NOTICIAS

Guidance on harmonised administrative practices and alternative technical solutions until Eudamed is fully functional (for Regulation (EU) 2017/746 on in vitro diagnostic (MDCG 2022-12) This document provides guidance to Member States and other relevant parties on the...

  With a particular focus on artificial intelligence (AI), this study identifies and examines policy options for the EU's data governance framework that align with a data justice perspective. A data justice approach is one that centres on equity, recognition and...

No âmbito da implementação do Regulamento (UE) 2017/746 do Parlamento Europeu e do Conselho, de 5 de abril de 2017, relativo aos dispositivos médicos para diagnóstico in vitro,  foi publicado no Jornal Oficial da União Europeia o Regulamento de Execução (UE) 2022/1107...

Decorreu  no passado dia 29 de junho  uma nova sessão especial dedicada à analisar a evolução da implementação do Novo Regulamento de Ensaios Clínicos, conduzido por  Maria Alexandra Ribeiro, Presidente do CEIC – Comissão de Ética para a Investigação Clínica ; uma...

Thanks to advances in science and technology, the research-based pharmaceutical industry is entering an exciting new era in medicines development. Research methods are evolving and we have many promising prospects on the horizon, with groundbreaking cell and gene...

EUDAMED TIME LINE NEWS: Eudamed has been delayed again; all timelines have been delayed by 1 year and the end of the transition period is now expected in Q2 2026 (instead of Q2 2025)  

THE EUROPEAN COMMISSION, Having regard to the Treaty on the Functioning of the European Union, Having regard to Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive...

Nos dias  28 e 29 de junho de 2022 , teve lugar em Lisboa a edição número 18 da formação sobre as   BOAS PRÁTICAS de DISTRIBUIÇÃO de medicamentos de uso humano e de substâncias ativas , conduzida por Sónia Rei, Diretora Técnica da Hikma Farmacêutica (Portugal) : uma...

Decorreu  no passado dia 28 de junho de 2022, a 8ª edição da formação  Qualificação de Fornecedores ,Clientes e Entidades Subcontratadas  conduzido pela reconhecida especiallista  Dra Teresa Cruz, da  MTA Pharma   Uma formação  objetiva, clara e sucinta sobre...

European collaboration between regulators and health technology assessment bodies Joint work plan (2021-2023) between EMA and European HTA bodies facilitated through EUnetHTA21 Close collaboration between EMA and the EUnetHTA 21 consortium aims to support preparing...

Commission Implementing Regulation (EU) 2022/944 of 17 June 2022 laying down rules for the application of Regulation (EU) 2017/746 of the European Parliament and of the Council as regards the tasks of and criteria for European Union reference laboratories in the field...

EU MDR News!! (MDR Timelines) MDCG 2022-11 - Notice to manufacturers to ensure timely compliance with MDR requirements  With the adoption of Regulations (EU) 2017/745 (MDR) and 2017/746 (IVDR), the regulatory framework for medical devices and in vitro diagnostic...

The European Medicines Agency (EMA) and the Head of Medicines Agencies (HMA) have adopted a  Veterinary Big Data strategy to 2027 outlining their vision for fostering data-driven, digital innovations in the veterinary medicines’ domain in the European Union (EU)....

EMA’s annual report 2021 published today provides an overview of the Agency’s activities to protect and promote public and animal health in the European Union (EU) and highlights EMA’s most significant achievements. These include the Agency’s activities to tackle the...

This Q&A document provides guidance and seeks to support sponsors, clinical trialists and applicants regarding scientific aspects and the planning, set-up, submission for obtaining CT authorisation (CTA), conduct, reporting and transparency, analysis and...

Objectives In recent years, a burgeoning interest in and concern over the use of artificial intelligence (AI) in medicine and healthcare has stood at the centre of interdisciplinary scientific research, political debate, and social activism. The goal of this report is...

