Regulatory Blog

Appropriate eligibility criteria are essential for protecting trial participants while ensuring that clinical trial populations are representative of patients who are expected to receive the investigational therapy in clinical practice. Overly restrictive eligibility criteria may unnecessarily exclude patients, delay trial enrollment, and limit the applicability of study results. The three FDA guidances—Cancer Clinical Trial Eligibility Criteria: Laboratory Values, Cancer Cli

Hemodialysis blood tubing sets are critical components of the extracorporeal blood circuit used during hemodialysis treatment. Manufacturers submitting a Premarket Notification (510(k)) for these devices should provide sufficient information to demonstrate that the device is safe, effective, and substantially equivalent to a legally marketed predicate device. The Hemodialysis Blood Tubing Sets – Premarket Notification (510(k)) Submissions outlines recommendations for device d

Clinical investigations play an important role in generating clinical evidence to demonstrate the safety, performance, and clinical benefit of medical devices before they are placed on the market. Manufacturers and sponsors must determine when a clinical investigation is required and follow the appropriate notification procedures before commencing a study in Great Britain. The guidance documents Medical Devices That Need a Clinical Investigation and Clinical Investigations fo

Clinical investigations are an essential part of demonstrating the safety and performance of medical devices before they are placed on the market. Organizations conducting investigations in Great Britain must ensure that studies are appropriately planned, approved, and supported with complete regulatory documentation. The guidance documents Clinical Investigations in Great Britain, Approving Clinical Investigations, and Compiling a Submission outline the regulatory framework,

Switzerland's regulatory framework for medicinal products and medical devices places strong emphasis on product quality, effective market oversight, and the safe conduct of clinical investigations. Recent Swissmedic information sheets provide important requirements for pharmaceutical companies, medical device manufacturers, sponsors, investigators, and other stakeholders operating in Switzerland. This blog provides a concise overview of three Swissmedic information sheets cov

Artificial Intelligence (AI) is increasingly being explored across evidence generation, analysis, and reporting, offering opportunities to improve the efficiency of processes supporting health technology assessment. However, when AI is used to prepare evidence for regulatory and assessment purposes, its potential benefits must be balanced against risks to completeness, methodological quality, scientific rigour, and reliability. To address these considerations, the Member Stat

Efficient regulatory submissions depend not only on preparing high-quality dossiers but also on using the correct submission systems and selecting the appropriate regulatory pathway. For companies seeking to submit medicines applications, clinical trial documentation, or safety reports in the UK, understanding the Medicines and Healthcare products Regulatory Agency (MHRA) submission infrastructure is essential. The MHRA provides guidance covering two important areas: Register

The UK clinical trials regulatory framework has undergone significant changes following amendments to the Medicines for Human Use (Clinical Trials) Regulations. These changes introduce updated requirements across clinical trial conduct, safety reporting, transparency, Good Clinical Practice (GCP), investigational medicinal products, and regulatory oversight. To support sponsors and investigators, the Medicines and Healthcare products Regulatory Agency (MHRA) has published upd

Ending a clinical trial is an important regulatory milestone that requires sponsors to meet specific notification, transparency, and reporting obligations. Properly closing a trial ensures that regulatory authorities are informed, trial results are made publicly available, and participants have access to understandable information about the research in which they participated. The Medicines and Healthcare products Regulatory Agency (MHRA) has published the guidance Clinical T

As drug development continues to evolve, regulatory expectations are becoming increasingly focused on scientific rigor, product quality, and reliable clinical evidence. Two recently published U.S. Food and Drug Administration (FDA) guidances address important areas of pharmaceutical development—clinical investigations for psychedelic drugs and bioequivalence evaluation of topical dermatologic corticosteroids. While these guidances focus on different therapeutic areas, both em

Before submitting an Over-the-Counter (OTC) Monograph Order Request (OMOR) or advancing the development of an OTC monograph drug, early engagement with the U.S. Food and Drug Administration (FDA) can help sponsors clarify regulatory expectations, discuss scientific evidence, and address potential development challenges. Structured interactions with the Agency allow sponsors to obtain timely feedback, improve development planning, and support efficient regulatory decision-maki

Before approving a New Drug Application (NDA) or Abbreviated New Drug Application (ANDA), the U.S. Food and Drug Administration (FDA) must ensure that the manufacturing facilities are capable of consistently producing medicines that meet Current Good Manufacturing Practice (CGMP) requirements. Preapproval Inspections (PAIs) are conducted to evaluate manufacturing readiness, verify the accuracy of Chemistry, Manufacturing and Controls (CMC) information, and confirm that facili

Innovation is transforming medicinal product development through the introduction of novel methodologies such as biomarkers, digital health technologies, artificial intelligence (AI), modelling and simulation, real-world data, patient registries, and advanced non-clinical testing methods. These approaches have the potential to improve evidence generation, streamline drug development, and support more informed regulatory decision-making. However, before they can be widely adop

Timely access to innovative medicines and biosimilars is an important objective for regulatory authorities worldwide. Collaborative assessment models enable regulators to share scientific expertise, reduce duplication of effort, and accelerate the availability of high-quality, safe, and effective medicines for patients. International work-sharing initiatives also promote regulatory convergence while maintaining robust scientific evaluation standards. The Medicines and Healthc

Access to accurate and up-to-date medicinal product information is essential for the safe prescribing, dispensing, and use of medicines. Healthcare professionals rely on authorised product information to make informed clinical decisions, while patients depend on clear instructions to use medicines safely and effectively. Providing easy access to approved regulatory information also promotes transparency throughout a medicine's lifecycle. The Medicines and Healthcare products

Pharmacovigilance plays a critical role in protecting public health by enabling the timely identification, assessment, and management of medicine safety concerns. Accurate reporting of adverse drug reactions (ADRs) and Adverse Events Following Immunisation (AEFIs) allows regulatory authorities to continuously monitor the benefit-risk profile of authorised medicines and implement appropriate regulatory actions when necessary. To strengthen electronic pharmacovigilance reportin

Marketing Authorisations (MAs) require updates throughout a medicine's lifecycle to reflect changes in manufacturing, quality, safety, efficacy, product information, or administrative details. To ensure that these changes are appropriately assessed and approved while maintaining product quality and patient safety, the Medicines and Healthcare products Regulatory Agency (MHRA) provides detailed guidance on applying for variations to UK Marketing Authorisations. The MHRA guidan

Medicines labelling and packaging are fundamental to the safe and effective use of medicines. Clear packaging enables patients, carers, pharmacists, and healthcare professionals to correctly identify medicines, understand essential safety information, and minimise the risk of medication errors. Poor label design, confusing layouts, or lookalike packaging can contribute to dispensing mistakes and inappropriate medicine use. To promote consistent and patient-focused packaging,

Medicines packaging, labelling, and Patient Information Leaflets (PILs) are essential components of medicine safety and regulatory compliance. They provide healthcare professionals and patients with critical information regarding the safe use, storage, administration, and identification of medicinal products. Throughout a medicine's lifecycle, these materials must remain accurate, up to date, and consistent with the approved product information to support patient safety and r

Maintaining the safety of the blood supply is a critical public health priority, particularly during outbreaks of emerging infectious diseases. Ebola disease, caused by viruses of the Orthoebolavirus genus, is associated with severe illness and can be transmitted through direct contact with infected body fluids. Although transfusion-transmitted Ebola disease has not been widely documented, the potential risk of transmission through blood and blood components requires appropri