NOTICIAS

EMA Updates Guidance on National Pharmacovigilance Contact Person Requirements ✅ Clarifications of national expectations ✅ Corrections to legal references ✅ Alignment with local legislation ✅ A few regulatory changes in specific countries...

The FDA just issued for comment the ICH E20 draft guideline on adaptive designs in confirmatory clinical trials. (Until finalized, existing regional guidances still govern.) Here are a few of our key takeaways: ▪️ An "adaptive design" is a prospectively...

The European Court of Auditors' Special Report on Critical Shortages of Medicines is worth reading. To ensure we tackle the underlying causes of shortages, ECA put forward key recommendations. Here are a few of them: ✅ Manufacturers have to report shortages on...

The European Directorate for the Quality of Medicines & Healthcare (EDQM) has published “Guidelines on key considerations in issuing recommendations on the classification of active substances as regards their supply (prescription and non-prescription status)”,...

This eBook is a collection of questions and answers designed to support manufacturers in navigating their performance evaluation obligations under the In Vitro Diagnostic Medical Devices Regulation (IVDR) (EU) 2017/746. The content reflects the collective expertise of...

É com grande satisfação que anunciamos que a Formiventos é, pelo quarto ano consecutivo, uma empresa certificada TOP 5% MELHORES PME PORTUGAL, edição de 2025, certificação atribuída pela SCORING, em termos de desempenho e solidez financeira.  A SCORING, LDA (NIF 515...

This document, hereafter called the Manual, records the agreements reached by the Member State members of the Borderline and Classification Working Group (BCWG) following the exchanges under the Helsinki Procedure under Regulation (EU) 2017/745 on medical devices (the...

The International Council on Harmonisation (ICH) announced  the adoption of its M14 guideline, which aims to harmonize the planning, design, and reporting of pharmacoepidemiologic studies that use real-world data (RWD) to evaluate the safety of marketed drugs and...

What FDA Auditors Are Finding Lately: 8 Trends Across GMP and GCP Audits (Q2 2025) What’s in this analysis This trends write-up uses only the audit reports in this project set from late spring–summer 2025. The set includes audit engagements across distinct contexts:...

This document aims at explaining and clarifying questions related to Trend reporting as outlined in  Article 88 of the Regulation (EU) 2017/745 on medical devices (MDR) and Article 83 of Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR) (“the...

FDA is issuing this guidance to provide recommendations on computer software assurance for computers and automated data processing systems used as part of medical device production or the quality system. This guidance describes a risk-based approach to establish...

The Data Act (Regulation (EU) 2023/2584) establishes harmonised, horizontal rules to ensure fairness in the allocation of value generated from data across market actors, while safeguarding the interests of those who invest in data-generation technologies. For an...

The FDA has released updated guidance on biosimilar development, emphasizing comparative analytics and quality considerations. This guidance provides a clear roadmap for faster, science-driven approvals and helps ensure safe, effective, and high-quality therapies...

The Food and Drug Administration is announcing the availability of a final guidance for industry entitled “E6(R3) Good Clinical Practice.”  This revision incorporates flexible, risk-based approaches and embraces innovations in trial design, conduct, and technology....

Entrou em vigor, a 1 de janeiro de 2025, a revisão do Regulamento Europeu relativo a alterações aos termos das autorizações de introdução no mercado (AIM) de medicamentos — Regulamento Delegado (UE) 2024/1701, de 11 de março de 2024, que altera o Regulamento (CE) n.º...

This document provides answers to questions frequently asked by stakeholders related to Regulation (EU) 2021/2282 of the European Parliament and of the Council of 15 December 2021 on health technology assessment and amending Directive 2011/24/EU (‘the HTA...

As indicated in the IMDRF Terms of Reference (ToR), IMDRF activities and initiatives may fall into several categories, one of which being technical documents created to address technical matters relating to the regulation of medical devices. The process for developing...

Posted on 28.08.2025 Digitalisation is reshaping how healthcare is delivered, and medical technologies are at the centre of this shift. Digital medical technologies, including connected devices, diagnostic software, and AI-enabled solutions, are key in supporting...

The FDA recently published a final guidance on marketing submission recommendations for a PCCP for AI-enabled device software functions. It sets up a framework for how manufacturers should structure and submit PCCPs as part of their premarket submissions.

Guidance Clinical investigations for medical devices How to notify the MHRA of your intention to carry out a clinical investigation for medical devices. From: Medicines and Healthcare products Regulatory Agency Published 18 December 2014 Last updated 27 August...

The guideline applies to the risk assessment and control of leachables in new drug products,  including cell and gene therapy products. Drug-device combination products that require  marketing authorizations and meet the definition of pharmaceutical or biological...

The guideline is intended to address the specific concerns related to the cultivation, harvesting, collection, and primary processing of herbal substances that are used for the preparation of herbal medicinal products. It addresses specific issues associated with...

The European Commission’s Directorate-General for Health and Food Safety (DG SANTE) - through the European Health and Digital Executive Agency (HaDEA) - has commissioned a “Study supporting the monitoring of availability of medical devices on the EU market”. The study...

FDA is announcing the availability of a final guidance for industry entitled “Conducting Remote Regulatory Assessments--Questions and Answers.” The final guidance makes further revisions to and replaces the revised draft guidance entitled “Conducting Remote Regulatory...

The EMA eCTD team and the EU eCTD v4.0 Subject Matter Experts are pleased to announce that a draft EU eCTD v4.0 validation criteria is now available here. The list is a combination of rules existing in eCTD 3.2.2 (adapted to the new standard, where necessary), and new...

At the end of July, The FDA’s Office of Pharmaceutical Quality released a 21-page white paper positioning mature quality practice as both a financial and public-health imperative. Structured in two parts, the analysis first maps a four-stage cost curve (from “minimal”...

