Regulatory Blog

The Philippines FDA ("FDA Philippines") continues to enhance its regulatory frameworks to streamline processes and align with international best practices. Three recent draft guidelines open for public comments address critical areas impacting pharmaceutical products and medical devices for comment: Implementing Guidelines on the Post-Approval Changes of Registered Pharmaceutical Products for Human Use   (for human medicines) Guidelines on the Application for Variation of the

The South African Health Products Regulatory Authority (SAHPRA) plays a pivotal role in safeguarding public health by ensuring medicines are safe, effective, and properly labelled, and by maintaining robust pharmacovigilance through adverse drug reaction (ADR) reporting. In its continuous mission to strengthen medicine safety and promote patient wellbeing, the SAHPRA has issued two crucial documents: The Guideline for Labelling of Medicines Intended for Human Use , and The Gu

On 23rd October 2025, the South African Health Products Regulatory Authority (SAHPRA) continues to strengthen its regulatory framework to ensure that all medicines—whether registered, imported, or accessed under exceptional circumstances—meet the highest standards of safety, quality, and efficacy. Two of SAHPRA’s most recent guidance documents, namely the Guideline for Section 21 Access to Unregistered Medicines  and the Quality and Bioequivalence Guideline , play a pivotal r

The U.S. Food and Drug Administration (FDA) has released a new draft guidance   titled “ Scientific Considerations in Demonstrating Biosimilarity to a Reference Product: Updated Recommendations for Assessing the Need for Comparative Efficacy Studies ”  (October 2025). This document represents a major shift in the FDA’s scientific and regulatory approach to biosimilar product development, particularly regarding when comparative efficacy studies (CES) may or may not be required

The U.S. Food and Drug Administration (FDA) has recently released two significant draft guidance  documents that mark important steps forward in the modernization and harmonization of medical device regulations: Quality Management System (QMS) Information for Certain Premarket Submission Reviews Menstrual Products – Performance Testing and Labeling Recommendations Both are designed to increase transparency, strengthen product safety and quality, and align FDA’s approach with

In October 2025, the European Medicines Agency (EMA) released two landmark drafts for public consultation. These documents collectively signal the Agency’s evolving regulatory stance toward precision biologics such as bacteriophage therapy and innovative device–drug integration approaches to simplify clinical bridging for biologics delivered subcutaneously. 1. Quality Guidance for Phage Therapy Medicinal Products (PTMPs) The EMA draft guideline on phage therapy quality (Oct

The UK’s post-Brexit regulatory landscape for medical devices continues to evolve, placing renewed emphasis on safety, performance, and transparency. The Medicines and Healthcare products Regulatory Agency (MHRA) has issued clear guidance on both registering medical devices for market access and conducting clinical investigations, ensuring compliance with the UK Medical Devices Regulations 2002 (UK MDR 2002) and the Windsor Framework. This combined overview summarizes the lat

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has modernised its processes for evaluating, approving, and maintaining marketing authorisations (MAs) under a post-Brexit regulatory framework aligned with the Windsor Framework (effective January 2025). The MHRA’s guidance documents provide a clear roadmap for each of these phases: Variations to marketing authorisations (MAs)   – covers changes after a licence is granted. National Assessment Procedure for me

The U.S. Food and Drug Administration (FDA) continues to refine its regulatory guidance structure to ensure that patient experience, ethical access pathways, and robust data science converge effectively in modern drug development. Three cornerstone guidance documents released through 2024–2025 exemplify this integration — focusing on patient-focused drug development, expanded access to investigational drugs, and technical specifications for clinical trial data submissions. 1.

In a pivotal move to reduce avoidable regulatory delays, On October 23, 2025 the FDA has made public the internal filing checklists used by the Center for Drug Evaluation and Research (CDER) to determine whether a submitted application—such as a New Drug Application (NDA) or Biologics License Application (BLA)—meets the threshold of being “complete and reviewable.” By publishing these checklists, FDA aims to provide greater transparency , enabling sponsors to align better

When the ownership of a medicine changes—through a merger, acquisition, corporate restructure, or divestiture—the marketing authorisation...

The UK’s Medicines and Healthcare products Regulatory Agency ( MHRA ) has issued a coordinated update to its suite of clinical trial...