Regulatory Blog

Post-market vigilance is a critical component of medical device regulation. While pre-market assessment ensures that devices meet essential safety and performance requirements before approval, real-world use can reveal risks that were not apparent during clinical evaluation. Recognising this, the Therapeutic Goods Administration  (TGA) has introduced structured requirements for healthcare facilities to report medical device adverse events. The guidance titled “Reporting medic

The integration of modeling and simulation into drug development has evolved from a supportive analytical tool to a central pillar of regulatory decision-making. Recognising this shift, the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use has formally adopted ICH M15: Guideline on General Principles for Model-Informed Drug Development (MIDD)  at Step 5 . The guideline was: Endorsed under Step 2 on 6 November 2024 Adopted by r

Medical gases such as oxygen, nitrous oxide, and medical air are essential components of modern healthcare. Although they are widely used and often considered routine clinical supplies, these gases are regulated as drugs under the Federal Food, Drug, and Cosmetic Act (FD&C Act). Recognising the unique nature of these products, Congress created a dedicated certification pathway for Designated Medical Gases (DMGs)  under sections 575 and 576 of the FD&C Act. On 11 February 2026

In February 2026, FDA issued an updated guidance titled Computer Software Assurance for Production and Quality Management System Software , superseding the September 2025 version. In parallel, FDA released an updated Cybersecurity in Medical Devices: Quality Management System Considerations and Content of Premarket Submissions  guidance, reflecting the growing cyber risk associated with digital and connected medical technologies. Together, these guidances signal a shift awa

Artificial Intelligence (AI) is no longer a future concept in pharmaceutical research—it is already influencing how drugs and biological products are discovered, developed, manufactured, and monitored throughout their lifecycle. However, when AI outputs are used to support regulatory decisions , questions of trust, transparency, and accountability become critical. Recognising this, global regulators have begun defining expectations for the responsible use of AI in drug devel

As innovation in healthcare rapidly expands across digital health, medical devices, and advanced clinical trial designs, regulatory expectations must evolve in parallel. Recognising this shift, the US Food and Drug Administration (FDA) released and updated several key guidance documents in January 2026 , offering clarity on how emerging technologies and novel scientific approaches should be developed, evaluated, and regulated. These guidances collectively address clinical dec

The U.S. Food and Drug Administration announced the availability of a draft guidance for industry titled " M4Q(R2) The Common Technical Document for the Registration of Pharmaceuticals for Human Use: Quality. " Prepared under the International Council for Harmonisation (ICH), this draft establishes a globally harmonized framework for organizing and presenting quality data in registration applications for human medicines. It updates the CTD's quality section to enhance registr

In the United Kingdom, the regulatory landscape operates under a well-defined set of guidance documents established and maintained by the UK Government and the Medicines and Healthcare products Regulatory Agency (MHRA). These documents help sponsors, regulatory affairs teams, and clinical operations professionals comply with UK law while ensuring patient safety and data integrity. In 2026, several key guidances outline the authorisation process, trial notifications, reporting

In 2026, several key guidances published on GOV.UK clarify the rules manufacturers, sponsors, and regulators must follow for clinical investigations, market placement, conformity assessment, and exemptions. This blog covers four major guidances released and maintained by the Medicines and Healthcare products Regulatory Agency (MHRA) and the UK Government. Collectively, they form an essential framework for anyone involved in medical device development, clinical evaluation, reg

The 10th edition of the Indian Pharmacopoeia 2026  was launched by the Union Health Minister in the first week of January 2026 with 121 new monographs, Indian Pharmacopoeia 2026 ha now 3,340 monographs. The Indian Pharmacopoeia is now recognized in 19 countries. Guidance Document on Compounding of Offences under the Drugs and Cosmetics (Compounding of Offences) Rules, 2025   This guidance has been issued by the Central Drugs Standard Control Organization (CDSCO) to support r

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

Developing a new drug is a long, expensive, and complex process. To make drug development more efficient and scientifically robust, the U.S. Food and Drug Administration (FDA) encourages the use of Drug Development Tools (DDTs) . These tools help sponsors generate better data, make informed decisions, and reduce uncertainty during drug development. To support this, FDA has established formal Drug Development Tool Qualification Programs, described on the FDA website Drug Deve

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

Radiopharmaceuticals present unique quality challenges due to their radioactive nature, short shelf lives, and frequent need for on-site or near-patient preparation. To reflect scientific and technological advances since the original 2007 guideline, the European Medicines Agency has released the draft Guideline on quality of radiopharmaceuticals – Revision 2  for public consultation. Adopted by CHMP in December 2025, this revision provides updated expectations for quality doc