NOTICIAS

the U.S. Food and Drug Administration issued draft guidance to provide recommendations on the use of artificial intelligence (AI) intended to support a regulatory decision about a drug or biological product’s safety,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...

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...

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...

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,...

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...

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...

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...

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...

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...

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...

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....

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,...

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...

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...

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...

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...

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...

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...

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...

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...

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...

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...

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...

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,...

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...

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...

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...

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...

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...

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...

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...

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...

.-.-  “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...

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...

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...

"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...

“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...

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...

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...

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...

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...

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...

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...

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...

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...

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...

This questionnaire was prepared in accordance with the request of MDCG, published in the Medical Device Coordination Group (MDCG) position paper in August 2022, for notified bodies to develop common guidance for manufacturers to assist them in the application phase...

In September 2024, the European Union (EU) published Commission Delegated Regulation (EU) 2024/2564 of June 19, 2024 to revise Regulation (EC) No 1272/2008 on classification, labeling and packaging of substances and mixtures (CLP Regulation, consolidated version to...

Q&A on practical aspects related to the implementation of the gradual roll-out of Eudamed pursuant to the MDR and IVDR, as amended by Regulation (EU) 2024/1860 amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards a gradual roll-out of Eudamed, the...

Independent experts present the first draft of the General-Purpose AI Code of Practice, which will be discussed with around 1000 stakeholders next week. The AI Office is facilitating relevant AI Act understanding with dedicated questions and answers for stakeholders....

Decorreu  a edição número 14 da formação sobre as BOAS PRÁTICAS DE DISTRIBUIÇÃO de DISPOSITIVOS MÉDICOS; uma formação dinâmica, super interessante donde foram abordados os temas de forma prática e concisa e adaptadas às várias realidades . Uma formação essencial para...