NOTICIAS

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...

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...

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...

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...

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...

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...

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...

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...

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 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’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...

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...

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...

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...

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...

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...

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 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...

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...

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...

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...

  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...

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...

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...

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...

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...

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...

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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...

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...

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...

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,...

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...

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...

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...

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...

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 :...

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,...

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...

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...

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...

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,...

De acordo com os dados da EMA, mais de 40% das submissões requerem ser revistas. As deficiências mais comuns são as relativas ao preenchimento dos formulários, a deficiências na classificação das alterações e à falta de documentação de suporte (não justificação das...

Realizou-se no dia 21  de novembro a segunda  edição do workshop exclusivo da Formiventos sobre  Aprovação, Formação e Revisão anual de PREÇOS de MEDICAMENTOS  conduzido pela excelente formadora Dra Jalmira Mulchande, Senior Consultant da PHARMAISSUES Este programa...

The revised Annex 1 of the EU GMP Guideline, came into force on August 25th, 2023. The revised Annex 1 of the PIC/S GMP Guideline (PE 009) on the manufacture of sterile medicinal products was adopted by the PIC/S Committee on September 9, 2022 and came into force on...

MedTech Europe and its members fully support the objectives of the medical technology regulations IVDR and MDR to establish a “robust, transparent, predictable and sustainable regulatory framework for [in vitro diagnostic] medical devices which ensures a high level of...

The primary purpose of this IMDRF guidance is to recommend a harmonized approach for the application of existing regulatory pathways to medical devices that are intended for a particular individual, and to identify special considerations for the regulation of each...

Questions and answers are being updated continuously and will be marked by “NEW” or “Rev.” with the relevant date upon publication. This guidance document addresses a number of questions which marketing authorisation holders (MAHs) may have on post-authorisation...

This guidance is intended to assist owners or operators of cosmetic product facilities that are subject to the requirements related to facility registration and responsible persons that are subject to the requirements related to cosmetic product listing under the...

News 08/11/2023 The Heads of Medicines Agencies (HMA), the European Commission (EC) and EMA have published for the first time electronic product information (ePI) for selected human medicines harmonised across the European Union (EU). The product information of a...

Apresentamos-lhe a edição número 2 da formação sobre "Aprovação, Formação e Revisão anual de PREÇOS de MEDICAMENTOS" que vai decorrer no próximo dia 21 de novembro em Lisboa . Um guia completo para o desenvolvimento da estratégia de pedido de preço de medicamentos, e...