Regulatory Blog

The European Union continues to strengthen its medical device regulatory framework through updated guidance on device classification, nomenclature (EMDN), and supply chain transparency. These updates aim to improve regulatory clarity, traceability, and patient safety, particularly under the MDR and IVDR frameworks. Key developments include the Update – MDCG 2021-24 Rev.1: Guidance on classification of medical devices (April 2026), alongside supporting guidance documents on EM

Introduction This guidance, "General Considerations for the Use of New Approach Methodologies in Drug Development" , published as a draft in March 2026 , provides a framework for using New Approach Methodologies (NAMs) in drug development. NAMs include approaches such as: In vitro models (simple and complex systems) In chemico methods In silico modelling The goal of this guidance is to improve human-relevant toxicology prediction and reduce reliance on animal testing. Backg

The development of biosimilar and interchangeable biological products is an important part of improving access to biological medicines. To support this process, the U.S. Food and Drug Administration (FDA) has issued guidance documents that clarify regulatory expectations under the Biologics Price Competition and Innovation Act (BPCI Act) . Two key FDA guidance documents provide detailed explanations through a question-and-answer format to help sponsors understand the regulat

As biosimilars and interchangeable biosimilars become an integral part of modern biologic therapy, promotional communications around these products require heightened regulatory care. To address recurring industry questions and reduce the risk of misleading claims, the FDA has issued the guidance Promotional Labeling and Advertising Considerations for Prescription Biological Reference Products, Biosimilar Products, and Interchangeable Biosimilar Products . Published in 12 Dec

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

The U.S. Food and Drug Administration (FDA) has finalized its guidance document on " Conducting Remote Regulatory Assessments (RRAs) ,"...

In June 2025, the U.S. Food and Drug Administration (FDA) released a new draft guidance titled “ Transfer of a Premarket Notification...

In South Africa, the licensing of medical device establishments is a vital step to ensure compliance with national health regulations and...

Yesterday (02 August, 2024), the Food and Drug Administration (FDA) announced that the final guidance on M12 drug interactions was...

Today (23 July,2024) the U.S. Food and Drug Administration (FDA) Center for Drug Evaluation and Research, and Center for Biologics...

The US Food and Drug Administration (FDA) issued a draft guidance for the industry yesterday titled “Addressing Misinformation About...

On 24 April 2026 (Wednesday) the Center for Drug Evaluation and Research and the Center for Biologics Evaluation and Research released a...

Earlier this week (14 February, 2024) the the U.S. Food and Drug Administration (FDA) released guidance "Charging for Investigational...

Last Friday (26 January 2024), the FDA Office of Regulatory Affairs announced the availability of a revised draft guidance for the...

On 21 November,2023 the USFDA issued updated guidance on "Translation of Good Laboratory Practice Study Reports: Questions and Answers"...

Recently this Friday (29-Sepetember, 2023), the European Commission's Clinical Trials Coordination and Advisory Group released an updated...

Earlier today (11th April 2023) USFDA released final guidance on"A Risk-Based Approach to Monitoring of Clinical Investigations Questions...

A draft guidance from the US Food and Drug Administration entitled "Electronic Systems, Electronic Records, and Electronic Signatures in...

Recently this week the South African Health Products Regulatory Authority (SAPHRA) released an updated "Guideline On Questions And...

In an announcement yesterday, USFDA released the below draft guidances for industry, developed with the assistance of ICH, the...