NOTICIAS

  A World Health Organization (Organização Mundial da Saúde) acaba de lançar as "Orientações das Melhores Práticas para Ensaios Clínicos", com recomendações práticas para tornar os ensaios clínicos mais eficientes, éticos e inclusivos.

No passado 21 de maio  decorreu em Lisboa a formação prática sobre o PLANO de GARANTIA DE ABASTECIMENTO, conduzida por Sónia Rei, Diretora Técnica na Hikma Farmacêutica (Portugal) Recohecendo a relevância do cumprimento das novas obrigações dos TAIMS de elaborar e...

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...

The International Medical Device Regulators Forum (IMDRF) has released its updated Standard Operating Procedures (IMDRF/MC/N2FINAL:2025, Edition 13 Version 2). This critical document lays out the framework for how international medical device regulatory convergence is...

On 13 May 2025, the European Commission adopted Regulation (EU) 2025/877, amending the Cosmetic Products Regulation., and strengthening the safety of cosmetics by banning certain CMR (carcinogenic, mutagenic, or toxic for reproduction) substances. The regulation is...

The Council for International Organizations of Medical Sciences (CIOMS) has issued a draft report detailing a set of best practices to guide the integration of artificial intelligence in pharmacovigilance (PV) activities.   The report highlights that a crucial...

The EU AI Office just published its AI Literacy - Questions & Answers.

ICH M13B Guideline is intended to provide recommendations (BE) studies for one or more additional strengths of a drug product in an application where in vivo BE has been demonstrated for at least one of the strengths. The guideline is applicable during both...

The European Medicines Agency (EMA) has published a concept paper (EMA/INS/GMP/48771/2025) outlining proposed revisions to Part IV of the GMP guidelines specific to Advanced Therapy Medicinal Products (ATMPs). This revision aims to bring ATMP GMP guidance in line with...

Nos  días 6 e 7 de maio  decorreu a edição nº 23 da formação mais sólida e relevante no mercado portugues sobre as BOAS PRÁTICAS de DISTRIBUIÇÃO de MEDICAMENTOS e substâncias ativas. Uma formação essencial para todos os profissionais com atividades GDP , que abrange...

Team-NB has released Version 3 of its Position Paper on the submission of technical documentation according to Annex II and III of the Medical Device Regulation (EU) 2017/745. 📄 Explore the full Position Paper: https://lnkd.in/d3iSj4va

EMA and the Heads of Medicines Agencies (HMA) have published a joint workplan "Data and AI in medicines regulation to 2028". It sets out how the European medicines regulatory network plans to leverage large volumes of regulatory and health data as well as new tools to...

The European Medicines Agency (EMA) has published an updated guidance on Product Management Service (PMS) - Implementation of International Organization for Standardization (ISO) standards for the identification of medicinal products (IDMP) in Europe. The guidance has...

A new revision of the Manufacturer Incident Report Form has been published. Manufacturers have till November 2025 to implement this revision in their system: https://lnkd.in/dAZ3XSZx

FDA’s generic drug Science and Research Program, created under the Generic Drug User Fee Amendments (GDUFA), is an essential component of FDA’s mission to protect and promote public health. The Science and Research Program is implemented through extensive research...

This reflection paper describes components to be put in place to realise an EU-wide solution in which  ePI could be easily accessed by citizens wherever they are in Europe, in their preferred language when  available. It calls on stakeholders to take action and invest...

Published by AT - Autoridade Tributária e Aduaneira. 2025   Portugal has implemented the Tax Incentive for Scientific Research and Innovation (IFICI). This scheme aims to attract talent , to promote scientific research  and innovation in the country. The...

This document contains the details of how Legacy Devices are identified in EUDAMED and how you can register a Legacy Device in EUDAMED   EUDAMED user guide Legacy Devices registration Playground v 3.11.0 2025

Regulation (EU) 2017/745 on medical devices and Regulation (EU) 2017/746 on in vitro diagnostic medical devices introduce an EU identification system for medical devices based on a Unique Device Identifier (UDI). The UDI-DI/Device module of EUDAMED is used for the...

According to the Medical Devices legislation, Old and custom-made devices (OCM) are not to be registered in the UDI/Devices module but are to be referenced in Vigilance reports. Old Device: Devices placed on the market according to the medical devices Directives or...

For the current EUDAMED Playground release, the following types of reports can be managed: • MIR (Manufacturer Serious Incident Report) • FSCA (Field Safety Corrective Action) • PSUR (Periodic Safety Update Report) • NCAR (National Competent Authority Report) • MTR...

    EUDAMED user guide .Market Surveillance Playground v 3.11.0 2025

The scope of this guidance document is limited to the information participating IMDRF Regulatory Authorities require in medical device regulatory review reports, the format of reports, and the information necessary for participating IMDRF RAs to effectively use the...

Team-NB members adopted, at the unanimity of the presents, a paper prepared by the 30 members of the task force with the aim to provide an overview of the Team-NB perspective on the challenges of the AI Act with particular attention to its implementation....

Team-NB members adopted, at the unanimity of the presents, a common paper aimed at describing in detail the pre-application and application and Post application phases processes through which manufacturers may apply to Notified Bodies (NBs) for the certification of...

  The following guideline outlines the stability data expectations for drug substances and drug products. This guideline is applicable to marketed drug products, including those associated with registration and lifecycle/post-approval changes and, when...

" Foi enriquecedora e bem estruturada. Os conteúdos abordados foram pertinentes e aplicativos à prática, proporcionando uma visão clara dos princípios e requisitos essenciais . Uma experiência  muito recomendável para quem deseja aprofundar os seus conhecimentos sobre...

