NOTICIAS

FDA has interpreted this substantial evidence requirement as generally requiring two adequate 44 and well-controlled clinical investigations, each convincing on its own, to establish effectiveness.  Nevertheless, as noted in the 1998 Effectiveness guidance, FDA has...

FDA is issuing this draft guidance document to introduces submitters of De Novo requests to the Center for Devices and Radiological Health and Center for Biologics Evaluation and Research to the current resources and associated content developed and made publicly...

Determining whether a given product falls under the definition of a medical device and the application of the classification rules fall within the competence of the authorities of the Member States where the product is on the market. However, when different...

Circular N.º 098/CD/100.20.200 de 22/09/2023 A Circular Informativa N.º 098/CD/100.20.200 divulga a revisão do “CTCG Best Practice Guide for sponsors of multinational clinical trials with different protocol versions approved in different Member States under the...

  This document provides FDA’s recommendations to industry regarding cybersecurity device design, labeling, and the documentation that FDA recommends be included in premarket submissions for devices with cybersecurity risk. These recommendations are intended to...

Disclaimer: this Q&A document intends to facilitate the application of the transitional provisions set out in Commission Implementing Regulation (EU) 2022/23461 , as amended by Commission Implementing Regulation (EU) 2023/11942 . This document has not been...

This newsletter from the European Commission aims to provide highlights and updates from the medical devices (MDs) and in vitro diagnostic medical devices (IVDMDs) sector. In this edition, you will find updates on the September’s session of the International Medical...

  The #GoodClinicalPractice (GCP) Inspectors Working Group has developed procedures for the coordination, preparation, conduct and reporting of GCP inspections requested by the European Medicines Agency's (#EMA) Committee for Medicinal Products for Human Use...

  This document outlines a brief overview of the main new features in EUDAMED Production v2.12 compared to the previous release    

  This guidance describes how FDA intends to apply its drug labeling authorities to certain software outputs that are disseminated by or on behalf of a drug sponsor for use with a prescription drug or a prescription drug-led, drug-device combination product...

The purpose of this document is to help Competent Authorities, Notified Bodies, as well as all Economical Operators (Manufacturers, Authorised Representatives, Importers, and System/Procedure Pack Producers) in assessing the most cost-efficient solution for their...

O presente documento visa clarificar algumas questões relacionadas com a redação da Portaria n.º 235/2023, de 27 de julho, a qual determina a possibilidade de aplicação de medidas específicas que visam garantir o acesso e a manutenção no mercado nacional de...

This guidance is intended to help applicants develop draft labeling for proposed biosimilar and interchangeable biosimilar products2 18 for submission in an application under section 351(k) of the  Public Health Service Act (PHS Act) (42 U.S.C. 262(k)) (351(k)...

The IMDRF Personalized Medical Devices (PMD) Working Group has today updated the final guidance document on 'Personalized Medical Devices - Regulatory Pathways'. This Edition 2 builds on the previous document released in 2020. This document applies to all personalized...

FDA has developed this guidance document to assist industry in preparing Premarket Applications (PMAs), Humanitarian Device Exceptions (HDEs), Investigational Device Applications (IDEs), Premarket Notifications (510(k)s), and De Novo requests for medical devices that...

  This guidance provides information on the implementation of the PostWarningLetterMeeting process for certain facilities, a program enhancement agreed upon by the Agency and industry as part of the negotiations relating to the reauthorization of the...

The 21st Century Cures Act (Cures Act), signed into law on December 13, 2016, is intended to accelerate medical product development and bring innovations faster and more efficiently to the patients who need them. Among other provisions, the Cures Act added section...

This module addresses in detail how to  hashtag#controlimpurities  in  hashtag#activesubstances  in the context of a  hashtag#CEPapplication . The presentation outlines how to build and justify an appropriate control strategy, not only for  hashtag#organic  and...

  Flowchart to assist in deciding whether or not a device is covered by the extended MDR transitional period. Publication date 23 August 2023 Author Directorate-General for Health and Food Safety The flowchart is intended to assist manufacturers and other...

This guidance is intended to assist institutional review boards (IRBs), clinical investigators, and sponsors in complying with FDA’s informed consent regulations for clinical investigations. This guidance supersedes FDA’s guidance entitled “A Guide to Informed...

This guidance provides recommendations and instructions to assist persons submitting cosmetic product facility registrations and product listings to FDA.  This guidance document explains, among other things: The statutory requirement to submit cosmetic product...

  The medical device Regulation (EU) 2017/745 (MDR) came into force in 2017 to supersede the MDD (Medical Device Directive) and AIMDD (Active Implantable Medical Device Directive). The development of this new regulation was focused on addressing perceived...

Commission Regulation (EU) 2023/1545 of 26 July 2023 amending Regulation (EC) No 1223/2009 of the European Parliament and of the Council as regards labelling of fragrance allergens in cosmetic products   THE EUROPEAN COMMISSION, Having regard to the Treaty on the...

EMA News EMA has published a draft reflection paper outlining the current thinking on the use of artificial intelligence (AI) to support the safe and effective development, regulation and use of human and veterinary medicines. This paper, which is now open for public...

Published by McKinsey Insights   The latest annual McKinsey Global Survey on the current state of AI confirms the explosive growth of generative AI (gen AI) tools. Less than a year after many of these tools debuted, one-third of our survey respondents say their...

Harvard Business Publishing: https://hbr.org/sponsored/2023/08/innovation-in-data-driven-health-care   Innovative uses of data in health care are helping solve the most challenging problems in patient health and operational efficiency. Today, many health care...

