Regulatory Blog

As FDA continues to modernize and digitize its medical device review infrastructure, the updated guidance eCopy Program for Medical Device Submissions  plays a central role in transitioning industry toward fully electronic submissions. The December 2025 revision, reflected in the attached document, expands the technical requirements, clarifies the interaction between the eCopy and eSTAR programs, and incorporates contemporary digital standards needed to support efficient, err

The FDA has released two important guidances addressing very different but equally critical domains of drug development: the " nonclinical safety evaluation of monospecific monoclonal antibodies " and the appropriate inclusion of " QTc Information in Human Prescription Drug and Biological Product Labeling " . While one guidance focuses on modernising preclinical toxicology expectations for biologics, the other ensures that cardiac electrophysiology risks are clearly and consi

Regulatory teams responsible for lifecycle management know that post-authorisation changes can quickly become complex, especially as products mature, manufacturing processes evolve, and emerging scientific data require frequent updates to quality and clinical documentation. To support consistent interpretation of EU Variation Regulation (EC) No 1234/2008, the European Medicines Agency (EMA) maintains an extensive Q&A document titled " Classification of Changes " —a practical

As regulatory systems evolve globally, Switzerland continues to harmonize and strengthen its medicinal product oversight through guidance that combines scientific rigor with procedural clarity. Two recent Swissmedic documents— the guidance on the Procedure with Prior Notification (PPN)   and the technical interpretation on environmental conditions for microbiological examination of non-sterile products — together illustrate how Swiss authorities aim to improve both regulato

As pharmaceutical modalities diversify—from traditional injectables to complex biologics, cell therapies, inhalation products, and medical gases—the integrity of container closure systems, delivery devices, manufacturing components, and raw materials has never been more critical. The FDA’s recent guidances reflect this evolving reality and aim to tighten quality expectations across the entire product lifecycle. Three key guidances are: Current Good Manufacturing Practice for

The U.S. FDA has released a draft guidance titled Cross-Center Master Files: Where to Submit , issued in November 2025 addressing a longstanding challenge in regulatory operations: determining which FDA center  should host a master file (MF) when the file must support multiple regulatory submissions across different FDA centers. This guidance aims to reduce industry confusion, avoid duplicate submissions, and streamline review processes when MFs are used across drugs, biolog

Paediatric drug development remains one of the most complex regulatory areas in the pharmaceutical landscape. Scientific uncertainty, evolving clinical insights, and gaps in early evidence often make it difficult for developers to design complete paediatric programmes at the initial stages of development. Recognising these challenges, the European Medicines Agency (EMA) has introduced a specialised mechanism known as the stepwise Paediatric Investigation Plan (sPIP) , formall

The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) updated the section 3.1: 'Implementation of new guidelines' through its official guidance titled Medicines: Apply for a Variation to your Marketing Authorisation   — a key reference for MA holders operating in the UK regulatory ecosystem. A variation is any change to the terms of an existing marketing authorisation, from simple administrative updates to changes that may affect quality, safety or efficacy. T

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...