NOTICIAS
New MDCG Jan. 2024 Post-Market Surveillance and Vigilance (PMSV).
Five new mdcg files read the full thread. 1. MDCG 2024-1 Guidance on the vigilance system for CE-marked devices Source: https://lnkd.in/gKC3KPaD 2. MDCG 2024-1-1 DSVG 01 on Cardiac ablation Source: https://lnkd.in/gKM9RuCH 3. MDCG 2024-1-2 Guidance on the...
Boas Práticas de Fabrico Nível avançado: ” Muito interessante e proveitoso “
Decorreu no dia 25 de janeiro a formação exclusiva da Formiventos sobre as Boas Práticas de Fabrico :Nível avançado; uma sessão de aprofundamento, actualização e revisão das Novidades GMP, conduzida pela reconhecida especialista, Dra Teresa Cruz da MTA Pharma...
Impact of the EU’s General Pharmaceutical Legislation on Europe’s Innovation Ecosystem and Biotechnology Companies
Today EuropaBio - the European Association for Bioindustries and Charles River Associates launch the new study “Impact of the EU’s General Pharmaceutical Legislation on Europe’s Innovation Ecosystem and Biotechnology Companies”! This new study highlights the...
EU MDR/IVDR News!! (Eudamed and IVDR Extension)
Today (23-Jan) the European Commission has published a Proposal for "Regulation of the European Parliament and of the Council amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards a gradual roll-out of Eudamed, information obligation in case of interruption...
Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL LAYING DOWN HARMONISED RULES ON ARTIFICIAL INTELLIGENCE
Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL LAYING DOWN HARMONISED RULES ON ARTIFICIAL INTELLIGENCE (ARTIFICIAL INTELLIGENCE ACT) AND AMENDING CERTAIN UNION LEGISLATIVE ACTS 2021/0106(COD) DRAFT Final draft as updated on...
Major update of the SME user guide
The revised user guide offers comprehensive information on the EU legislative framework for medicines, outlining requirements for the development and authorisation of medicines for human and veterinary use. It follows the chronological stages of medicine development,...
US Healthcare Outlook: Strategic Insights into Profit Pools, Value-Based Care, and Technological Advances
The US healthcare industry faces demanding conditions in 2023, including recessionary pressure, continuing high inflation rates, labor shortages, and endemic COVID-19. But players are not standing still. We expect accelerated improvement efforts to help the industry...
WHO releases AI ethics and governance guidance for large multi-modal models
The World Health Organization (WHO) is releasing new guidance on the ethics and governance of large multi-modal models (LMMs) – a type of fast growing generative artificial intelligence (AI) technology with applications across health care. The guidance outlines over...
Infarmed lança livro sobre a história dos Dispositivos Médicos ao longo dos últimos 30 anos
No evento comemorativo do 31º aniversário do Infarmed foi apresentado o novo livro "30 Anos de Dispositivos Médicos no Infarmed" que reflete a história dos Dispositivos Médicos ao longo dos últimos 30 anos e revela as principais mudanças a operar no futuro nesta área....
Overview of language requirements for manufacturers of medical devices
Details Publication date 17 January 2024 Author Directorate-General for Health and Food Safety Description The Commission and Member States have created MDR and IVDR tables. These tables aim to help manufacturers of medical devices and in vitro diagnostic medical...
Human medicines: highlights of 2023
In 2023, EMA recommended 77 medicines for marketing authorisation. Of these, 39 had a new active substance which had never been authorised in the European Union (EU) before. Among these are a number of medicines that stand out due to their contribution to address...
Roadmap towards the future regulatory framework for medical devices
MHRA UK has published a roadmap for the future regulatory framework for medical devices. The roadmap outlines timelines for delivering new measures to support safe access to medical technology, including AI and diagnostics. The implementation of this future regime is...
Study supporting the monitoring of availability of medical devices on the EU market
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...
Big Data Workplan 2023-2025
The vision on Big Data is a strengthened regulatory system that can efficiently integrate data analysis into its assessment processes to improve decision making. Knowing when and how to have confidence in novel technologies and the evidence generated from Big Data...