The new    COMMISSION IMPLEMENTING REGULATION (EU) 2025/1466 of 22 July 2025,, amending Implementing Regulation (EU) No 520/2012 on the performance of pharmacovigilance activities provided for in Regulation (EC) No 726/2004 of the European Parliament and of the...

The EU medical device regulatory framework (Medical Devices Regulation 2017/745 and In Vitro Diagnostic Medical Devices Regulation 2017/746) is at a pivotal moment. Fragmentation, inefficiencies, and inconsistent application of rules are undermining the goals of...

    8 July 2025 EMA/144509/2025 European Medicines Agency   This report provides an overview of the response of the European Medicines Regulatory Network (EMRN) to the presence of nitrosamine impurities in human medicines. Following the discovery in...

As outcome of an EudraVigilance audit performed by the European Data Protection Supervisor (EDPS) in the context of pseudonymisation procedures and personal data masking, the EDPS recommended to the Agency to adopt, together with the joint controllers (European...

The European Medicines Agency (EMA) publishes information on human medicinal products at various stages of their life cycle, from the early developmental stages through to EMA’s evaluation of authorisation applications, post-authorisation changes, safety reviews and...

In June 2025, the FDA released a white paper emphasizing the need for stronger cybersecurity in medical product manufacturing, specifically focusing on Operational Technology (OT). The paper, titled "Securing Technology and Equipment (Operational Technology) Used for...

  The European Medicines Agency (EMA) has published Version 6.0 of the Sponsor Handbook: CTIS User Guidance on the Sponsor’s Workspace (EMA/186412/2021). This comprehensive update supports sponsors in navigating the Clinical Trial Information System (CTIS),...

We’re proud to share the latest progress in integrating Real-World Evidence (RWE) into regulatory decision-making; 3rd report on the experience gained with regulator-led studies from February 2024 to February 2025, aligned with the EMRN Strategy to 2028 and in...

EU Commission Decision Update! (Expert Panels – Medical Devices) The European Commission has published Implementing Decision (EU) 2025/1324, amending Decision (EU) 2019/1396, introducing changes to the governance and scope of expert panels under the Medical Devices...

.. The European Commission has launched EUDAMED v2.15.0

EUROPE’S LIFE SCIENCES OPPORTUNITY: A STRATEGIC VISION FOR GLOBAL LEADERSHIP COMMUNICATION FROM THE COMMISSION TO THE EUROPEAN PARLIAMENT, THE COUNCIL, THE EUROPEAN ECONOMIC AND SOCIAL COMMITTEE AND THE COMMITTEE OF THE REGIONS Choose Europe for life sciences A...

Code of Conduct for Notified Bodies under Regulations (EU) 2017/745 and (EU) 2017/746 "Improving implementation of the European CE certification of medical devices through the harmonisation of Notified Bodies" Version: 5.1 Date: June 25th 2025 This updated Code of...

Just published: 3rd progress report on the use of real-world evidence (RWE) in medicines regulation (February 2024 - February 2025) Key highlights: 📌 59 RWE studies conducted - nearly 50% more than during the previous reporting period; 📌 DARWIN EU...

On the basis of the New Legislative Framework, as clarified in the Commission notice ‘The “Blue Guide” on the implementation of EU product rules 2022’, the general rule is that more than one legal act of Union harmonisation legislation, such as the MDR and the IVDR...

This document provides FDA’s recommendations to industry regarding cybersecurity device design, labeling, and the documentation that FDA recommends be included in premarket submissions for devices with cybersecurity risk. These recommendations are intended to promote...

This scientific opinion reflects the views of independent experts (MDR Article 106) on the clinical evaluation assessment report (CEAR) of the notified body. The advice is provided in the context of the clinical evaluation consultation procedure (CECP), which is an...

Commission Implementing Regulation (EU) 2021/2226 (2) limits its application to certain medical devices and their accessories. The results of a survey on replacing paper-based instructions for use by electronic instructions for use the Commission carried out from 1...

This document provides a first set of answers, that will be continuously developed and updated, to the most frequently asked questions related to the joint application of the AIA and the MDR or IVDR4 for manufacturers. This Frequently Asked Questions (FAQ) document is...

This document is intended for sponsors of performance studies of in vitro diagnostic medical devices (IVDs) conducted within the scope of the Regulation (EU) 2017/746 (IVDR). It also contains information of relevance to manufacturers providing IVDs for use in...

This document, which primarily targets Medical Device Software (MDSW) manufacturers, provides guidance on: • the criteria for the qualification of software falling within the scope of the Medical Device Regulations , including Medical Device Artificial Intelligence...

EMA’s annual report 2024 published on June 10th, gives insights into the Agency’s strategic priorities and contributions to public and animal health in the European Union (EU). The digital report outlines the most important highlights regarding the evaluation and...

Software Applications (Apps) are significantly changing our way of living, helping in various aspects of our daily lives, including healthcare. Medical device software (MDSW) Apps cover an extensive variety of uses such as those intended to drive insulin pumps, detect...

The European Medical Device Nomenclature (EMDN) is the nomenclature of use by manufacturers when registering their medical devices in the EUDAMED database. Founded on pre-established criteria and requirements and based on orientations provided by the Medical Device...

The new European biotech act, announced in Ursula von der Leyen's political guidelines for 2025, was not included in the Commission work programme published on 11 February, but has recently been announced for early 2026.

This publication seeks to assist organizations with incorporating cybersecurity incident response recommendations and considerations throughout their cybersecurity risk management activities as described by the NIST Cybersecurity Framework (CSF) 2.0. Doing so can help...