Regulatory Blog

Clinical trials play a critical role in evaluating the safety and effectiveness of medicines before they are made available to patients. In the United Kingdom, the Medicines and Healthcare products Regulatory Agency (MHRA) provides guidance to help sponsors and researchers comply with regulatory requirements for clinical trials involving medicinal products. This article provides a consolidated overview of MHRA guidance covering several key areas of clinical trial regulation,

The U.S. Food and Drug Administration (FDA) has issued guidance documents to help pharmaceutical manufacturers understand regulatory expectations related to market exclusivity for drug products and responses to inspection findings following CGMP inspections . These guidances support transparency in regulatory processes and help industry ensure compliance with quality and development requirements. Guidance: New Clinical Investigation Exclusivity (3-Year Exclusivity) for Drug

This blog summarizes two important regulatory guidances from the U.S. Food and Drug Administration (FDA) that support pharmacovigilance and real-world evidence generation: M14: General Principles for Planning, Designing, Analyzing, and Reporting Non-Interventional Studies E2D(R1): Post-approval Safety Data – Definitions and Standards for Management and Reporting of Individual Case Safety Reports Together, these guidances provide a framework for how pharmaceutical companies ge

The U.S. Food and Drug Administration (FDA) has issued a final rule titled “ Revising the National Drug Code Format and Drug Label Barcode Requirements .” This rule introduces a uniform 12-digit National Drug Code (NDC) format to standardize how drugs marketed in the United States are identified. The National Drug Code is an FDA standard used to uniquely identify drug products marketed in the U.S. Currently, the NDC assigned by FDA is a 10-digit number , and it may appear i

The Medicines and Healthcare products Regulatory Agency (MHRA) provides an online portal that enables organisations and individuals to submit regulatory forms and manage applications electronically. The MHRA Portal is designed to streamline regulatory submissions, improve efficiency, and provide a centralised system for interacting with the agency. This guidance explains how users can register for the MHRA Portal, outlines the registration process, and describes key considera

The Early Access to Medicines Scheme (EAMS) is a regulatory initiative in the United Kingdom designed to provide patients with life-threatening or seriously debilitating conditions earlier access to promising medicines before full marketing authorisation is granted. The scheme is administered by the Medicines and Healthcare products Regulatory Agency (MHRA) and aims to accelerate patient access to innovative treatments where there is a clear unmet medical need. The main obj

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

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

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

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

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