Digital Health Technologies for Remote Data Acquisition in Clinical Investigations
This guidance provides recommendations on the use of digital health technologies (DHTs) to acquire data remotely from participants in clinical investigations that evaluate medical products. DHTs for remote data acquisition in clinical investigations can include...
Publicado relatório intercalar da Estratégia da Rede Europeia de Agências de Medicamentos 2020-2025
A Agência Europeia de Medicamentos (EMA na sigla em inglês) e os Chefes das Agências de Medicamentos (HMA na sigla em inglês) apresentam resultados intermédios da Estratégia 2025: o relatório intercalar da Estratégia da Rede Europeia de Agências de Medicamentos...
The clock is ticking – MedTech Europe’s recommendations ahead of May 2025 deadline for Class D IVDs
Class D IVDs are critical for public health. They mainly fall into two categories: a) those related to blood, cells, tissues or organ screening, and b) those related to management of life-threatening infectious diseases. Under the In vitro Diagnostic Medical Devices...
FDA Publishes Structured Product Labeling (SPL) Implementation Guide with Validation Procedures for Cosmetic Product Facility Registrations and Product Listings
What's New December 15, 2023 The FDA published an updated Structured Product Labeling (SPL) Implementation Guide with Validation Procedures on December 14, 2023. The guide includes updates to the cosmetics product facility registrations and product listings that are...
Decreto-Lei n.º 128/2023 de 26 de dezembro . Altera os regimes jurídicos dos medicamentos de uso humano e das farmácias de oficina
Decreto-Lei n.º 128/2023, de 26 de dezembro Publicação: Diário da República n.º 247/2023, Série I de 2023-12-26, páginas 82 - 85 Emissor: Presidência do Conselho de Ministros Entidade Proponente: Saúde Data de Publicação: 2023-12-26 SUMÁRIO Altera os regimes jurídicos...
EMA–FDA joint Q&As on Quality and GMP aspects of PRIME/Breakthrough therapy applications
EMA’s PRIority MEdicines (PRIME) scheme and FDA’s breakthrough therapy (BT) designation program are designed to help speed development of innovative products which address unmet medical needs. For products included in these expedited development programs, the...
MDCG 2019-07 Rev.1 Guidance on Article 15 of the medical device regulation (MDR) and in vitro diagnostic device regulation (IVDR) on a ‘person responsible for regulatory compliance’ (PRRC)”
This document presents questions and answers on requirements related to importers and distributors under Regulation (EU) 2017/745 on medical devices (MDR) and Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR). The term ‘devices’ will be understood...
Draft Guidance “Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices”.
FDA is issuing this draft guidance to clarify how FDA evaluates real-world data (RWD) to determine whether they are of sufficient quality for generating real world evidence (RWE) that can be used in FDA regulatory decision-making for medical devices. This draft...
Master Protocols for Drug and Biological Product Development
This guidance document provides recommendations on the design and analysis of trials conducted under a master protocol as well as guidance on the submission of documentation to support regulatory review The primary focus of this guidance is on randomized umbrella and...
Guidance on exemptions from the requirement to perform clinical investigations pursuant to Article 61(4)-(6) MDR and on sufficient levels of access’ to data needed to justify claims of equivalence
The MDCG has released a guidance document regarding exemptions from the requirement to perform clinical investigations pursuant to Article 61(4)-(6) MDR. This guidance is intended to clarify the exemptions from the requirement to perform clinical investigations, and...
Artificial Intelligence workplan to guide use of AI in medicines regulation
EMA and the Heads of Medicines Agencies (HMAs) have published an Artificial Intelligence (AI) workplan to 2028, setting out a collaborative and coordinated strategy to maximise the benefits of AI to stakeholders while managing the risks. The workplan will help...
Study Data Technical Conformance Guide – Technical Specifications Document
This technical specifications document represents the Food and Drug Administration's (FDA's) current thinking on this topic. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. You can use an...
Advanced Manufacturing Technologies Designation Program
Advanced manufacturing is a term for an innovative pharmaceutical manufacturing technology or approach that has the potential to improve the reliability and robustness of the manufacturing process and supply chain and increase timely access to quality medicines for...
