Regulatory Blog

As pharmaceutical products become more complex, the container closure system (CCS) plays an increasingly important role in maintaining the safety, quality, stability, and performance of a drug product. Packaging is not simply a means of containing a medicine—it can directly influence product quality through interactions between the drug, packaging materials, manufacturing processes, and storage conditions. The U.S. Food and Drug Administration (FDA) has issued the draft guida

Formal meetings between the U.S. Food and Drug Administration (FDA) and sponsors or applicants can play an important role at critical points in drug and biological product development. These interactions provide an opportunity for sponsors to obtain regulatory advice, discuss development challenges, clarify specific issues, and support efficient planning of development and regulatory submissions. The FDA’s August 2026 guidance, Formal Meetings Between the FDA and Sponsors or

Access to accurate, up-to-date information about medicines is important for healthcare professionals, patients, and anyone seeking to understand how a medicine should be used safely. Product information provides details about the use of medicines, their properties, and the scientific basis for marketing authorisations. The Medicines and Healthcare products Regulatory Agency (MHRA) has updated its guidance, Find product information about medicines, to explain how users can acc

As pharmacovigilance systems continue to move toward standardized electronic reporting, efficient and reliable exchange of Individual Case Safety Reports (ICSRs) is essential for the timely management of adverse drug reaction information. Swissmedic has established an electronic exchange process based on the ICH E2B(R3) standard for the transmission of ICSRs between Marketing Authorisation Holders (MAHs) and Swissmedic. The Guidance for Industry on the Electronic Exchange of

Regulatory submissions for medicines and other human health products involve a range of application, assessment, maintenance, inspection, and administrative fees. The Health Products Regulatory Authority (HPRA) Guide to Fees for Human Products provides applicants with a structured framework for identifying the appropriate fee category and fee code to accompany applications submitted to the Authority. The guide covers fees associated with medicines, clinical trial authorisatio

Ensuring the availability and continuity of medicines across the European Union is an important priority for the European Medicines Regulatory Network. Supply chain disruptions can affect medicine availability, making it important for Marketing Authorisation Holders (MAHs) to identify potential risks and establish appropriate measures to reduce the likelihood of shortages. The European Medicines Agency (EMA) has published the Guidance for industry on implementing Shortage Pre

As clinical research becomes increasingly global, transparency in clinical trials is essential for strengthening public trust, supporting informed decision-making, and improving access to research information. Regulatory authorities continue to enhance public access to authorized clinical trial information while promoting greater openness throughout the clinical research lifecycle. Health Canada has introduced the Clinical Trials Search Portal, a centralized platform that ena

As generic transdermal and topical delivery systems (TDS) continue to evolve, demonstrating bioequivalence extends beyond pharmacokinetic performance. Product adhesion, skin irritation, and sensitization are critical attributes that influence drug delivery, patient safety, treatment adherence, and overall therapeutic performance. To support the development of high-quality generic transdermal and topical products, the U.S. Food and Drug Administration (FDA) has issued two comp

As biosimilar development continues to advance, regulatory expectations extend well beyond demonstrating analytical similarity and clinical performance. Product presentation—including the container closure system (CCS) and device constituent parts—has become an important aspect of ensuring product quality, usability, and patient safety throughout the product lifecycle. The U.S. Food and Drug Administration (FDA) has published the draft guidance Biosimilar and Interchangeable

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

Biosimilar medicines have become an integral part of modern healthcare by expanding patient access to biological therapies while maintaining high standards of quality, safety, and efficacy. As scientific knowledge, analytical technologies, and regulatory frameworks continue to evolve, regulatory guidance must also adapt to reflect these advancements. The Concept Paper on Revision of the Guideline on Similar Biological Medicinal Products sets out the European Medicines Agency'

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,

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