NOTICIAS
MDCG 2019-6 Rev5 Questions and answers: Requirements relating to notified bodies Revision 5 – February 2025
This document presents questions and answers on requirements relating to notified bodies under Regulation (EU) 2017/745 on medical devices (MDR) and Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR). The issues covered by this document have been...
Formação, Alteração e Revisão Anual de PREÇOS de MEDICAMENTOS: “Formação muito enriquecedora sobre o tema”
Realizou-se mais uma edição da formação sobre a Formação, Alteração e Revisão Anual de PREÇOS de MEDICAMENTOS,: Um guia completo para o desenvolvimento da estratégia de pedido de preço máximo, de preço notificado e de revisão anual de preços de Medicamentos de Uso...
EU Cosmetics Deadlines – New Rules Effective 01 February 2025
EU Cosmetics Deadlines – New Rules Effective 01 February 2025 In early 2024, the EU announced new restrictions and bans on certain substances in cosmetics, including updates to Annex II and Annex III. Starting February 1, 2025, certain deadlines will take effect...
Biomanufacturing: Europe’s Industrial Future
Published today, the "Biomanufacturing: Europe's Industrial Future" paper explores the current status and future options and opportunities for biomanufacturing in Europe, underpinned by data and examples. Industry across sectors face challenges in reducing the...
Plataforma europeia de monitorização da escassez de medicamentos entrou em funcionamento
A Plataforma Europeia de Monitorização da Escassez de Medicamentos (ESMP, na sigla em inglês) foi lançada no dia 29 de janeiro de 2025 e visa reforçar a capacidade de controlo da disponibilidade de medicamentos em toda a União Europeia (UE), permitindo a notificação e...
FDA Proposes Framework to Advance Credibility of AI Models Used for Drug and Biological Product Submissions
the U.S. Food and Drug Administration issued draft guidance to provide recommendations on the use of artificial intelligence (AI) intended to support a regulatory decision about a drug or biological product’s safety, effectiveness or quality. This is the first...
IMDRF Characterization Considerations for Medical Device Software and Software-Specific Risk
Software’s role in healthcare is becoming increasingly critical, as a diverse array of products serves various medical and administrative functions across clinical and private settings. A subset of software that is used in healthcare is regulated as a medical device...
Commission publishes the Guidelines on prohibited artificial intelligence (AI) practices, as defined by the AI Act.
These guidelines provide an overview of AI practices that are deemed unacceptable due to their potential risks to European values and fundamental rights. The AI Act, which aims to promote innovation while ensuring high levels of health, safety, and fundamental rights...
Accelerated Approval and Considerations for Determining Whether a Confirmatory Trial is Underway
For drugs granted accelerated approval, sponsors have been required to conduct confirmatory studies postapproval to verify and describe the anticipated effect on irreversible morbidity or mortality or other clinical benefit. In the Consolidated Appropriations Act,...
Considerations for Complying With 21 CFR 211.110 Guidance for Industry
This guidance, when finalized, will describe considerations for complying with the requirements in 21 CFR 211.110 to ensure batch uniformity and drug product integrity. In addition, this guidance discusses related quality considerations for drug products that are...
Final version of its Guideline for Good Clinical Practice E6(R3). Adopted on 6 january 2025
ICH News!! (Good Clinical Practice Guideline E6(R3)) The International Council for Harmonisation (ICH) has today (14 January) announced the adoption of the final version of its Guideline for Good Clinical Practice E6(R3). This update is a major milestone in global...
New EU rules for health technology assessments become effective
EMA is ready to support the implementation of the new regulation on health technology assessment (HTAR) (Regulation (EU) 2021/2282) when it becomes applicable on 12 January 2025. The regulation is an important step forward in accelerating and widening access to new...
ICH Q4B(R1) Guideline on evaluation and recommendation of pharmacopoeial texts for use in the ICH regions Step 5
This document describes the process for the evaluation and recommendation of selected pharmacopoeial texts to facilitate their recognition by regulatory authorities for use as interchangeable by the ICH regulatory members. This process was initially under the...
