NOTICIAS

For the purposes of the Framework, DHTs are systems that use computing platforms, connectivity, software, and/or sensors for health care and related uses. They include technologies intended for use as a medical product, in a medical product, or as an adjunct to other...

PUBLISHED BY EMA News 22/03/2023 EMA has published a reportsummarising the mid-term achievements of its Regulatory Science Strategy (RSS) to 2025. The report provides an overview of the main deliverables achieved between March 2020 and December 2022 across the human...

  Regulation (EU) 2023/607 of the European Parliament and of the Council of 15 March 2023 amending Regulations (EU) 2017/745 and (EU) 2017/746 has been published today 20th Martch in the Official Journal of the EU and therefore entered into force today....

  Findou a 2ª edição da formação sobre a Gestão de Risco no âmbito das Boas Práticas de Distribuição, bajo o lema "Como aplicar a Gestão de Risco passo a passo: Análise detalhado dos processos de identificação, avaliação , controlo , revisão  e documentação...

    EVALUATION GUIDE FOR GMP REGULATORY COMPLIANCE PROGRAMME Audit Checklist (Revision 3 including API and common with Canada and PIC/S)   ANNEX TO THE EVALUATION GUIDE FOR GMP REGULATORY COMPLIANCE PROGRAMME– AUDIT CHECKLIST IMPLEMENTATION OF EU...

The Medical Device Coordination Group (MDCG) has published the MDCG 2023-3 guide, which aims to clarify important terms and concepts described in Section 2 of Chapter VII of the Regulation (EU) 2017/745 on medical devices (MDR). The guide, written for competent...

As FDA considers the application of its risk-based regulatory framework to the use of AI technologies in drug manufacturing, the Agency has identified in this discussion paper areas for which public feedback would be valuable. CDER scientific and policy experts...

The scope of this guideline is computerised systems, (including instruments, software and 'as a service') used in the creation/capture of electronic clinical data and to the control of other processes with the potential to affect participant protection and reliability...

No passado 9 de março  teve lugar em Lisboa , uma nova edição da formação  PROMOTIONAL REVIEW de DISPOSITIVOS MÉDICOS : Rotulagem, Packaging e Publicidade bajo o lema : " Optimize a sua estratégia de Rotulagem, packaging e publicidade e garanta a conformidade com as...

  The EU Council has adopted proposed changes to the EU Medical Device Regulation that will see transition deadlines extended for legacy devices. The measure had already been approved by the European Commission on 6 January. With the looming MDR transition...

    MHRA Medicines and Healthcare products Regulatory Agency Device Registrations - Reference Guide

The transformation to a digital economy and society is changing the economic reality of the single market. New emerging technologies (e.g. cleaning robots and medical health apps) already benefit our society and economy, but also present potential risks. As products...

DIGITAL HEALTH TRANSFORMATION: YEARS IN THE MAKING Citizens throughout Europe today take for granted the digital technologies that allow them to communicate with their peers anytime, anywhere, or to manage bookings for transportation, accommodation and leisure...

PUBLISHED BY News 27/02/2023 EMA has launched a pilot to give scientific advice on the intended clinical development strategy and proposals for clinical investigation for certain high-risk medical devices (all class III devices and class IIb active devices intended to...

Published by  Infarmed.pt   No âmbito da iniciativa Accelerating Clinical Trials in the EU (ACT EU) que visa promover a realização de ensaios clínicos na União Europeia que tem o suporte dos Chefes das Agências Nacionais de Medicamentos (Heads of Medicines...

Published www.medtecheurope.org The “Clinical Evidence Requirements under EU In Vitro Diagnostics Regulation” (First Edition May 2020, Second Edition November 2021, Third Edition February 2023) is a collection of questions and answers designed to help manufacturers...

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...

Nos dias  15 e 16 de fevereiro de 2023, decorreu mais uma edição da formação sobre as BOAS PRÁTICAS DE DISTRIBUIÇÃO DE MEDICAMENTOS , promovido pela Formiventos , e conduzido pela reconhecida especialista Dra Sónia Rei , Diretora Técnica da Hikma Farmacêutica...

FDA plays a critical role in protecting the United States from chemical, biological, radiological, nuclear, and emerging infectious disease threats. FDA ensures that medical countermeasures (MCMs)—including drugs, vaccines and diagnostic tests—to counter these threats...

  Transitional provisions for certain medical devices and in vitro diagnostic medical devices Today, the EU Parliament has voted the proposal of EU Commission about the extension period of MDR&IVDR. You can find all details through all languages here...

This is a quick guide on the main rules and procedures of the Clinical Trials Regulation (EU) No 536/2014 (CTR) [1] for sponsors who wish to conduct clinical trials (national and multinational) in the European Union (EU) / European Economic Area (EEA) or have ongoing...

A Associação Portuguesa das Empresas de Dispositivos Médicos (APORMED) acaba de publicar a nova versão do Código de Boas Práticas Comerciais no setor dos dispositivos médicos. A atualização do documento surge no âmbito da revisão do Código de Ética Europeu pela...

  Scope of these Q&A These Q&A aim at clarifying regulatory requirements to obtain a marketing authorisation for medicinal products in the EU (Q1) and at explaining the work of Committee on Herbal Medicinal Products (HMPC) regarding EU herbal monographs...

  This document aims to clarify important terms and concepts that are outlined in Section 2 of Chapter VII of the Regulation (EU) 2017/745 on medical devices (MDR). Establishing a common understanding of these terms and concepts is necessary for an effective and...

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...

Publication date 13 January 2023 Author   Directorate-General for Health and Food Safety   download : Update - Coverage of designation codes by MDR/IVDR notified bodies - January 2023      

No dia 9 de fevereiro decorreu mais edição da formação  CTD MODULO 3   conduzida pelo especialista  Pedro Fins Pereira, Regulatory Affairs Officer. , VIATRIS A formação ofereceu uma revisão exaustiva de todos os pontos críticos a considerar para  garantir o...

