Regulatory Blog

Effective pharmacovigilance is essential for protecting patients and supporting the safe and effective use of medicinal products. The Guidelines on Good Pharmacovigilance Practices (GVP) provide a framework for pharmacovigilance activities in the European Union. The latest introductory cover note announces the publication of Revision 2 of Module III on Pharmacovigilance Inspections, reflecting recent changes to the applicable European pharmacovigilance legislation. Background

Accurate and structured medicinal product information is an important part of the regulatory and pharmacovigilance framework. Chapter 3.II: XEVPRM Detailed User Guidance provides detailed instructions for marketing authorisation holders (MAHs) on the electronic submission of information on medicinal products for human use to the European Medicines Agency through the XEVMPD. What is XEVPRM? XEVPRM stands for eXtended EudraVigilance Medicinal Product Report Message. It is the m

Advanced therapy medicinal products (ATMPs) are regulated medicinal products that include gene therapy medicinal products, somatic cell therapy medicinal products, and tissue-engineered products. The Advanced Therapy Medicinal Products: Regulation and Licensing in the UK guidance explains the regulatory and licensing arrangements for ATMPs in the UK, including product classification, regulatory advice, clinical trials, marketing authorisation, combination ATMPs, manufacturing

The Therapeutic Goods Administration (TGA) has updated its eCTD AU Module 1 and Regional Information v3.2 guidance. A 4 September 2026 update introduced minor editorial changes and added links to the TGA page Dossier requirements for non-prescription medicines and the new user guide Submitting data in electronic Common Technical Document (eCTD) format for a non-prescription medicine application. Dossier requirements for non-prescription medicines: Submitting data in eCTD form

Swissmedic has issued two guidance documents that provide important regulatory requirements for companies holding medicinal-product authorisations or establishment licences in Switzerland. One guidance covers renewal, discontinuation, and changes between the main authorisation and the export licence, while the other describes the process for Scientific GMDP Meetings with Swissmedic. Together, these guidances provide a structured framework for managing authorisation-related ac

The U.S. Food and Drug Administration (FDA) has issued the September 2026 draft guidance “Pharmacokinetics in Patients with Impaired Hepatic Function: Study Design, Data Analysis, and Impact on Dosing and Labeling”. The guidance provides recommendations for sponsors and applicants planning studies to evaluate how hepatic impairment affects the pharmacokinetics (PK) and, where appropriate, pharmacodynamics (PD) of drugs, including therapeutic biological products. It is a draft

Dental restorative materials and curing devices are important components of modern dentistry, and their safety and performance must be demonstrated before marketing. The U.S. Food and Drug Administration (FDA) has issued guidance documents describing recommendations for premarket notification (510(k)) submissions for dental composite resin devices and dental curing lights. The two guidance documents provide device-specific recommendations covering device description, predicat

Preparing a marketing authorisation application (MAA) requires a sufficiently complete and mature dossier before submission. The European Medicines Agency (EMA) has developed the EU Submission, Timelines and Review Talk (EUSTART) to help applicants, rapporteurs, national competent authority (NCA) assessment teams, and EMA identify important issues before an application is submitted. EUSTART supports preparation for the joint pre-submission meeting (PSM), with the aim of facil

Preparing a marketing authorisation application (MAA) requires early planning, clear communication, and a sufficiently mature dossier. To strengthen this process, the European Medicines Agency (EMA) has introduced a revised Guidance on the "Pre-Submission Interactions (PSI) model" as part of a voluntary pilot phase. The revised model aims to encourage earlier and more comprehensive dialogue between applicants, rapporteurs, and EMA. It focuses on improving submission readiness

As medicines move toward electronic formats, accurate and up-to-date product information is increasingly important. The European Medicines Agency (EMA) has issued guidance, "Electronic product information (ePI) submission during centralised procedures," explaining how applicants should submit, create, update, and maintain electronic product information (ePI) for centrally authorised medicinal products. The guidance provides practical instructions for managing ePI through the

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