NOTICIAS

New position paper released by Team-NB related to 'Notified bodies’ paper on the application of hybrid audits to quality management system assessments under MDR/IVDR'. Hybrid audits in the context of legislative requirements Notified bodies are required to undertake...

Published by KPMG   Stake your claim in the medical device value chain of the future and avoid the commodity trap. While the outlook for medical device companies appears positive, unsustainable healthcare costs and new competitive forces threaten to alter the...

  This guidance provides the further standards for the submission of premarket notification (510(k)) submissions by electronic format, a timetable for establishment of these standards, and criteria for waivers of and exemptions from the requirements to meet a...

O Anexo 1 do Guia das Boas Práticas de Fabrico (EudraLex, Volume 4, Parte I), referente a orientações sobre o fabrico de medicamentos estéreis, foi revisto por forma a englobar alterações relacionadas com as condições ambientais no âmbito do fabrico de medicamentos...

EU IVDR News ( Article 110) MDCG 2022-15 Guidance on appropriate surveillance regarding the transitional provisions under Article 110 of the IVDR with regard to devices covered by certificates according to the IVDD This guidance document outlines the activities to be...

FDA is issuing this draft guidance to provide recommendations on computer software assurance  for computers and automated data processing systems used as part of medical device production  or the quality system.   This draft guidance is intended to:  · Describe...

imdrf

Determining whether a given product falls under the definition of a medical device and the application of the classification rules fall within the competence of the authorities of the Member States where the product is on the market. However, when different...

This document1 aims to provide guidance to the authorities responsible for notified bodies (hereafter, the Designating Authorities) and joint assessment teams (JATs) when conducting: i. assessments of conformity assessments bodies (CABs) that apply for designation as...

The report is the result of four years of work with patient group leaders, academics, industry experts, regulators and other stakeholders, and EMA is pleased to have been involved. Patients are at the centre of modern healthcare and their engagement is critical to...

  Background note on the relationship between MDCG 2020-6 and MEDDEV 2.7/1 rev. 4 on clinical evaluation MDCG 2020-6 document Regulation (EU) 2017/745: Clinical evidence needed for medical devices previously CE marked under Directives 93/42/EEC or 90/385/EEC - A...

PUBLICADO NO SITE INFARMED 01 set 2022 Os Regulamentos dos dispositivos médicos, que entraram em vigor a 26 de Maio de 2021, representam uma atualização importante às diretivas até então existentes e pretendem fortalecer e melhorar o sistema europeu, garantindo maior...

  Following a warning from health ministers, the EU executive agreed on a list of actions to ease the transition into the new framework for medical devices as its sluggish implementation threatens a shortage in Europe. The list was approved by the Medical Device...

PUBLISHED BY EMA News 30/08/2022 The European Commission (EC), the Heads of Medicines Agencies (HMA) and the European Medicines Agency (EMA) have published the  2022-2026 workplan of the initiative Accelerating Clinical Trials in the EU (ACT EU). ACT EU, launched in...

After many years, the final revision to Annex 1 "Manufacture of Sterile Medicinal Products," under the The Rules Governing Medicinal Products in the European Union Volume 4 EU Guidelines for Good Manufacturing Practice for Medicinal Products for Human and Veterinary...

publicado no site INFARMED  05 ago 2022   Na sequência da Deliberação N.º 76/CD/ 2022 de 29 de julho foi aprovada a versão 3.0 da Metodologia de Avaliação Farmacoterapêutica, a qual produz efeitos a 1 de novembro de 2022. Decorrente dos desafios metodológicas...

Published by EMA News 28/07/2022   The Big Data Steering Group set up by EMA and the Heads of Medicines Agencies (HMA) has published its PDF icon third workplan that sets key actions to be delivered between 2022–25. The new workplan will allow to further enhance...

PUBLISED BY EMA News 22/07/2022 EMA has endorsed a joint statement calling for international collaboration to enable the generation and use of real-world evidence for regulatory decision-making published today by the International Coalition of Medicines Regulatory...

This guidance explains FDA’s therapeutic equivalence evaluations, including the assignment of  therapeutic equivalence codes (or TE codes). As defined in 21 CFR 314.3(b), therapeutic  equivalents are:  approved drug products that FDA has determined are pharmaceutical...

The European Commission published version 20 of the Questions & Answers (Q&As) regarding the safety features for medicinal products for human use. Compared to the previous version 19, the new version contains one new Q&A. This documents sets out...

MedTech Europe Survey Report – Analysing the availability of Medical Devices in 2022 in connection to the Medical Device Regulation (MDR) implementation During the month of April 2022, MedTech Europe members participated to a survey commissioned by the Medical Device...

   Marketing authorisation holders for all authorised medicines in the EU are required to appoint a so-called industry single point of contact (i-SPOC) who can provide information directly to EMA about the supply and availability of critical...

PUBLISHED  BY EMA News 12/07/2022 EMA has launched a pilot project to assess whether the analysis of ‘raw data’ from clinical trials by regulatory authorities improves the evaluation of marketing authorisation applications (MAAs) for new medicines as well as...

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...