NOTICIAS

Mandatory requirements for additional product information  for medical devices (MDs) and in vitro diagnostic medical devices (IVDs) have exponentially increased recently. Under the current legislative system in the EU, both essential information (information needed...

The regularization of medical equipment and software as a medical device at ANVISA is a crucial process for ensuring safety and efficacy in healthcare technology. The Management of Medical Equipment Technology, known as GQUIP, plays a vital role in this regulation....

The FDA just issued final revised guidance explaining how sponsors can get preliminary, non-binding FDA feedback on a product’s regulatory identity (drug, device, biologic, or combination) and Center assignment (CDER, CDRH, or CBER). It replaces the Feb 2018 version...

Nesta semana decorreu mais uma edição da formação exclusiva da Formiventos CTD MODULO 3, bajo o lema : Uma revisão exaustiva de todos os pontos críticos a considerar para  garantir o cumprimento dos requisitos regulamentares e  atingir  os melhores prazos de resposta...

  No passado dia 31 de outubro decorreu em Lisboa a 6 edição da formação exclusiva da Formiventos : Sistema de Preços de Medicamentos de Uso Humano no SiNATS: Formação, Alteração e Revisão de Preços,conduzida por Jalmira Mulchande, Founding Partner and General...

FDA publishes final guidance on Alternative Assessment Tools for Pharmaceutical Manufacturers 📅 09/2025   The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled “Alternative Tools:...

The Food and Drug Administration (FDA or agency) is issuing this draft guidance to provide guidance to industry and FDA staff about the expectations for quality management system regulation (QMSR) requirements for premarket submissions once the final rule amending 21...

Decorreu no dia 28 de outubro  a formação exclusiva da Formiventos  FARMACOVIGILÂNCIA avançada  , desenhada para consolidar e atualizar conhecimentos e permitir o reforço dos sistemas implementados nas organizações “Excelente! Organizada e abrangente ! Foi bom parar...

Present day healthcare systems face several complex challenges, including rising demand due to an aging population, increasing prevalence of chronic and complex conditions, rising costs, and shortages in the healthcare workforce. Artificial intelligence (AI) has the...

No passado 22 de outubro de 2025, decorreu em Lisboa uma nova edição da formação Boas Práticas de Fabrico . GMP 2025,  uma formação muito interativa com uma profissional muito competente e excelente formadora, sendo  uma ótima oportunidade para uma partilha de ideias...

FDA GUIDANCE SNAPSHOT: Conducting Clinical Trials With Decentralized Elements. Guidance for Industry, Investigators, and Other Interested Parties This guidance provides FDA’s recommendations for sponsors, investigators, and other interested parties regarding the...

COMMISSION IMPLEMENTING REGULATION (EU) 2025/2086 of 17 October 2025 laying down, pursuant to Regulation (EU) 2021/2282 on health technology assessment, procedural rules for the interaction during, exchange of information on, and participation in, the preparation and...

Manufacturing issues are the leading cause of medicine shortages in the EU/EEA (50.6%), followed by unexpected demand increases (16.7%), commercial reasons (11.2%) and distribution problems (10.6%). Quality and regulatory issues, safety and unforeseen events account...

Oct 16, 2025 The new version of EUDAMED 2.18.0 has been deployed.

24 September 2025 The ICH E2D(R1) Guideline on “Post-Approval Safety Data: Definitions and Standards for Management and Reporting of Individual Case Safety Reports” has reached Step 4 of the ICH Process on 15 September 2025 and has now entered the implementation phase...

Shortages of medicines are a global issue and a critical public health challenge that is at the top of the agenda of EU policymakers, regulators and healthcare providers. The World Health Organization (WHO) and various health authorities worldwide have acknowledged...

As defined in the Joint HMA-EMA Network Data Steering Group mandate, the European medicines regulatory network handles a wide spectrum of data that is received, processed, generated, managed and analysed to ensure that decisions on medicines are well-informed and...

These guidelines provide a rationale for recommendations of the Committee of Experts on the Classification of Medicines as Regards their Supply (CD-P-PH/PHO) on the classification of supply of active substances for human use. They describe the assessment approach...

Publicado por FARMAINDUSTRIAL El Consejo de Ministros ha aprobado el real decreto que regula por primera vez el uso del cannabis medicinal en España, permitiendo su formulación hospitalaria y prescripción por especialistas para determinadas patologías en las que otros...

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...