Regulatory Blog

The South African Health Products Regulatory Authority (SAHPRA) has issued the Guideline on Post-Marketing Reporting of Adverse Drug Reactions (ADRs) to Human Medicine to guide Applicants and Holders of Certificates of Registration (HCRs) on the collection, management and reporting of safety information after registration. The guideline covers ADRs, Adverse Events Following Immunisation (AEFIs) and relevant safety information associated with human medicines, including biologi

The South African Health Products Regulatory Authority (SAHPRA) has issued the Guideline for Borderline Products to help determine the appropriate regulatory pathway for products where classification is unclear. The guideline addresses products that may fall within categories such as medicines, medical devices, cosmetics, disinfectants, foodstuffs or other consumer products. Classification is determined on a case-by-case basis. What Are Borderline Products? Borderline product

Swissmedic has published guidance on MAGHP Scientific Advice, which explains how applicants can obtain scientific advice during the development of medicinal products intended for the Marketing Authorisation for Global Health Products (MAGHP) procedure. The guidance covers regulatory, quality, preclinical, clinical and pharmacovigilance topics. Version 2.0 is valid from 13 August 2026. Purpose of MAGHP Scientific Advice MAGHP scientific advice provides applicants with an oppor

The European Medicines Agency (EMA) has issued guidance explaining how applicants and marketing authorisation holders can use SEPA Direct Debit Business-to-Business (B2B) to pay certain EMA fees. The guidance, dated 20 August 2026, covers mandate setup, payment collection, returned transactions, withdrawals and related requirements. Single Euro Payments Area framework (SEPA) Direct Debit B2B allows EMA to collect euro-denominated payments from business debtors using a signed

The UK parallel import licensing scheme allows a medicine authorised in a European Economic Area (EEA) Member State to be marketed in the UK, provided the imported product has no therapeutic difference from the UK cross-referenced product. The Medicines and Healthcare products Regulatory Agency (MHRA) guidance, “Medicines: apply for a parallel import licence,” explains the requirements for obtaining and maintaining a parallel import licence, including application procedures,

Therapeutic equivalence is an important consideration when evaluating multisource prescription drug products and their potential substitution. The U.S. Food and Drug Administration (FDA) uses therapeutic equivalence evaluations to determine whether certain approved drug products can be expected to have the same clinical effect and safety profile when used under the conditions specified in their labeling. The FDA has issued the Guidance for Industry: Evaluation of Therapeutic

Active immunotherapy products (ACTIMPs) are designed to treat existing diseases or conditions by inducing, stimulating, or modulating immune responses. Because their therapeutic effect depends on the interaction between the product and the immune system, demonstrating and maintaining product potency is an important part of development. The FDA has issued draft guidance on Potency Assessment of Active Immunotherapy Products, providing recommendations for developing and evaluat

Choosing the appropriate abbreviated approval pathway is an important consideration when developing a drug product for submission to the U.S. Food and Drug Administration (FDA). The pathway selected determines the type of information and data that can be used to support the application. The FDA has published the Guidance for Industry: Determining Whether to Submit an ANDA or a 505(b)(2) Application, which provides recommendations to help applicants determine whether a propose

Joint Clinical Assessments (JCA) provide a framework for assessing clinical evidence on the relative effects of health technologies on health outcomes at the EU level. For medicinal products within the scope of the Health Technology Assessment (HTA) Regulation, health technology developers need to provide information early in the process so that the JCA can be prepared and the relevant HTA procedures can begin. The European Commission has updated its guidance on the submissio

Improving the availability of medicines authorised in the European Union is a key priority for the European Medicines Regulatory Network. Supply chain disruptions can affect the continuity of medicine supply, making it important for Marketing Authorisation Holders (MAHs) to identify potential risks and establish measures to reduce the likelihood of shortages. The European Medicines Agency (EMA) has published guidance and a template for industry on implementing Shortage Preven

Clinical trials may need to be changed during their lifecycle because of developments in trial design, participant safety, medicines, scientific information, or trial administration. The Medicines and Healthcare products Regulatory Agency (MHRA) has published guidance, Clinical trials for medicines: modifying a clinical trial approval, explaining the different types of modifications that can be made to a clinical trial approval. The amended Clinical Trials Regulations took fu

Pharmacovigilance for medicines authorised in the UK covers activities including safety information reporting, signal detection, risk management, periodic safety reporting, post-authorisation safety studies, safety reviews, post-authorisation measures, and safety communications. The Medicines and Healthcare products Regulatory Agency (MHRA) has published Guidance on pharmacovigilance procedures to explain its approach to pharmacovigilance. The guidance was updated on 21 Augus

As pharmaceutical products become more complex, the container closure system (CCS) plays an increasingly important role in maintaining the safety, quality, stability, and performance of a drug product. Packaging is not simply a means of containing a medicine—it can directly influence product quality through interactions between the drug, packaging materials, manufacturing processes, and storage conditions. The U.S. Food and Drug Administration (FDA) has issued the draft guida

Formal meetings between the U.S. Food and Drug Administration (FDA) and sponsors or applicants can play an important role at critical points in drug and biological product development. These interactions provide an opportunity for sponsors to obtain regulatory advice, discuss development challenges, clarify specific issues, and support efficient planning of development and regulatory submissions. The FDA’s August 2026 guidance, Formal Meetings Between the FDA and Sponsors or

Access to accurate, up-to-date information about medicines is important for healthcare professionals, patients, and anyone seeking to understand how a medicine should be used safely. Product information provides details about the use of medicines, their properties, and the scientific basis for marketing authorisations. The Medicines and Healthcare products Regulatory Agency (MHRA) has updated its guidance, Find product information about medicines, to explain how users can acc

As pharmacovigilance systems continue to move toward standardized electronic reporting, efficient and reliable exchange of Individual Case Safety Reports (ICSRs) is essential for the timely management of adverse drug reaction information. Swissmedic has established an electronic exchange process based on the ICH E2B(R3) standard for the transmission of ICSRs between Marketing Authorisation Holders (MAHs) and Swissmedic. The Guidance for Industry on the Electronic Exchange of

Regulatory submissions for medicines and other human health products involve a range of application, assessment, maintenance, inspection, and administrative fees. The Health Products Regulatory Authority (HPRA) Guide to Fees for Human Products provides applicants with a structured framework for identifying the appropriate fee category and fee code to accompany applications submitted to the Authority. The guide covers fees associated with medicines, clinical trial authorisatio

Ensuring the availability and continuity of medicines across the European Union is an important priority for the European Medicines Regulatory Network. Supply chain disruptions can affect medicine availability, making it important for Marketing Authorisation Holders (MAHs) to identify potential risks and establish appropriate measures to reduce the likelihood of shortages. The European Medicines Agency (EMA) has published the Guidance for industry on implementing Shortage Pre

As clinical research becomes increasingly global, transparency in clinical trials is essential for strengthening public trust, supporting informed decision-making, and improving access to research information. Regulatory authorities continue to enhance public access to authorized clinical trial information while promoting greater openness throughout the clinical research lifecycle. Health Canada has introduced the Clinical Trials Search Portal, a centralized platform that ena

As generic transdermal and topical delivery systems (TDS) continue to evolve, demonstrating bioequivalence extends beyond pharmacokinetic performance. Product adhesion, skin irritation, and sensitization are critical attributes that influence drug delivery, patient safety, treatment adherence, and overall therapeutic performance. To support the development of high-quality generic transdermal and topical products, the U.S. Food and Drug Administration (FDA) has issued two comp