Inter-association joint position paper on Electronic Product Information
In a significant stride towards further modernizing patient care, regulatory efficiency, and environmental sustainability, Pharmaceutical Industry Associations (AESGP, EFPIA, and Medicines for Europe) have launched a new series of position papers advocating for the...
MDCG 2023-3 rev.2 – Questions and Answers on vigilance terms and concepts as outlined in the Regulation (EU) 2017/745 under Regulation (EU) 2017/746 – January 2025
This document aims to clarify important terms and concepts that are outlined in Section 2 of Chapter VII of Regulation (EU) 2017/745 on medical devices (MDR) and Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR). Establishing a common...
Considerations for the Use of Artificial Intelligence To Support Regulatory Decision-Making for Drug and Biological Products
This guidance provides recommendations to sponsors and other interested parties on the use of artificial intelligence (AI) to produce information or data intended to support regulatory decision-making regarding safety, effectiveness, or quality for drugs....
Accelerated Approval and Considerations for Determining Whether a Confirmatory Trial is Underway
For drugs granted accelerated approval, sponsors have been required to conduct confirmatory studies postapproval to verify and describe the anticipated effect on irreversible morbidity or mortality or other clinical benefit. In the Consolidated Appropriations Act,...
Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations
This draft guidance document provides recommendations regarding the contents of marketing submissions for devices that include artificial intelligence (AI)-enabled device software functions including documentation and information that will support FDA’s evaluation of...
9 ways to maximise the impact of the future EU Framework Programme for Research and Innovation (FP10)
Ahead of the discussions on the EU future Framework Programme for Research and Innovation (FP10), EFPIA is putting forward nine recommendations to help maximise its impact. “Implementing these recommendations would not only optimise the investment in R&I but also...
Advanced Manufacturing Technologies Designation Program: FDA Guidance for Industry – December 2024
In the pharmaceutical industry, advanced manufacturing signifies an innovative approach or technology aimed at enhancing the reliability and robustness of the manufacturing process and supply chain. This advancement facilitates timely access to quality medicines by...
Guidance for Industry: Registration and Listing of Cosmetic Product Facilities and Products
This guidance provides recommendations and instructions to assist persons submitting cosmetic product facility registrations and product listings to FDA. This guidance document explains, among other things: The statutory requirement to submit cosmetic product facility...
Protocol Deviations for Clinical Investigations of Drugs, Biological Products, and Devices
This guidance provides recommendations to assist sponsors, clinical investigators, and institutional review boards (IRBs) in defining, identifying, and reporting protocol deviations in clinical investigations. FDA regulations do not include a definition of the term...
Second Draft of the General-Purpose AI Code of Practice published, written by independent experts
Independent experts present the second draft of the General-Purpose AI Code of Practice, based on the feedback received on the first draft, published on 14 November 2024. GettyImages © Khanchit Khirisutchalual Each draft is a work in progress and reflects the views of...
MDCG 2022-3 rev.1 – Verification of manufactured class D IVDs by notified bodies (December 2024)
This document aims to provide guidance to notified bodies to clarify their role and responsibilities in relation to samples of manufactured class D devices or batches of devices in accordance with Annexes IX and XI of the IVDR. This guidance also describes best...
Relatório Especial 23/2024: Rotulagem dos alimentos na UE – Um labirinto de rótulos onde os consumidores se podem perder
Os rótulos fornecem aos consumidores informações sobre o conteúdo dos alimentos e ajudam‑nos a tomar decisões de compra informadas. O Tribunal conclui que a rotulagem dos alimentos na UE pode ajudar os consumidores a tomarem decisões de compra mais informadas quando...
European Shortages Monitoring Platform enables better monitoring of shortages in the EU
The European Shortages Monitoring Platform (ESMP) has gone live with a core set of functionalities. Using this first version of the ESMP, marketing authorisation holders (MAHs) can now submit data to routinely report shortages of centrally authorised medicines. This...
