Regulatory Blog

The South African Health Products Regulatory Authority (SAHPRA) has released the Guidelines to Good Manufacturing Practice for Medicines , effective 17 November 2025. This updated guideline aligns South Africa with the latest PIC/S GMP standards and strengthens regulatory expectations for manufacturers, importers, exporters, and distributors operating within the South African market. GMP is a system ensuring that medicinal products are consistently produced and controlled

The UK regulatory environment now offers two important pathways for bringing innovative medicinal therapies to patients: The Early Access to Medicines Scheme (EAMS) , which permits earlier availability of new medicines under conditions of unmet medical need; and The MHRA’s guidance “ Clinical trials for medicines: apply for authorisation in the UK ” , which provides the regulatory framework for initiating clinical trials of investigational medicinal products. These 2 guidance

The South African Health Products Regulatory Authority (SAHPRA) has issued an updated "Guideline for Destruction of Medicines and Scheduled Substances" outlining the safe and compliant destruction of medicines and scheduled substances across the country. This update aligns regulatory expectations with the Medicines and Related Substances Act (Act 101 of 1965)  and the National Environmental Management: Waste Act (2008) , reinforcing SAHPRA’s commitment to protecting public

With the 2025 amendments to the Medicines for Human Use (Clinical Trials) Regulations taking effect on 28 April 2026, the UK Medicines and Healthcare products Regulatory Agency (MHRA) has provided comprehensive guidance “ Clinical trials for medicines: modifying a clinical trial approval”  for sponsors and investigators which outlines how to manage changes to an approved clinical trial of a medicinal product. Types of Modification Modifications to a clinical trial approval f

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

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

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 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.

On 25 September 2025 , the U.S. Food and Drug Administration (FDA) highlighted four critical updated or reaffirmed guidances  spanning...

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...

On 22 September 2025 , the European Commission published new variations guidelines  in the Official Journal of the European Union. These...

On September 19, 2025, the U.S. Food and Drug Administration (FDA) released its revised draft guidance, “ Safety Labeling...

The U.S. Food and Drug Administration (FDA) released three important draft guidances  on September 11, 2025, providing updated...

The U.S. Food and Drug Administration (FDA) has issued a final guidance on 11th September 2025 titled “ Alternative Tools: Assessing Drug...

In 08 September 2025, the U.S. Food and Drug Administration (FDA) issued two final guidances addressing critical aspects of biosimilar...

On 1 September 2025 , Swissmedic published a set of updated guidance documents that refine requirements for medicinal product...

The Medicines and Healthcare products Regulatory Agency (MHRA) plays a pivotal role in regulating medicines, medical devices, and related...