Nos passados dias 24 e 26 de maio teve lugar a 4ª edição da formação sobre Novos pedidos de AIM, conduzido pelo Dr. Selmo Pinto, MRP/DCP Process Manager do INFARMED   Uma combinação de teoria e exercícios práticos, para adquirir os  conhecimentos  cruciais para...

Decorreu  no passado dia 25 de maio , a 7ª edição do MASTER COURSE  Autorização, publicidade e comercialização de SUPLEMENTOS ALIMENTARES, conduzido por Helena Vieira ,Directora Técnica e de Assuntos Regulamentares da APARD   Esta formação tem como objetivo...

The Guideline is relevant to antibacterial agents with a direct action on bacteria resulting in inhibition of replication leading to bacterial cell death including: • Antibacterial agents developed as single agents; • Antibacterial agents developed for use in...

Teve lugar   a 1ª edição da Formação da Formiventos exclusiva sobre as  BOAS PRÁTICAS DE DISTRIBUIÇÃO Nível Avançado,  , conduzido pela conceituada especialista  Dra. Sónia Rei , Diretora Técnica da Hikma Farmacêutica (Portugal)   Uma Formação Avançada, de alto...

This guideline concerns the application of Module 3 of Annex I to Directive 2001/83/EC for human herbal medicinal products (HMPs) and Part 2 of the dossier as established by Commission Delegated Regulation (EU) 2021/805 amending Annex II of Regulation (EU) 2019/6 for...

  This guidance is intended to help stakeholders develop, maintain, and implement risk management plans (RMPs) to proactively assist in the prevention of human drug product and biological product shortages. RMPs can provide stakeholders with a framework to...

This document presents questions and answers on the Unique Device Identification system (UDI system) established under Regulation (EU) 2017/745 on medical devices (MDR) and Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR). The questions covered...

Regulation (EU) 2017/746 on in vitro diagnostic medical devices (the IVDR) requires that the manufacturer shall draw up a summary of safety and performance (SSP) for class C and D devices, other than devices for performance studies. The SSP shall be validated by a...

    Regulation (EU) 2022/1121 extended the transitional provisions of Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR), in particular its Article 110(3), in terms of scope and timing. Following the approach set out in the report of the...

This guidance for industry provides the Agency’s current thinking on how to evaluate out-ofspecification (OOS) test results. For purposes of this document, the term OOS results includes all test results that fall outside the specifications or acceptance criteria...

  COMMISSION IMPLEMENTING DECISION (EU) 2022/729 of 11 May 2022 amending Implementing Decision (EU) 2021/1195 as regards harmonised standards for quality management systems and for application of risk management to medical devices   THE EUROPEAN COMMISSION,...

Decorreu  a 7ª Edição Gestão de Reclamações, Devoluções, Falsificados e Recolhas de Mercado,  , conduzido pela conceituada especialista  Dra. Sónia Rei , Diretora Técnica da Hikma Farmacêutica (Portugal) Uma formação especialmente desenhada para fornecer  a informação...

No dia 10 de maio, decorreu mais uma edição da formação exclusiva da Formiventos sobre ROTULAGEM, PACKAGING E PUBLICIDADE de DISPOSITIVOS MÉDICOS   A formação, subordinada ao tema :Optimize a sua estratégia de labelling, packaging e publicidade e garanta a...

Artificial Intelligence (AI) is a branch of computer science, statistics, and engineering that uses algorithms or models to perform tasks and exhibit behaviors such as learning,making decisions and making predictions. The subset of AI known as Machine Learning (ML)...

Teve lugar nos dias  4 e 5 de maio , a 11ª edição da  formação exclusiva da Formiventos sobre as BOAS PRÁTICAS de DISTRIBUIÇÃO de DISPOSITIVOS MEDICOS, bajo o lema :Consiga uma visão abrangente e atualizada dos assuntos  regulamentares e operacionais que garanta um...

PUBLICADO NO SITE INFARMED 28 abr 2022     Foi publicado o Relatório Anual sobre a Gestão da Disponibilidade de Medicamentos, o qual visa apresentar um balanço da atividade desenvolvida e os principais resultados obtidos durante o ano de 2021.   O...