TEAM NB MDR Certification Process (including Pre-application, Application and Post Application phases) – Consensus document
Purpose and Scope The purpose of this consensus document is to describe in detail the pre-application, application processes through which manufacturers may apply to Notified Bodies (NBs) for the certification of medical devices under the regulation (EU) 2017/745...
A common EU approach to data transparency in medicine regulation
EMA and HMA (Heads of Medicines Agencies) have published a comprehensive overhaul of their guidance on the identification of commercially confidential information (CCI) and personal data in marketing authorisation applications for human medicines. The update reaffirms...
Global Unique Device Identification Database (GUDID)
The Food and Drug Administration (FDA) is responsible for protecting the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products, medical devices, the nation’s food supply, cosmetics,...
ICHM13A guideline comes in force on 25 January 2025 Investigation of bioequivalence – Scientific guideline
This guidance specifies the requirements for the design, conduct, and evaluation of bioequivalence studies for immediate release dosage forms with systemic action. The ICHM13A Guideline is the first guideline in a foreseen ICH series describing the scientific and...
Products Management Services – Implementation of International Organization for Standardization (ISO) standards for the identification of medicinal products (IDMP) in Europe
The PMS and SMS will manage two of the four domains of substance, product, organisation and referentials (SPOR) master data in pharmaceutical regulatory processes. SPOR data management services will facilitate the reliable exchange of medicinal product information in...
ePI pilot report :Experience gained from creation of ePI during regulatory procedures for EU human medicines
Electronic product information (ePI) for European Union (EU) medicines will benefit patients and healthcare professionals (HCPs) by providing up-to-date information on safe and effective use at the point of need. It contributes to the objectives of the European...
Embalagens Multilingue
Publicado no site INFARMED O Infarmed promove e incentiva o uso de embalagens multilingue atendendo à necessidade de garantir o acesso pelos doentes e profissionais de saúde aos medicamentos. Assim o Infarmed convida à consulta das recomendações constantes das...
Implementation of the Regulation on health technology assessment
The Regulation (EU) 2021/2282 on health technology assessment (HTAR) entered into force on 11 January 2022 and will apply from 12 January 2025. In the preparatory phase for the implementation of the HTAR (January 2022 – January 2025), this webpage aims at informing...
Revisão do Regulamento Europeu relativo a alterações aos termos da AIM
Publicado no site infarmed Circular Informativa N.º 106/CD/100.20.200 Data: 13/12/2024 A 1 janeiro de 2025 entrará em vigor a revisão do Regulamento Europeu relativo a alterações aos termos das autorizações de introdução no mercado (AIM) - Regulamento Delegado...
THE INFORMATION OBLIGATION IN CASE OF INTERRUPTION OR DISCONTINUTION OF SUPPLY OF CERTAIN MEDICAL DEVICES AND IN VITRO DIAGNOSTIC MEDICAL DEVICES
Q&A on practical aspects related to the implementation of the obligations to inform about interruption or discontinuation of supply of certain devices laid down in Article 10a MDR and IVDR as introduced by Regulation (EU) 2024/1860 of 13 June 2024 amending...
Qualificação de FORNECEDORES: ” Formação bem estruturada, com muita informação “
Decorreu no 6 de dezembro uma nova edição da formação Qualificação de FORNECEDORES ,Clientes e Entidades Subcontratadas, conduzida por Teresa Cruz, da MTA Pharma A formação ofereceu uma análise pormenorizada do processo de qualificação de fornecedores e clientes, para...
Análise da composição de SA : INGREDIENTES de SUPLEMENTOS ALIMENTARES:” Formação muito bem organizada, explícita e completa”
.-.- “Formação muito prática e completa . A Rita apresentou os temas de forma muito clara , esclarecendo todas as dúvidas e com exemplos práticos . Sem dúvida uma mais valia para a consolidação de conhecimentos sobre a formulação e análise de suplementos...
Smooth transition to the mandatory use of EUDAMED
In the light of the anticipated go-live of most European database on medical devices (EUDAMED) modules in 2025, MedTech Europe summarises in a position paper the industry viewpoints on the smooth transition to the mandatory use of the European database for medical...
