NOTICIAS

FAQs How to submit an annual safety report and respond to related RFIs CTIS Training Programme – Module 18 Version 1.2 – March 2025

What does the Critical Medicines Act aim to achieve and how? The Critical Medicines Act aims to address the issues above, by: strengthening Europe's manufacturing capacity; diversifying supply chains; reducing the EU's dependencies; incentivising resilience;...

Publicado no site infarmed Circular informativa n.º 022/CD/100.20.200 de 11/03/2025 Foram atualizadas as listas anexas ao Regulamento sobre notificação prévia de transações de medicamentos para o exterior do país: Lista de medicamentos cuja exportação, ou distribuição...

Towards the Health Union’s goal to ensure that all EU patients have the medicines they need, when they need them CRITICAL MEDICINES ACT AIMS TO: ▶ Facilitate investments for companies that increase EU manufacturing of critical medicines ▶ Incentivise...

Artificial Intelligence and Medical Products: How CBER, CDER, CDRH, and OCP are Working Together (March 2024, Revised February 2025) CDER is committed to ensuring that drugs are safe and effective while facilitating innovations in their development. FDA published a...

Foram publicadas em Diário da República as novas deliberações do Infarmed relativas à gestão da disponibilidade e exportação de medicamentos. As novas regras aplicam-se aos titulares de Autorização de Introdução no Mercado, distribuidores grossistas, farmácias...

What’s new in this global health strategy, the GPW 14? Building on the evaluation of WHO’s Thirteenth General Programme of Work, 2019-2025 (GPW 13), the 2023 global monitoring report on UHC (2023)3 and lessons learned from the COVID-19 pandemic, GPW 14: (i) sets a...

This document provides answers to frequently asked questions regarding the European Health Data Space (EHDS) Regulation 2025/327   Frequently Asked Questions on the European Health Data Space Last updated 5 March 2025

Teve lugar nos dias 26 e 27 de fevereiro  uma nova edição da formação exclusiva da Formiventos : GDP Nível 2 : BOAS PRÁTICAS DE DISTRIBUIÇÃO Nível Avançado; uma Formação Avançada, de alto valor acrescentado, para a atualização e aprofundamento de conhecimentos e...

      REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on the European Health Data Space and amending Directive 2011/24/EU and Regulation (EU) 2024/2847   The aim of this Regulation is to establish the European Health Data Space (EHDS) in...

Publicado no site Infarmed Circular Informativa n.º 012/CD/100.20.200 de 21/02/2025 Foi publicada a Deliberação n.º 234/2025, de 18 de fevereiro, que aprova o Regulamento sobre o controlo de transações de medicamentos para o exterior do país e atualiza os fatores para...

“Uma abordagem teórico-prática completa sobre um tema super importante para a elaboração e avaliação do Módulo 3 do dossier de AIM. “ ALL4COMPLIANCE Decorreu no dia  26 de fevereiro , em Lisboa,  a formação   CTD MODULO 3  bajo o lema " Uma revisão exaustiva de todos...

Germany, February 2025 - BioTech Brief: Making Europe fit for the future. This BioTech Letter focuses on biotechnology regulation and was published by the German Association of Biotechnology Industries within the German Chemical Industry Association - VCI. "In early...

WHO through one of its flagship publications, the European Health Report, supports countries by providing a call to action and guiding framework. The 2024 edition of the European Health Report shows that people’s health in the WHO European Region continues to be...

The goal of this compliance program's activities is to ensure that establishments consistently produce drug products of acceptable quality and minimize consumers' exposure to adulterated drug products. Under this compliance program, inspections, investigations, sample...

No passado 19 de fevereiro decorreu mais uma edição da formação QUALIFIED PERSON Update 2025 bajo o lema : Uma revisão completa  do impacto das novas Regulamentações no âmbito das GMP de medicamentos  nas Responsabilidades da QUALIFIED PERSON   Uma excelente...

Foram publicadas em Diário da República as novas deliberações do Infarmed relativas à gestão da disponibilidade e exportação de medicamentos. As novas regras aplicam-se aos titulares de Autorização de Introdução no Mercado, distribuidores grossistas, farmácias...

Realizou-se na terça-feira passada a sessão formativa  sobre ROTULAGEM & PUBLICIDADE de PRODUTOS COSMÉTICOS  bajo o lema : Uma visão global da legislação , e com a compilação dos critérios/requisitos necessários para a validação dos materiais promocionais Uma...

Despite the promise of digital health technologies to transform healthcare, (whereby continued work is ongoing to exactly define these technologies and develop a taxonomy), their adoption in clinical practice is very limited, their regulatory environment is still...

This document contains a collection of frequently asked questions that have been submitted by the industry to the DI taskforce. The intention of this documents is that this is a living document that will be updated as new questions are opposed to the group

O Relatório Anual da Gestão da Disponibilidade de Medicamentos de 2024, divulgado pelo INFARMED. I.P., sublinha o papel fundamental da entidade na monitorização e gestão do abastecimento de medicamentos em Portugal. Segundo o relatório, 97% das apresentações de...

This guidance helps sponsors of investigational new drug applications (INDs) and applicants of new drug applications (NDAs), biologics license applications (BLAs), and NDA and BLA supplements as well as abbreviated new drug applications (ANDAs), as applicable, to...

EIT Health has developed this report as an all-encompassing guide to assist healthcare start-ups throughout Europe in navigating the intricacies of the German healthcare system. As a prominent leader in accelerating and supporting innovative healthcare solutions...

This Question and Answer (Q&A) document provides practical considerations concerning the implementation of the medical devices and the in vitro diagnostic medical devices regulations in the context of combinations of medicinal products with medical devices. This...

EMA, in close collaboration with the European Commission, has established a standard procedure for manufacturers of certain high-risk medical devices to request scientific advice on their intended clinical development strategy and proposals for clinical investigation....

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...

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 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...

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...

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...

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...