Regulatory Blog

The Operational Information Sharing Guidance   published by the Medicines and Healthcare products Regulatory Agency (MHRA) provides structured instructions for Marketing Authorisation (MA) applicants on how to consent to the sharing of operational information during the MA application process. This guidance supports improved planning across the UK health system to enable faster and more efficient patient access to newly authorised medicines. This applies to applications submi

For generic drug developers, receiving tentative approval (TA)  for an Abbreviated New Drug Application (ANDA) is a major milestone—but it is not the end of the regulatory journey. Moving from tentative approval to final FDA approval  requires careful planning, timely submissions, and technically compliant study data. To support applicants, the FDA has issued two complementary guidance documents: ANDA Submissions — Amendments and Requests for Final Approval to Tentatively App

Safety reporting is one of the most critical safeguards in clinical trials involving investigational drugs and medical devices. To ensure that safety information is collected, evaluated, and communicated effectively, the U.S. Food and Drug Administration (FDA) has issued two complementary guidance documents: Investigator Responsibilities — Safety Reporting for Investigational Drugs and Devices   (December 2025), and Sponsor Responsibilities — Safety Reporting Requirements and

Clinical trials are the foundation for understanding whether a medical product is safe and effective. However, for many years, clinical trial populations have not fully reflected the patients who ultimately use these products in real-world settings. To address this gap, the U.S. Food and Drug Administration (FDA) has issued two complementary guidance documents: Enhancing Participation in Clinical Trials — Eligibility Criteria, Enrollment Practices, and Trial Designs  (Decembe

Medicine shortages can have a direct and serious impact on patient care, healthcare systems, and public health across Europe. To strengthen coordination, improve visibility, and enable early action, the European Medicines Agency (EMA) has established the European Shortages Monitoring Platform (ESMP) . The ESMP is a central digital platform designed to support the prevention, identification, monitoring, and management of shortages of medicinal products across the EU and EEA.

Placing a medical device or in vitro diagnostic (IVD) on the UK market involves more than product design and manufacturing. Manufacturers must demonstrate regulatory compliance, engage effectively with regulators, and prepare for evolving post-market expectations. To support this, the UK government and the Medicines and Healthcare products Regulatory Agency (MHRA) have published a series of guidances and roadmaps that explain both current requirements and the future direction

Medical device regulation in the UK is designed to ensure that products placed on the market or manufactured for patient use are safe, effective, and appropriately controlled. While most manufacturers are familiar with the general requirements of the UK Medical Devices Regulations 2002 (UK MDR 2002), certain categories of devices and manufacturing scenarios are subject to additional, specific legal provisions. Two important MHRA guidance documents explain these areas in detai

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

Modern medicines development increasingly sits at the intersection of advanced chemistry and genomic science. On one hand, synthetic peptides represent a fast-growing therapeutic class that bridges small molecules and biologics. On the other, pharmacogenomics is reshaping how medicines are developed, evaluated, and ultimately used in patients. Recognising these parallel advances, the European Medicines Agency (EMA) has recently published two key scientific documents: the Guid

Post-authorisation changes are an inevitable part of medicinal product lifecycle management, and stability data play a critical role in demonstrating that such changes do not compromise product quality, safety, or efficacy. To harmonise expectations across the EU, the European Medicines Agency has issued Revision 3 of the Guideline on stability testing for applications for variations to a marketing authorisation . Adopted in December 2025 and effective from January 2026, this

Good Clinical Practice (GCP) serves as the foundational ethical and scientific standard that governs how clinical trials involving human participants are designed, conducted, recorded, and reported. In the United Kingdom, the Medicines and Healthcare products Regulatory Agency (MHRA) enforces these standards to protect participant safety and the integrity of clinical data. The official guidance on Good clinical practice for clinical trials  explains how sponsors, investigator

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

As the UK strengthens its regulatory framework for medical devices, the Medicines and Healthcare products Regulatory Agency (MHRA) outlines a clear system for sponsors intending to conduct clinical investigations. These investigations are essential for generating evidence on device performance and safety before market approval. The MHRA guidance, “ Clinical investigations for medical devices " : that provides a structured route that sponsors must follow before initiating any

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 European Medicines Agency (EMA) recently published new guidance titled “ Guidance for applicants: the ETF Scientific Advice that facilitates Clinical Trial Authorisations (SA-CTA ) ”, outlining how sponsors and applicants can benefit from harmonised scientific advice to accelerate clinical trial authorisation across the EU. 1. What the SA-CTA Scientific Advice Is The guidance explains that the SA-CTA scientific advice is a specialised type of EMA advice developed under th