Regulatory Blog

Understanding MHRA Guidance on Medical Device Regulations, Regulatory Advice Meetings, and Regulatory Support Medical device manufacturers must navigate a wide range of regulatory requirements throughout the product lifecycle, from development and market access to post-market compliance and safety monitoring. To support stakeholders, the Medicines and Healthcare products Regulatory Agency (MHRA) has published several guidance documents covering medical device regulatory requi

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