The demarcation between the Regulation (EU) 2017/745 on medical devices (MDR) on the one hand and the Directive 2001/83/EC on the Community code relating to medicinal products for human use (MPD) on the other hand is crucial for the proper implementation of these sets...

Regulation (EU) No 536/20141 61 (hereinafter ‘the Clinical Trials Regulation’ or ‘the Regulation’) repeals Directive 2001/20/EC on Clinical Trials  and establishes a harmonised approach to the submission,  assessment and reporting of clinical trials (CTs) information...

The EU EC have just released a new revision of the EUDAMED Economic Operator user guide, v2.7. How economic operators can use the actor registration module – concept, registration, management, access and mandates.    EUDAMED is the IT system developed by the...

This is an umbrella guidance, and this update/modernization includes important concepts to support and implement other requirments, like quality risk management (from ICH E6). It introduces Quality by Design and Critical to Quality Factors, as appropriate and flexible...

Questions and Answers Document – Regulation (EU) 536/2014 – Version 6 April 2022)

The new MDR 2017/745 and IVDR 2017/746 EU regulations introduce an EU identification system for medical devices based on a Unique Device Identifier (UDI) and require that manufacturers of medical devices submit the UDI/Device information of all devices/products that...

New ICHQ14 guideline is proposed to harmonise the scientific approaches of analytical procedure development, and to provide the principles relating to the description of analytical procedure development process. ICHQ14 is intended to improve regulatory communication...

Teve lugar no dia 30 de março a 4ª edição da formação exclusiva da Formiventos sobre  AUDITORIAS e INSPEÇÃO em FARMACOVIGILÂNCIA conduzida pela reconhecida especialista Dra Elsa Ferrão, da ADAMAS Consulting , com o objetivo de proporcionar aos assistentes bases...

The Regulation (EU) 2017/745 on medical devices  requires that the manufacturer shall draw up a summary of safety and clinical performance (SSCP) for implantable devices and for class III devices, other than custom-made or investigational devices. The SSCP shall be...

The Committee on Herbal Medicinal Products (HMPC) is the European Medicines Agency's (EMA) committee responsible for compiling and assessing scientific data on herbal substances, preparations and combinations, to support the harmonisation of the European market. The...

SCOPE 1.- Use of the adverse event reporting terminology This document provides the IMDRF terms, definitions and IMDRF alpha-numerical codes to be used for Adverse Event (AE) reporting concerning medical devices and in vitro diagnostics both pre and post market as...

Mais uma edição da formação sobre as  GMP para Canábis , uma  formação com todos os pontos principais das GMP, interativa e com  casos práticos que apoiam a aplicação de conhecimentos técnicos teóricos e dos conceitos das boas práticas, conduzida pelo reconhecido...

No dia 15 de março, decorreu mais uma edição da formação exclusiva da Formiventos sobre  PROMOTIONAL REVIEW COMPLIANCE & BEST PRACTICES, conduzida pela reconhecida especialista Dra Raquel Miguéis, Regulatory Affairs Senior Officer, da OWL PHARMA CONSULTING Nesta...

The Rules Governing Medicinal Products in the European Union Volume 4 EU Guidelines for Good Manufacturing Practice for Medicinal Products for Human and Veterinary Use   The final version of Annex 21 to the EU-GMP Guidelines ("Importation of medicinal products")...

PUBLISHED BY EMA News 03/03/2022 EMA’s PRIority Medicines (PRIME) scheme has had a positive impact on the authorisation of new medicines that address patients’ unmet medical needs. The time to marketing authorisation was reduced for medicines that benefitted from...

News 01/03/2022 The regulation reinforcing EMA’s role in crisis preparedness and management of medicinal products and medical devices becomes applicable as of today, 1 March 2022. It puts some of the structures and processes established by EMA during the COVID-19...