Regulatory Blog

The UK medicines regulatory framework provides structured pathways for obtaining a licence to market a medicinal product. Two key guidance documents outline the National Assessment Procedure (NAP)  and the process to Apply for a licence to market a medicine in the UK . Together, these resources explain how applicants can submit, manage, and progress marketing authorisation applications within the UK regulatory system. Guidance: National Assessment Procedure (NAP) for Medicin

Reclassification of medicines is an important regulatory mechanism that allows changes to the legal supply status of a medicinal product in the United Kingdom. The UK guidance on reclassification explains how applicants can apply to change the classification of a medicine, outlines procedural pathways, and clarifies the regulatory expectations associated with such changes. Using the Reclassification Guidance The guidance is intended for marketing authorisation holders or app

The Food and Drug Administration (FDA) Philippines has issued a draft guideline for public comments outlining regulatory expectations for medical device establishments regarding record maintenance and post-market reporting. The draft provides structured guidance on importation and distribution records, product complaint handling, adverse event reporting, and field safety corrective actions (FSCAs). This guidance aims to strengthen traceability, post-market surveillance, and

In January 2026, the South African Health Products Regulatory Authority (SAHPRA) issued an important communication to stakeholders regarding Type II variation applications submitted under the Type II Pilot Programme. The update provides clarification on submission window compliance and temporary fee processing arrangements due to a system-related pricing limitation in the SAHPRA Engagement Portal. Background and Context SAHPRA acknowledged that certain applicants experienced

Australia’s Therapeutic Goods Administration (TGA) continues to strengthen regulatory clarity through updated guidance documents covering medical devices and over-the-counter (OTC) medicines. Guidance: Complying with Unique Device Identification requirements for medical devices – TGA The TGA’s guidance on Unique Device Identification (UDI) requirements outlines the regulatory framework for assigning and maintaining UDIs for medical devices supplied in Australia. The UDI sy

In February 2026, Swissmedic published updated guidance documents covering key regulatory and post-authorisation requirements for human medicinal products. These updates provide clarity on administrative changes, pharmacovigilance obligations, formal submission requirements, packaging standards, document protection, parallel import procedures, co-marketing authorisations, lifecycle management, and variations. Guidance: Change of Name or Domicile of the Authorisation Holder Th

The Guide for National Scientific and Regulatory Advice  issued by the Health Products Regulatory Authority (HPRA) outlines the framework for obtaining national scientific and regulatory advice to support the development of new or existing human medicinal products. The objective of this advice is to guide applicants in their development programmes; however, it does not replace or substitute the applicant’s legal and regulatory responsibilities in the development of their medi

Developing innovative medicines requires early, structured engagement with regulators. The UK’s Integrated Scientific Advice (ISA)  service provides coordinated, multidisciplinary guidance to help applicants generate robust evidence and navigate regulatory requirements efficiently. What is Integrated Scientific Advice (ISA)? Integrated Scientific Advice (ISA)  is a coordinated regulatory advice service that brings together expertise from across the UK regulatory landscape. I

In the transforming regulatory landscape for medical devices and in vitro diagnostics (IVDs), understanding the requirements for registration and market entry across the UK—especially in Great Britain (GB) and Northern Ireland (NI)—is essential for manufacturers, authorised representatives, and regulatory professionals. Post-Brexit regulatory divergence has resulted in distinct registration and conformity requirements in Great Britain versus Northern Ireland. Guidance: Regis

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 ever-evolving world of pharmaceutical and medical product regulation, correctly classifying your product is crucial. Some products fall into a “grey area” where they could be regulated as a medicinal product, a medical device, or another type of product such as a cosmetic, food supplement, or biocide. To help manufacturers and other stakeholders make this determination, the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) publishes detailed guidance on h

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