“Foi uma formação muito esclarecedora, quer pela informação fornecida, quer pelos exemplos de apoio e principalmente pela troca de experiência entre colegas e formador. “ GROVIDA   No dia 3 de abril realizou-se  a 8 ª edição da formação GMP CANÁBIS : Visão...

Discussions about potential solutions addressing respective evidence needs to support decision making across the life cycle must acknowledge the difference in scopes between marketing authorisation, including potential orphan maintenance applications as applicable,...

  “Gostei da integração dos exercícios com a informação teórica. O facto da grupa ser pequeno foi propício a muita comunicação entre as partes. Formadora muito acessível e eloquente . “ DAIICHISANKYO   Dando seguimento ao sucesso das anteriores edições , no ...

No passado dia 20 de março de 2025, tivemos a primeira edição da formação NOVEL FOODS : Autorização, fabrico e comercialização de Novos Alimentos e ingredientes.uma formação específica para profissionais da indústria dos Suplementos Alimentares , desdenhada em...

This document provides guidance on: • the criteria to be used for deciding when to exchange information, • the procedures to follow when exchanging information, • the forms to use for exchanging information, • the requirements for IMDRF members participation in the...

Durante o passado mês de Fevereiro decorreu a primeira edição do curso SISTEMA DE GESTÃO DA QUALIDADE em contexto de Distribuição Farmacêutica conduzida por Sónia Rei, Diretora Técnica, da Hikma Farmacêutica (Portugal) Uma Formação Avançada de refreshing para...

This document provides high-level strategies for developing regulatory reliance  programs for medical devices, along with specific considerations and steps related to  actual program implementation. It is intended to be equally applicable to all medical devices....

Realizou-se na quinta-feira passada a sessão formativa sobre o PROMOTIONAL REVIEW de SUPLEMENTOS ALIMENTARES; uma sessão com o objetivo de efectuar uma revisão exaustiva sobre os pontos críticos da rotulagem e publicidade de Suplementos Alimentares. Com uma forte...

Decorreu nos dias 26 e 27 de março  , em Lisboa,  a formação "AUDITORIA INTERNA da QUALIDADE, uma formação  para os responsáveis das auditorias internas para a atualização e aprofundamento de conhecimentos e competências A formação , conduzida pela reconhecida...

Interim report on the experience with the pilot from February 2023 to December 2024 The advice is provided by Expert Panels. This is the first time in the European Union (EU) that manufacturers have access via a dedicated regulatory procedure to experts that will...

This guidance document addresses a number of questions which marketing authorisation holders (MAHs) may have on post-authorisation procedures. It provides an overview of the Agency’s position on issues, which are typically addressed in discussions or meetings with...

The purpose of this new harmonised guideline is to introduce the clinical protocol template and the technical specification to ensure that protocols are prepared in a consistent fashion and provided in a harmonised data exchange format acceptable to the regulatory...

"Novel" drugs are new drugs never before approved or marketed in the U.S. See Drugs@FDA for information about all of CDER’s approved drugs and biological products.   In 2024, CDER approved 50 new drugs never before approved or marketed in the U.S., known as...

The transition in the European Union (EU) regulatory landscape for medical devices (MDs) and in vitro diagnostic medical devices (IVDs) to the Regulations ((EU) 2017/745 and (EU) 2017/746) brings with it a large step-up in the volume of documented evidence required to...

Foi publicado em Diário da República o Decreto-Lei n.º 23/2025, de 19 de março, que assegura, na ordem jurídica portuguesa, a execução do Regulamento n.º (CE) 1223/2009, relativo aos produtos cosméticos O diploma ora publicado ao assegurar a execução da legislação...

No passado dia 20 de março de 2025, tivemos a primeira edição da formação  Gestão de Alterações aos termos de AIM,  uma formação específica para os profissionais da área regulamentar, focada nas novidades que introduz a nova legislação no que respeita a revisão da...

“A formação permiutiu consolidar matéria e esclarecer dúvidas relativamente a casos práticos. Os casos práticos foram muito úteis e esclarecedores para consolidar casos práticos. “ LABORATÓRIOS ATRAL Teve lugar no dia 21   a formação Pontos chave do desenho e...

Vigilance reports are a crucial part of a systematic and integrated post-market surveillance (PMS) system established through the Medical Devices Regulation (EU) 2017/745 (MDR) and the In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746 (IVDR) to ensure the...

In this joint discussion paper, the European medical technology industry, represented by MedTech Europe, AESGP, COCIR, EEAR, EUROM and FIDE, makes the case for a reform of the European regulatory system for medical devices (MDs) and in vitro diagnostic medical devices...

The European medicines agencies network strategy to 2028 is available below. The strategy equips the European medicines regulatory network to respond to change and address challenges such as public health emergencies and threats, including antimicrobial resistance. It...

This guidance, relating to the application of Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR) addresses the classification of in vitro diagnostic medical devices (IVDs) and provides clarifications on the classification rules as set out under...

This flowchart, co-signed by AESGP, COCIR and MedTech Europe (the Associations), has been developed to support companies in implementing a structured decision-making process in accordance with the requirements of Article 10a MDR/IVDR, introduced by Amending Regulation...

The ECA Foundation has recently released Version 3.0 of its Good Practice Guide for Qualification and Validation

This report offers both a cross-sectoral overview and a detailed sector-by-sector analysis of the criticality and maturity of assessed sectors. Building on the insights gathered, it highlights the strengths of and challenges faced by each sector assessed, identifies...