BPD MEDICAMENTOS : “Formação excelente com conteúdo rico e casos práticos estimulantes”
Obrigado a todos os que participaram na última edição da formação BOAS PRÁTICAS DE DISTRIBUIÇÃO DE MEDICAMENTOS, os dias 3 e 4 de dezembro . Ao longo das 14 horas de formação dinamizadas pela formadora Sónia Rei, foram analisados em pormenor e todos os pontos...
AUDITORIA INTERNA, nível avançado :”Muito prático, sem dúvida com utilidade no dia-a-dia “
"Formação muito útil , com exemplos práticos . Formadora muito acessível e disposta a tirar dúvidas . Evento bem organizado. “ GENIBET No passado dia 5 de dezembro decorreu em Lisboa a formação AUDITORIA INTERNA, nível avançado desenhada com o objetivo de...
Como implementar, manter e rever o Sistema CAPA: “Ótima formação com partilha de exemplos reais e práticos”
“Formação importante na consolidação de conhecimentos e esclarecimento de questões de ordem prática e do dia-a-dia. “ LABORATÓRIOS AZEVEDOS Decorreu mais uma edição da formação "Como implementar, manter e rever o Sistema CAPA " O workshop apresentou os conceitos e...
510(k) Third Party Review Program and Third Party Emergency Use Authorization (EUA) Review
This guidance outlines FDA's current thinking on key aspects of the 510(k) Third Party Review Program and third party review of Emergency Use Authorization (EUA) requests by describing FDA's expectations for the review of 510(k) submissions and EUA requests by third...
Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence-Enabled Device Software Functions
FDA is issuing this guidance to provide recommendations for predetermined change control plans (PCCPs) tailored to artificial intelligence (AI)-enabled devices. The recommendations in this guidance are intended to support iterative improvement through modifications to...
Total Product Lifecycle Considerations for Generative AIEnabled Devices
While interest in generative artificial intelligence (GenAI) tools across the health care sector has expanded rapidly, there remain open questions on the approach to regulating GenAI-enabled products that may fall within FDA’s jurisdiction, including, but not limited...
MDCG 2024-15 – Guidance on the publication of the clinical investigation reports and their summaries in the absence of EUDAMED (November 2024)
Article 77(5) MDR requires that the sponsor submits to the Member States in which a clinical investigation was conducted a clinical investigation report within one year of the end of the clinical investigation or within three months of the early termination or...
Team-NB High level position on the regulatory framework for the medical devices sector
The European Association of Medical devices Notified Bodies (Team-NB) and its members fully support the objectives of the MD and IVD Regulations (MDR and IVDR) which aim to “establish a robust, transparent, predictable and sustainable regulatory framework for medical...
CONTROLO DE ALTERAÇÕES : Sessão esclarecedora com uma discussão bastante interessante sobre o assunto
Decorreu no 26 de novembro a edição 2024 da formação CONTROLO DE ALTERAÇÕES, conduzida por Sara Cunha , CHC & GEM Quality Business Partner, da Sanofi Uma excelente formação , apresentada com muita clareza e casos práticos que permitem pôr em prática os...
EU Prosperity and Competitiveness: Recommendations for implementing the EU Green Deal in Healthcare
Posted on 11.11.2024 by MedTech Europe MedTech Europe envisions a future where healthcare systems are environmentally and financially sustainable, equitable and resilient to future crises. In light of the European Commission’s announced Sustainable Prosperity and...
Consultation on ICH E6 (R3) Guideline for Good Clinical Practice Annex-2
Recentrly published ICH E6 (R3) Annex 2 draft, now released for public consultation! For the purposes of Annex 2, decentralised elements in a clinical trial are those trial-related activities conducted outside the investigator’s location (e.g., trial visit is...
Revision of the Cosmetic Products Regulation
Consumers are exposed to chemicals present in cosmetics. Any cosmetic product sold on the EU market must comply with the rules set up by Regulation (EC) No 1223/2009 of the European Parliament and of the Council of 30 November 2009 on cosmetic products (the Cosmetic...