INFARMED, I.P. coordena a comunicação do projeto para os próximos três anos AIFA lidera a Joint Action de três anos O lançamento oficial do CHESSMEN, a Joint Action para mitigar a escassez de medicamentos, teve lugar em Roma O lançamento da Joint Action CHESSMEN –...

Publishe by EMA News 02/02/2023 As of today, 2 February 2023, EMA’s additional responsibilities regarding the monitoring and mitigation of shortages of critical medical devices during public health emergencies will apply. The new provisions are the last remaining part...

No dia 2 de fevereiro, decorreu mais uma edição da formação exclusiva da Formiventos sobre ENSAIOS CLÍNICOS 2023 :Uma revisão completa da regulamentação aplicável à investigação clínica com Medicamentos e Dispositivos Médicos Uma Sessão avançada de aprofundamento para...

Publicado no site INFARMED 01 fev 2023   Foi publicado, no dia 30 de janeiro, um guia rápido dirigido a Promotores de ensaios clínicos. Este guia reúne os principais aspetos, regras e procedimentos a seguir pelos Promotores que pretendem submeter e realizar...

This guidance outlines FDA’s current thinking on several topics relevant to clinical research related to the development of human drugs containing cannabis or cannabis-derived compounds. As defined in section 201(g) of the Federal Food, Drug, and Cosmetic Act...

The new ”NIS2” entered into force earlier this month with the aim to improve cybersecurity across sectors in the EU, in which medical device and IVD manufacturers are listed as a critical sector (Annex II, §5b).   DIRECTIVE (EU) 2022/2555 OF THE EUROPEAN...

  The EU Directives and the EU Guide to GMP define some detailed requirements to be met by the Qualified Person (QP). These requirements have been extracted from the relevant documents and are summarized in the Good Practice Guide "Code of Practice for QPs"....

The pandemic that changed everything The COVID-19 pandemic permanently changed global health care - from accelerating the adoption of new technology and care delivery models to increasing the focus on sustainability and resiliency.   COVID-19 has had a profound...

  The Medical Device Coordination Group (MDCG) has published the guidance MDCG 2023-1 which aims to support a harmonised application of Article 5(5) of Regulations (EU) 2017/745 (MDR) and (EU) 2017/746 (IVDR). This document is written for healthcare professionals...

Published by EMA News 31/10/2013 Amendments of the European Union (EU) pharmacovigilance legislation that were adopted in October 2012 came into force on Monday 28 October 2013. These changes, which cover various aspects of the legislation, aim to further strengthen...

   INTERNATIONAL COUNCIL FOR HARMONISATION OF TECHNICAL REQUIREMENTS FOR PHARMACEUTICALS FOR HUMAN USE ICH HARMONISED GUIDELINE QUALITY RISK MANAGEMENT Q9(R1) Final version Adopted on 18 January 2023   The ICH Q9(R1) Guideline reached Step 4 of the ICH...

O RA tem de ser um sócio estratégico nas organizações, como peça chave nas equipas de trabalho trasnversais Nos últimos anos a Indústria Farmacêutica está a experimentar uma forte e intensa transformação; os  novos modelos de negócio,  a transformação digital, a...

Press Release Published by infarmet.pt   Real4Reg – a new European research project on real world data Regulatory and health technology assessment (HTA) agencies, academic institutions and patient organisations from six EU countries will improve the use of...

  Big Data Steering Group (BDSG) 2022 report is now available.   In the document below, check out the key activities and achievements last year, which include:   ✅The appointment and establishment of the DARWIN EU ® coordination centre;  ...

Summary MDR codes coverage  More than 80% of codes are covered by more than 20/36 NBs  Just 5 codes are covered by less than 1/3 NBs: ─ MDA 0102:Active implantable devices delivering drugs or other substances ─ MDA 0104: Active implantable devices utilising...

Unprecedented disruptions caused by the COVID-19 pandemic, followed by social, economic, geopolitical and environmental challenges, continue to place complex and interconnected threats on health and healthcare systems. But the past few years have also allowed for...

The present study surveys the ongoing standardisation activities on AI carried out by ESOs (European Standards Organizations) and international Standards Development Organizations (SDOs). In the present study we investigate the alignment between AI related standards...

Publication date 10 January 2023 Author  Directorate-General for Health and Food Safety   Medical devices can be manufactured and used within EU health institutions (in-house devices), on a non-industrial scale, to address the specific needs of target patient...

  Publication date 9 January 2023 Author    Directorate-General for Health and Food Safety   IMPLEMENTATION ROLLING PLAN 2023-2024 REGULATION (EU) 2021/2282 ON HEALTH TECHNOLOGY ASSESSMENT This rolling plan contains a list of key activities that the...

Today, the Commission adopted a proposal to give more time to certify medical devices to mitigate the risk of shortages. The proposal introduces a longer transition period to adapt to new rules, as foreseen under the Medical Devices Regulation. The new deadlines...

    Reasons for and objectives of the proposal Regulation (EU) 2017/745 (MDR) and Regulation (EU) 2017/746 (IVDR) of the European Parliament and of the Council establish a reinforced regulatory framework for medical devices and in vitro diagnostic medical...

This guidance provides recommendations for the format and content of a risk evaluation and mitigation strategy (REMS) document for a prescription drug product, including a biological drug product. A REMS document, which is part of a REMS that is required by FDA,...

Objective This guideline is intended to provide recommendations on conducting bioequivalence (BE) studies during both development and post approval phases for orally administered immediate-release (IR)  solid oral dosage forms designed to deliver drugs to the systemic...