NOTICIAS

This report presents 73 examples of market authorizations from fiscal years (FY) 2020-2025 building on the foundational work presented in the 2021 publication “Examples of Real-World Evidence (RWE) Used in Medical Device Regulatory Decisions,” which documented 90...

Update: April 10, 2026 The FDA has updated its Electronic Medical Device Reporting (eMDR) framework, confirming the transition to the ESG NextGen Unified Submission Portal As of April 14, 2025, the ESG NextGen portal replaces the legacy WebTrader interface, providing...

European Commission and HMA published the materials from the ACT EU webinar (8 April) presenting the new draft guidance on the conduct of clinical trials during public health emergencies (PHEs) — Now open for public consultation until 30 April 2026.

The European Medicines Agency (EMA) has released a draft roadmap for the implementation of electronic Product Information (ePI). This marks a major shift from traditional Word/PDF documents to a fully digitized, structured format designed to improve accessibility and...

This document is based on questions frequently raised to EMA by sponsors during CTIS events such as Walk-in Clinics, Bitesize Talks, and through the EMA CTIS Service Desk. It serves as complementary document to the Sponsor Handbook, which is the main operational...

The EMA Clinical Trials Information System (CTIS) Sponsor Handbook provides clinical trial (CT) sponsors representing pharmaceutical industry, SME (small and medium-sized enterprises), academia, research organisations and other clinical trial sponsor organisations...

Q&A on practical aspects related to the implementation of the Article 10a obligation in case of interruption or discontinuation of supply of certain devices as introduced by Regulation (EU) 2024/1860 amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards...

This document is intended for manufacturers that are developing AI-enabled medical devices to  identify considerations as they make critical technical and governance choices. It is intended to  provide considerations specific to where AI-enabled medical devices may...

The latest publication of harmonised standards under the Medical Devices Regulation (MDR) – April 2026 is now available. These updates are essential for manufacturers and stakeholders to demonstrate compliance with the MDR, providing presumption of conformity with the...

In March 2026, the now final "Guideline on the chemistry of active substances" was published on the EMA website. As reported in the news "EMA/CHMP: New Guideline Draft on Active Substances published for Comment", the draft guideline was open for public consultation...

EMA released the "Data Quality Framework for EU medicines regulation: application to Real-World Data", establishing the principles and definitions under the scope of datasets used in medicine regulatory use cases.   This document describes the Real-World Data...

Decorreu nos dias 24 e 25 de março  a formação  BOAS PRÁTICAS de FARMACOVIGILÂNCIA bajo o lema " Análise do conjunto de regulamentações, documentos e informações que permitem ao titular de AIM avaliar a sua área de farmacovigilância face as exigências regulamentares....

The European Medicines Agency (EMA) has published a new version of the '3-year work plan for the Inspectors Working Group' covering the period from January 2026 to December 2028. This workplan sets out the routine activities of the GMDP IWG that contribute to the...

“ Formação muito clara e prática acerca de vários temas da gestão da qualidade . “ GENERIS   Nos dias 23 e 24 de março, decorreu em Lisboa a formação  QUALITY MANAGEMENT SYSTEMS, bajo o lema " Uma visão completa e essencial na aprendizagem dos conceitos e...

Well established technologies (WET) are relatively simple devices, having common and stable designs with little evolution, well-known safety and clinical performance characteristics and a long history on the market. Criteria for identifying WET have been set in...

The document contains a comprehensive set of amendments aimed at simplifying the EU AI Act’s implementation, improving proportionality for SMEs/SMCs, reinforcing AI Office powers, prohibiting harmful AI misuse (like sexual deepfakes), clarifying conformity...

No passado 20 de março, decorreu em Lisboa  uma nova edição da formação exlusiva da Formiventos sobre " Registo Investigação e Tratamento de RECLAMAÇÕES de QUALIDADE e de DISTRIBUIÇÃO", conduzida por Sónia Rei, Associate Director Operations, na Hikma A  iniciativa...

This edition cancels and replaces the first edition (ISO 20417:2021), which has been technically revised. ISO 20417:2026 sets out requirements for the information that manufacturers must supply with medical devices and their accessories, including labelling,...

Well established technologies (WET) are relatively simple devices, having common and stable designs with little evolution, well-known safety and clinical performance characteristics and a long history on the market. Criteria for identifying WET have been set in...

Report on the experience with the new PRIME features following the 5-year review of the scheme to support the development of medicines targeting unmet needs   This report presents the findings from a two-year pilot (April 2023–March 2025) to assess the...

The U.S. Food and Drug Administration today issued a draft guidance intended to help drug developers validate new approach methodologies (NAMs) to be used instead of animal testing in drug development, and to bring safe, effective drugs to market sooner based on...

The Council and the European Parliament have reached an agreement on the ‘pharma package’, a new set of rules that will increase patients' access to medicine and make the EU’s pharmaceutical sector fairer and more competitive. The package represents a far-reaching...

The Committee of Permanent Representatives of the EU Member States (COREPER I) has approved the trilogue outcome reached in December 2025. The final texts have now been officially published: The new DIRECTIVE OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on the Union...

The European Union continues to take important steps in shaping the future of responsible AI governance. The European Commission has launched a new initiative under the Artificial Intelligence Act to define the detailed arrangements for evaluations and proceedings...

Decorreu na semana passada mais uma edição da formação exclusiva de Formiventos :GDP Nível 2 : BOAS PRÁTICAS DE DISTRIBUIÇÃO Nível Avançado Uma oportunidade perfeita para consolidar e completar a sua formação anterior em Boas Práticas de Distribuição, que  permite...

