Regulatory Blog

South Africa continues to strengthen regulatory efficiency and regional collaboration through structured reliance pathways. The SAHPRA Medical Devices Reliance Guideline and the ZAZIBONA Centralised Procedure – SAHPRA’s Reliance Process  collectively demonstrate SAHPRA’s commitment to regulatory convergence within the SADC region. Guidance: Medical Devices Reliance Guideline – SAHPRA’s Structured Reliance Framework The Medical Devices Reliance Guideline outlines the principle

In February 2026, the U.S. Food and Drug Administration (FDA) issued a draft guidance for industry outlining considerations for using a Plausible Mechanism Framework  to develop individualized therapies that target specific genetic conditions with a known biological cause. The draft guidance, developed by the Center for Biologics Evaluation and Research (CBER) and the Center for Drug Evaluation and Research (CDER), describes how developers may generate substantial evidence o

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