Questions and Answers about the raw data proof-ofconcept pilot for industry
The PoC pilot is performed to investigate the benefits of having access to raw data from regulatory submissions to support the scientific assessment of medicinal products and to identify the associated operational, resource and technological needs. Learnings from the...
MDCG 2023-6 – Guidance on demonstration of equivalence for Annex XVI products – A guide for manufacturers and notified bodies –
This MDCG guidance covers the demonstration of equivalence, based on data pertaining to an already existing device, for the purpose of CE-marking under the MDR and is applicable to products without an intended medical purpose listed in the Annex XVI of MDR and covered...
MDCG 2023-6 Guidance on demonstration of equivalence for Annex XVI products
EU MDR News! (Product Without an Intended Medical Purpose (Annex XVI)) Today (14/12) the Medical Device Coordination Group (MDCG) has published two new documents regarding Product Without an Intended Medical Purpose (Annex XVI). "MDCG 2023-5 Guidance on qualification...
Ensaios clínicos de transição, prazo, orientações disponíveis: procedimento acelerado para a transição de ensaios para o sistema CTIS
13 dez 2023 Publicado no site INFARMED O INFARMED, I.P. recorda que, até 30 de janeiro de 2025, todos os ensaios aprovados ao abrigo da Diretiva dos ensaios clínicos (Diretiva 2001/20/CE) que ainda estejam em curso terão de ser transferidos para o CTIS (Sistema...
First version of the Union list of critical medicines agreed to help avoid potential shortages in the EU
The European Commission (EC), the Heads of Medicines Agencies (HMA) and EMA have published the first version of the Union list of critical medicines. It contains more than 200 active substances of medicines for human use considered critical for healthcare systems...
Just published: EMA’s Data Quality Framework sets the standard for health data
Regulatory decision-making is only as strong as the data that underpin it. Technological development may allow us to generate all sorts of data from e-records to health databases, from apps to wearable devices. But how do we make sure this information is of high...
Update – MDCG 2021-6 – Rev.1 – Regulation (EU) 2017/745 – Questions & Answers regarding clinical investigation
This document is intended for sponsors of clinical investigations of devices conducted within the scope of the Regulation (EU) 2017/745 (MDR). This document may be supplemented in due course with further questions and answers. Throughout this document the term...
GESTÃO da DISPONIBILIDADE de MEDICAMENTOS : “Formação muito enriquecedora, com muita interação e envolvimento dos formandos
Realizou-se no dia 30 de novembro a primeira edição do workshop exclusivo da Formiventos sobre a GESTÃO da DISPONIBILIDADE de MEDICAMENTOS, conduzido por Helena Ponte, Unidade de Projetos Interinstitucionais e para o Sistema de Saúde da INFARMED Foi uma sessão...
Novos pedidos de AIM 2023 : “Formador excelente. Formação muito prática e útil.”
Nos dias 5 e 6 de dezembro decorreu a formação sobre os Novos pedidos de AIM : Uma combinação de teoria e exercícios práticos, para adquirir os conhecimentos cruciais para gerir com sucesso a tramitação completa do seus Novos pedidos de AIM O formador, Dr Selmo...
The EU health policy Pharmaceutical Reform . Awareness session for SMEs EMA
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EU Implementation Guide (Vet EU IG) on veterinary medicines product data in the Union Product Database
This document provides detailed guidance on the data elements and associated business rules for the submission of information on medicinal products authorised for veterinary use into the Union Product Database (UPD), as required in Regulation (EU) 2019/6 and...
BOAS PRÁTICAS CLÍNICAS ICH GCP E6 (R3) : “Excelência na exposição da informação”
No 30 de novembro decorreu a formação sobre as BOAS PRÁTICAS CLÍNICAS : ICH GCP E6 (R3)conduzida pela reconhecida especialista Dra Maria Alexandra Ribeiro, Presidente da CEIC A Formiventos apresentou um curso específico de actualização com o objetivo de efectuar uma...