On 16 December 2025, the European Commission put forward a proposal for a regulation to simplify the rules governing medical devices in the EU. The proposal forms part of a broader package of measures aimed at improving citizens' health and strengthening the...

On the Proposal for a Regulation on establishing a framework of measures for strengthening Union’s biotechnology and biomanufacturing sectors particularly in the area of health (European Biotech Act) Adopted on 10 March 2026

The U.S. Food and Drug Administration has issued a guidance document titled “Q&As on Biosimilar Development and the BPCI Act.” This guidance provides FDA’s current thinking on regulatory and scientific considerations for developing biosimilar products under the...

The joint HMA/EMA Network Data Steering Group (NDSG) is the strategic advisory group established to maximise data interoperability and exchange, to improve access to data and evidence generation, and to leverage Artificial Intelligence (AI) for the benefit of public...

Just published a draft guidance detailing how clinical trials should be designed and conducted when public health emergencies arise. The document is aimed at sponsors and all parties involved in clinical research across the EU. The document provides practical...

publicado no site infarmed  Foi  publicada em Diário da República a Lei n.º 9/2026, de 6 de março, diploma que assegura a execução, na ordem jurídica nacional, do Regulamento (UE) n.º 536/2014 relativo aos ensaios clínicos, e procede à terceira alteração à Lei da...

This guidance provides FDA’s current thinking on the scope and application of 3-year exclusivity under section 505(c)(3)(E)(iii) and 505(j)(5)(F)(iii) of the FD&C Act for drug products approved with new clinical investigations (other than bioavailability studies)...

“Formação bastante esclarecedora, em que a informação foi apresentada de forma clara e bem resumida servindo de bom ponto de partida para aprofundar conhecimentos no papel da IA na indústria farmacêutica. Foram também apresentados exemplos práticos o que permitiu...

A Formiventos apresentou no passado dia 27 uma nova edição da formação : GESTÃO da DISPONIBILIDADE do MEDICAMENTO ✅Foi uma formação com uma forte componente prática, com o objetivo de alargar a experiência e o conhecimento relativo aos pontos críticos das...

The information in this document applies to all medical devices, including IVD medical devices. Unless otherwise specified, the principles discussed can be applied to any phase of the product lifecycle (e.g., technical documentation2 review, evaluation of quality...

MDRF International Medical Device Regulators Forum. Considerations for the selection of IMDRF Adverse Event Terminology A Guide for Industry Partners and Healthcare Providers. 25 February 2026 Scope: This document is intended to provide guidance on the correct...

A concept paper on the revision of Annex 15 has been published on the EMA's website. One of the main objectives of the revision is to make the application of Annex 15 mandatory for active substances (APIs). Until now, its application has been optional for active...

  The Food and Drug Administration (FDA, Agency, or we) is announcing the availability of a draft guidance for industry entitled “E22 General Considerations for Patient Preference Studies.” The draft guidance was prepared under the auspices of the International...

The Medicines and Healthcare products Regulatory Agency (MHRA) is inviting members of the public to provide their views on proposals for the approach to recognising CE marked medical devices in Great Britain. We welcome the views from anyone who will be impacted by...

Health Technology Assessment: HTA Coordination Group publishes its 2025 Annual Report The Member State Coordination Group on Health Technology Assessment (HTACG) has published its 2025 Annual Report, providing an overview of the first year of application of the EU...

This guidance aims at supporting applicants in completing the 'Precise scope and Background for a change, and Justification for grouping, worksharing and classification for unforeseen changes (if applicable)' (hereinafter called the 'Precise scope') section of the...

The 4th edition of the Guide to Quality in Analytical Chemistry, has been published by Eurachem on 6 February 2026. This widely used guide provides laboratories with practical best-practice guidance for analytical operations, covering both qualitative and quantitative...

The ICH M15 Guideline, General Principles for Model-informed Drug Development, has been adopted (Step 4 of the ICH harmonisation process) and will now enter the implementation phase (Step 5).  Prior to the development of the M15 Guideline, a lack of common standards...

  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 management system. This guidance: · Describes “computer software...

The FDA’s Center for Drug Evaluation and Research (CDER) has released its 15th annual New Drug Therapy Approvals report, offering a useful snapshot of the pace and direction of drug development in 2025. In 2025, CDER approved 46 new drugs never before approved or...

Medical device/medtech regulatory updates this week: The MDSAP Audit Approach (MDSAP AU P0002.010) A few suggested next steps if you're impacted here: 1/ Audit your audit program. Your internal audit procedures and checklists likely reference QSR language and clause...

  This document supersedes “Clinical Decision Support Software” issued on January 6, 2026.   The Food and Drug Administration (FDA) has long regulated software that meets the definition of a device in section 201(h) of the Federal Food, Drug, and Cosmetic...

The U.S. Food and Drug Administration (FDA) has published “Cybersecurity in Medical Devices: Quality Management System (QMS) Considerations and Content of Premarket Submissions” updated guidance issued 3 February 2026. This guidance replaces the 2025 edition and...

The FDA's updated compliance program manual page: https://www.fda.gov/medical-devices/quality-and-compliance-medical-devices/center-devices-and-radiological-health-cdrh-compliance-programs

Feb 02, 2026 marks the end of the 2‑year transition and the beginning of a globally aligned quality era, harmonized with ISO 13485:2016 👉 As of TODAY, all FDA-regulated companies must comply. If you manufacture, design, or distribute FDA-regulated medical...

EMA Releases ICH M11: A New Era for Clinical Study Protocols The EMA has published the ICH M11 guideline, introducing a harmonised, structured and digital-ready template for clinical study protocols — a major step forward for global clinical research. 🔹...