NOTICIAS

The new monograph on Cannabis flower (3028) was adopted at the 176th session of the European Pharmacopoeia (Ph. Eur.) Commission held on 20 and 21 June 2023. Given the exceptionally high interest from stakeholders in having access to the new text as soon as possible,...

This guidance is intended to assist sponsors of clinical trials in determining when a data monitoring committee (DMC) (also known as a data and safety monitoring board (DSMB), a data and safety monitoring committee (DSMC), or an independent data monitoring committee...

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled “Conducting Remote Regulatory Assessments--Question and Answers.” FDA is issuing the draft guidance to describe the Agency’s current thinking...

  Version 5, 7 February 2024 -- This glossary combines the terms and definitions included in the guidelines of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). It was compiled by CIOMS from the...

O dia 31 de janeiro de 2024, marca os dois anos de entrada em aplicação do Regulamento Europeu de Ensaios Clínicos (CTR), e do lançamento do Sistema de Informação de Ensaios Clínicos (CTIS). Assinala-se o aproximar do fim do período de transição para CTR/CTIS dos...

The medtech industry posted an uneven year in 2023. Among the reasons for celebration were expectation-beating revenue growth, a record number of novel-product approvals, and a spate of divestitures that helped companies refocus on their core capabilities.   On...

  NB NEWS: The results of the 6th Notified Bodies Survey on certifications and applications (MDR/IVDR) have just been published 5 Febuary 2024.

The European Medical Device Nomenclature (EMDN), as established by Article 26 of Regulation (EU) 2017/745 – Medical Device Regulation (MDR) and Article 23 of Regulation (EU) 2017/746 - In Vitro Diagnostic medical devices Regulation (IVDR), will be annually reviewed...

A large release of the Medical Device Coordination Group (MDCG) Guidance on Vigilance has been published to the European Commission website: MDCG 2024-1, MDCG 2024-1-1, MDCG 2024-1-2, MDCG 2024-1-3, and MDCG 2024-1-4. Each guidance falls into the “Device Specific...

From 1 January 2024, the EC Decision Reliance Procedure (ECDRP) will be replaced by the new International Recognition procedure (IRP). The Mutual Recognition/Decentralised Reliance Procedure (MRDCRP) will be incorporated under the umbrella of IRP. ECDRP and MRDCRP...

Consultation open Medical Device Software: Considerations for Device and Risk Characterization Start date Friday, 2 February 2024 Closing date Thursday, 2 May 2024   A Proposed Document by the International Medical Device Regulators Forum (IMDRF), Software as a...

A new perspective on how technology, transformation efforts, and other changes have affected payers, health systems, healthcare services and technology, and pharmacy services   The acute strain from labor shortages, inflation, and endemic COVID-19 on the...

The World Health Organization (WHO) developed the Quality Assurance of Pharmaceuticals Compendium, Volume 2, to ensure the quality, safety and effectiveness of medicines, focusing on good manufacturing practices (GMP) and related guidelines. This summary provides an...

The FDA issued the Quality Management System Regulation (QMSR) Final Rule, which amends the device current good manufacturing practice (CGMP) requirements of the Quality System (QS) regulation (21 CFR Part 820), incorporating the international standard specific for...

This IAF Medical Device Nomenclature document (IAF MDN) is an informative document that was developed for the support of IAF MD8 and MD9. It provides long established medical device names and classifications, where risk classifications do not exist in the Global...

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 devices, particularly small and medium-sized ones, understand the language requirements for the information and...

Update: January 31, 2024 The FDA issued the Quality Management System Regulation (QMSR) Final Rule to amend the device current good manufacturing practice (CGMP) requirements of the Quality System (QS) regulation (21 CFR Part 820), incorporating by reference the...

  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...

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...

  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...

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 (ARTIFICIAL INTELLIGENCE ACT) AND AMENDING CERTAIN UNION LEGISLATIVE ACTS 2021/0106(COD) DRAFT Final draft as updated on...

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,...

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...

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...

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....

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...