PROMOTIONAL REVIEW COMPLIANCE & BEST PRACTICES: “Formação muito bem organizada, estruturada, e com casos práticos atuais.”
No passado dia 29 de novembro decorreu mais uma nova edição da formação sobre PROMOTIONAL REVIEW COMPLIANCE & BEST PRACTICES conduzido por Sónia Ferreira, Technical Director, RA Manager/ LRPPV, Quality Manager da GUERBET. A. MARTINS & FERNANDES Uma sessão...
MDCG Position Paper : Notice to manufacturers and notified bodies to ensure timely compliance with MDR and IVDR requirements
With the adoption of Regulations (EU) 2017/745 (MDR) and 2017/746 (IVDR), the regulatory framework for medical devices and in vitro diagnostic medical devices (IVD) has significantly changed. The main objectives of these two Regulations are to establish a robust,...
EFPIA White Paper on Climate Change
The research driven pharmaceutical industry, represented by EFPIA, strives to improve human health and wellbeing. It is scientifically proven that climate change will adversely impact human health . Therefore, understanding the relationship between people, health and...
Falsification of medical devices – Results of European survey
The falsification of medical devices is a serious international matter of concern, but little data is available, making it difficult to assess the current state of affairs. To help bridge this gap, the Committee of Experts on Minimising Public Health Risks Posed by...
CONTROLO DE ALTERAÇÕES: “Evento super interessante , onde o conhecimento teórico e prático são postos a disposição dos participantes”
No dia 29 de novembro , decorreu em Lisboa a 5ª edição da formação sobre o CONTROLO DE ALTERAÇÕES, conduzido por Sara Cunha , CHC & GEM Quality Business Partner, da Sanofi A Formiventos apresentou esta formação exclusiva para os profissionais da Indústria...
Q&A on the protection of Commercially Confidential Information and Personal Data while using CTIS
This Q&A document has been created to provide preliminary guidance to CTIS users on how to protect personal data and commercially confidential information (CCI) in CTIS, the EU database established in accordance with the requirements of Regulation (EU) No 536/2014...
Qualificação de Fornecedores : ” Uma exclelente formação com conhecimentos actualizados e muito interessante . “
No passado dia 22 de novembro decorreu mais uma nova edição da formação sobre Qualificação de Fornecedores ,Clientes e Entidades Subcontratadas , conduzida por Teresa Cruz , da MTA Pharma Nesta formação foram revistos todos os passos do processo da qualificação :...
IRIS guide for applicants (How to create and submit IRIS applications, for industry and individual applicants)
This guide has been produced to show applicants how to use the IRISplatform to prepare and submit an #application and/or data for a #scientificprocedure (orphan designation application, scientific advice,ITF briefing meeting requests, PRIME, marketing status reports,...
Personal health data: better portability and safe sharing
Better healthcare with portability rights The law would give patients the right to access their personal health data across the EU’s different healthcare systems (so-called primary use), and allow health professionals to access data on their patients. Access would...
Application of ISO/IEC 17021-1 in the Field of Medical Device Quality Management Systems (ISO 13485)
ISO/IEC 17021-1 is an International Standard that sets out the general requirements for bodies operating audit and certification of organizations’ management systems. If such bodies are to be accredited as complying with ISO/IEC 17021-1 with the objective of auditing...
BOAS PRÁTICAS DE DISTRIBUIÇÃO DE MEDICAMENTOS “ Excelente formação , muito esclarecedora e com a grande vantagem de discussão de casos práticos.
Nos dias 22 e 23 de novembro teve lugar a edição número 20 da formação sobre as BOAS PRÁTICAS de DISTRIBUIÇÃO de medicamentos de uso humano e de substâncias ativas; uma formação dinâmica, super interessante donde são abordados os temas de forma prática e concisa e...
New Cybersecurity Requirements for Medical Devices in the EU: The Forthcoming European Health Data Space, Data Act, and Artificial Intelligence Act
Much has been written on cybersecurity generally and on medical device cybersecurity more specifically; however, the latter is a matter of relatively recent regulation in the EU. In some of our previous work,2 we set out the existing legal framework on cybersecurity,...