Regulatory Blog

Pharmacovigilance plays a critical role in protecting public health by enabling the timely identification, assessment, and management of medicine safety concerns. Accurate reporting of adverse drug reactions (ADRs) and Adverse Events Following Immunisation (AEFIs) allows regulatory authorities to continuously monitor the benefit-risk profile of authorised medicines and implement appropriate regulatory actions when necessary. To strengthen electronic pharmacovigilance reportin

Artificial Intelligence (AI) is rapidly transforming drug development by enabling more efficient data analysis, predictive modelling, and evidence-based decision-making. Early-phase clinical trials, particularly Phase 1 studies, represent one of the most challenging stages of drug development due to uncertainties surrounding dose selection, patient recruitment, safety monitoring, and progression decisions. Improving the efficiency of these trials has the potential to accelera

Maintaining the safety of the blood supply is a critical public health priority, particularly during outbreaks of emerging infectious diseases. Ebola disease, caused by viruses of the Orthoebolavirus genus, is associated with severe illness and can be transmitted through direct contact with infected body fluids. Although transfusion-transmitted Ebola disease has not been widely documented, the potential risk of transmission through blood and blood components requires appropri

Determining whether a product qualifies as a medical device is one of the most important regulatory decisions for manufacturers before placing a product on the Great Britain market. Many products fall into a "borderline" category because they may share characteristics with medicines, cosmetics, food supplements, biocides, personal protective equipment (PPE), or other regulated products. To provide greater regulatory clarity, the Medicines and Healthcare products Regulatory Ag

As regulatory systems become increasingly digital, standardized medicinal product data has become essential for improving regulatory efficiency and ensuring consistent information across the European medicines network. To support this transition, the European Medicines Agency (EMA) published the guidance Product Management Services (PMS) – Implementation of ISO Standards for the Identification of Medicinal Products (IDMP) in Europe – Chapter 3: Process for the Electronic Subm

Environmental sustainability is becoming an essential consideration in pharmaceutical manufacturing as production activities consume significant amounts of energy, water, raw materials, and solvents while generating emissions, effluents, and waste. These activities can affect ecosystems, contribute to climate change, and influence long-term public health. To help manufacturers integrate sustainable practices into pharmaceutical operations, the World Health Organization (WHO)

Manufacturers who intend to place medical devices on the market in Great Britain or Northern Ireland must comply with the registration requirements established by the Medicines and Healthcare products Regulatory Agency (MHRA). The Register Medical Devices to Place on the Market guidance explains which devices require registration, who is responsible for registration, applicable timelines, registration procedures, and the associated fees. It also outlines the differences in re

Clinical trials have traditionally been conducted using separate protocols to evaluate individual drugs for specific diseases or patient populations. While this approach has contributed significantly to medical innovation, it can be resource-intensive, time-consuming, and challenging when studying rare diseases or rapidly evolving therapeutic areas. To improve the efficiency of clinical development, the FDA issued the draft guidance "Master Protocols for Drug and Biological P

Demonstrating that a drug works as intended is one of the most important requirements for FDA approval. Before a new drug or biological product can reach patients, sponsors must provide strong scientific evidence showing that the product delivers meaningful clinical benefits. To clarify current expectations, the FDA issued the draft guidance "Demonstrating Substantial Evidence of Effectiveness for Human Drug and Biological Products." The guidance explains how sponsors can est

Immunogenicity is an important consideration in the development and regulatory evaluation of many biological products and therapeutic proteins. The formation of anti-drug antibodies (ADAs) can influence a drug's pharmacokinetic profile, potentially affecting drug exposure, efficacy, and safety. To support consistent regulatory assessment, the FDA issued the guidance "Submitting Clinical Trial Datasets to Evaluate the Impact of Immunogenicity on the Pharmacokinetics of a Drug.

Obtaining marketing authorisation for medicinal products in Ireland requires careful planning and early engagement with the Health Products Regulatory Authority (HPRA). To support efficient assessment and resource management, the HPRA has established guidance for companies seeking to submit new national marketing authorisation applications and for applicants requesting Ireland to act as the Reference Member State (RMS) in a Decentralised Procedure (DCP). The guidance document

As clinical research continues to evolve, decentralized clinical trials (DCTs) are becoming increasingly important. By incorporating technologies such as telemedicine, remote monitoring, electronic consent, and home healthcare services, decentralized trials can reduce participant burden and improve access to research opportunities. Recognizing this shift, Health Canada launched a consultation on its Draft Guidance for Decentralized Clinical Trials (DCTs). Feedback from indust

Bringing innovative medicines to patients requires more than scientific excellence. Pharmaceutical companies must navigate complex regulatory pathways, demonstrate product quality, ensure appropriate labeling, and comply with country-specific requirements before a medicinal product reaches the market. Swissmedic, Switzerland's national authority for therapeutic products, has established several regulatory mechanisms that facilitate patient access to innovative therapies while

Patent information plays a critical role in the regulatory framework for prescription drug approvals in the United States. Accurate submission of patent information helps ensure transparency regarding intellectual property protections associated with approved drug products and supports the operation of the FDA's Approved Drug Products with Therapeutic Equivalence Evaluations, commonly known as the Orange Book. To assist New Drug Application (NDA) applicants and NDA holders in

Clinical trials are conducted in accordance with approved protocols and regulatory requirements designed to protect participants and ensure the generation of reliable scientific data. However, changes may become necessary during the course of a study due to emerging safety information, operational considerations, scientific developments, or updates to study procedures. The MHRA guidance Clinical Trials for Medicines: Modifying a Clinical Trial Approval provides a framework fo

Understanding MHRA Guidance on Medical Device Regulations, Regulatory Advice Meetings, and Regulatory Support Medical device manufacturers must navigate a wide range of regulatory requirements throughout the product lifecycle, from development and market access to post-market compliance and safety monitoring. To support stakeholders, the Medicines and Healthcare products Regulatory Agency (MHRA) has published several guidance documents covering medical device regulatory requi

The registration of human medicines is a complex process that requires comprehensive scientific evidence demonstrating that a product is safe, effective, and manufactured to acceptable quality standards. To support applicants seeking registration of human medicines in South Africa, SAHPRA has issued the guidance Clinical Guideline. The guideline provides detailed information on the clinical evaluation pathways available for human medicines and outlines the documentation, dat

Obtaining FDA approval for an Abbreviated New Drug Application (ANDA) is a major milestone in generic drug development. However, approval is only the beginning of a product's regulatory lifecycle. Generic drug manufacturers must continue to meet numerous postapproval obligations related to product quality, safety monitoring, labeling, manufacturing changes, reporting requirements, and regulatory compliance. To help the industry better understand these responsibilities, the FD

Two notable guidance documents released in 2026 address distinct but equally important aspects of healthcare regulation. The first, Drug and Device Manufacturer Communications With Payors, Formulary Committees, and Similar Entities, provides updated recommendations regarding the communication of healthcare economic and clinical information between manufacturers and healthcare decision-makers. The second, Intent to Exempt Certain Unclassified Medical Devices from Premarket Not

As genome editing technologies continue to advance, sponsors are increasingly developing innovative gene therapies targeting rare, serious, and life-threatening diseases. These programs often involve complex manufacturing processes, extensive nonclinical studies, sophisticated analytical testing, and lengthy clinical development timelines. To support more efficient development pathways, the FDA released the draft guidance, Leveraging Prior Knowledge in the Development of Huma