. These programs often involve complex manufacturing processes, extensive nonclinical studies, sophisticated analytical testing, and lengthy clinical development timelines. To support more efficient development pathways, the FDA released the draft guidance, Leveraging Prior Knowledge in the Development of Huma

Artificial Intelligence (AI) is rapidly becoming an integral part of pharmaceutical development and regulatory operations. From drug discovery and clinical trials to manufacturing and pharmacovigilance, AI is transforming how medicines are developed, assessed, and monitored. The European Medicines Agency (EMA) published its 2025 AI Observatory Report to provide an overview of AI-related activities across the European Medicines Regulatory Network (EMRN). The report highlights