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 complementary to the IMDRF N60 guidance, and the...

  DOWNLOAD PDF Notified Bodies Survey on certifications and applications (MDR/IVDR

25 JULHO 2023. ORDEM  DOS FARMACÊUTICOS O Conselho do Colégio de Especialidade de Assuntos Regulamentares da Ordem dos Farmacêuticos (CCEAR-OF) atualizou o guia de Boas Práticas Regulamentares, cuja primeira edição foi publicada em março de 2004. Excetuando o capítulo...

This guidance describes a voluntary program for the qualification of medical device development tools (MDDTs) for use in the evaluation of devices regulated by CDRH.  Specifically, this guidance describes the framework for voluntary proposal and qualification of an...

The European Directorate for the Quality of Medicines & HealthCare (EDQM) is pleased to announce that the CEP 2.0 will be implemented on 1 September 2023. From that date onwards, new dossier applications and renewal applications will receive a CEP 2.0, whereas...

EMA has published a draft reflection paper outlining the current thinking on the use of artificial intelligence (AI) to support the safe and effective development, regulation and use of human and veterinary medicines. This paper, which is now open for public...

Q&A on practical aspects related to the implementation of Regulation (EU) 2023/607 amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards the transitional provisions for certain medical devices and in vitro diagnostic medical devices   Introduction –...

O INFARMED, I.P. pretende iniciar o projeto piloto eFI (Folheto Informativo em formato eletrónico), que consiste na retirada dos folhetos informativos em papel das embalagens de medicamentos destinadas a ser comercializadas apenas no circuito hospitalar e para...

Bold policies and increased investments in Research & Development are necessary to contribute to the success of Europe’s digital and green agenda. This can help enhance resilience and technological sovereignty, and strengthen the competitiveness of our single...

Briefing 28-06-2023 The European Commission tabled a proposal for an EU regulatory framework on artificial intelligence (AI) in April 2021. The draft AI act is the first ever attempt to enact a horizontal regulation for AI. The proposed legal framework focuses on the...

  Overview This publication presents the findings of a global horizon scan of innovations in science and technology that could help solve global health challenges.  An expert group scored over 100 innovations for their potential impact and the chance of wide...

THE EUROPEAN COMMISSION, Having regard to the Treaty on the Functioning of the European Union, Having regard to Regulation (EU) No 1025/2012 of the European Parliament and of the Council of 25 October 2012 on European standardisation, amending Council Directives...

On the heels of the most severe pandemic in decades, European healthcare systems are facing a perfect storm of ageing populations, growing prevalence of chronic diseases, significant health workforce shortages, and the unfolding energy, climate, cost of living, and...

Scope of the Guideline To outline the practical arrangements for notification of serious breaches; this document does not cover notifications related to unexpected events, other reporting obligations related to the safety of trial participants or urgent safety...

As part of the EU Pharmaceuticals Strategy, and lessons learned from the COVID-19 pandemic, the European Commission (EC) declared its plans to assess and revise the EU’s general legislation on medicines for human use (Directive 1001/83/EC and Regulation 776/2004) to...

This document has been endorsed by the Medical Device Coordination Group (MDCG) established by Article 103 of Regulation (EU) 2017/745. The MDCG is composed of representatives of all Member States and it is chaired by a representative of the European Commission. The...

“Excelente formação , apresentada com muita clareza e casos práticos que serão muito úteis no dia a dia . Espaço para  questões e esclarecimento de dúvidas. Muita empatia, conhecimentos e disponibilidade da formadora. “  GILEAD   Mais uma edição da formação...

Generative AI deployment could unlock potential value equal to 2.6 to 4.5 percent of annual revenues across the pharmaceutical and medical-product industries   Our analysis finds that generative AI could have a significant impact on the pharmaceutical and...

News 23/06/2023 Real-world evidence (RWE) from studies led by regulators can complement evidence from other sources including clinical trials. RWE can support both pre-authorisation and post-approval assessments of EMA’s scientific committees, working parties...

The healthcare sector is grappling with critical challenges, such as a shortage of frontline workers, health disparities and escalating spending. Artificial intelligence (AI) promises transformative potential to tackle these issues.   The healthcare sector is...

  O manual tem o objetivo de orientar os importadores sobre as regras para submissão e os procedimentos de análise de processos de importação de dispositivos médicos sob responsabilidade do Posto de Anuência de Importação de Produtos para Saúde (PAFPS). Os...

Decorreu no dia 23 de junho a sessão formativa :REGULATORY MEDICAL WRITING, bajo o lema  "Técnicas base e boas práticas da escrita médica para criar documentos precisos, submission-ready, e com uma mensagem eficaz" ;  um Workshop Prático para aperfeiçoar as ...

  Teve lugar no dia 22 de junho o workshop prático : VALIDAÇÃO de MÉTODOS ANALÍTICOS   conduzido pela reconhecida especialista Dra Sandra Almeida, Responsável de Controlo de Qualidade, da  CANNAPAC Este workshop teve como objetivo oferecer um conhecimento...

Press Release: ICH Assembly Meeting, Vancouver, Canada, June 2023 20 June 2023 New Areas of Harmonisation Adopted, Alongside Significant Advancement of Ongoing Activities The Assembly of the International Council for Harmonisation (ICH) met in-person on 12 & 13...

The Investigations Operations Manual (IOM) is the primary operational reference for FDA employees who perform field activities in support of the agency’s public health mission. Accordingly, it directs the conduct of all fundamental field activities. Adherence to this...