NOTICIAS

This reflection paper is intended to reflect the current thinking of EMA's Committee for Medicinal Products for Human Use (CHMP) on single-arm trials (SATs) that are submitted as pivotal evidence for establishing efficacy in a marketing authorisation application....

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. The...

This guidance is intended to explain the practice of Articles 60 to 68 of Regulation (EU) 2019/6 of the European Parliament and of the Council of 11 December 2018 on #veterinarymedicinalproducts, laying down rules for the placing on the market, manufacturing, import,...

Today, the Commission is proposing to revise the EU's pharmaceutical legislation - the largest reform in over 20 years - to make it more agile, flexible, and adapted to the needs of citizens and businesses across the EU. The revision will make medicines more...

The Commission is proposing an ambitious revision of the EU pharmaceutical legislation to achieve the following main objectives:  Create a Single Market for medicines ensuring that all patients across the EU have timely and equitable access to safe, effective, and...

  Scope of Document This best practice guidance document has been developed by members of Team NB who have reviewed the best practice guidance documents submitted by individual Team NB notified body members, with the purpose to develop a unified approach on the...

This report addresses the following objectives of AI Watch: with the aim to study the evolution of the European market shares in robotics over the past ten years, this report i) offers a brief overview of the robotics industry; ii) reviews the scientific and...

Decorreu no passado dia 20 de abril  a formação sobre  Aprovação, Formação e Revisão anual de PREÇOS de MEDICAMENTOS, bajo o lema : " Um guia completo para o desenvolvimento da estratégia de pedido de preço de medicamentos, e para a revisão anual de preços de...

    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...

Presented to Parliament by the Secretary of State for Science, Innovation and Technology by Command of His Majesty on 29 March 2023. Command Paper Number: 815 © Crown copyright 2023     The proposed regulatory framework  Our innovative approach to...

  Fecha de publicación: 17 de abril de 2023 Los productos cosméticos forman parte de la vida cotidiana de las personas, ya que se emplean diariamente en su cuidado e higiene. Por esta razón, es esencial confiar en su seguridad y transmitir a la ciudadanía su alto...

Publicado no site infarmed : www.infarmed.pt.  17 abr 2023 Para: Requerentes e Titulares de Autorização de Introdução no Mercado (TAIM) Circular Informativa N.º 032/CD/100.20.200 Data: 14/04/2023 O INFARMED, I.P. procedeu a uma revisão das instruções aos requerentes...

Two directives laying down principles and guidelines of GMP for medicinal products were adopted by the European Commission. Directive 2003/94/EC applies to medicinal products for human use and Directive 91/412/EEC for veterinary use. Detailed guidelines in accordance...

The purpose of this IMDRF guidance is to provide harmonized recommendations for verification and validation aspects of a patient-matched medical device and a medical device production system (MDPS). The adoption of consistent, harmonized requirements for such medical...

Published date  11 April 2023 Status  Final     This document is designed to provide concrete recommendations on how to apply the TPLC to legacy devices to aid in the implementation of the framework put forward in the preceding IMDRF N60 guidance. This document is...

Sponsors of clinical investigations involving human drugs, biological products, medical devices, and combination products are required to provide oversight, including ensuring proper monitoring of the investigation. Such oversight helps to ensure adequate protection...

FDA is issuing this draft guidance to further develop a regulatory approach tailored to artificial intelligence/machine learning (AI/ML)-enabled devices to increase patients’ access to safe and effective AI/ML-enabled devices, in order to protect and promote public...

No dia 20 de março de 2023 entrou em vigor o Regulamento (UE) 2023/607 que altera os Regulamentos (UE) 2017/745 (RDM) e (UE) 2017/746 (RDIV) no que diz respeito às disposições transitórias aplicáveis a determinados dispositivos médicos e dispositivos médicos para...

  No passado 29 de março  teve lugar em Lisboa , uma nova edição da formação Qualificação de Fornecedores ,Clientes e Entidades Subcontratadas , conduzido pela reconhecida especialista Dra Teresa Cruz da MTA Pharma Nesta formação os participantes tiveram a ...

  The new UDI Helpdesk is live The European Commission has launched a new helpdesk to support implementing the requirements introduced by the new Unique Device Identification (UDI) system within the context of the new Medical Device Regulation. The EU Commission...

The amendment of the MDR and of the IVDR through Regulation (EU) 2023/607 aims to ensure a high level of public health protection, including patient safety and an avoidance of shortages of medical devices needed for the smooth functioning of healthcare services,...

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...