NOTICIAS

“Formação de excelência sobre publicidade de Suplementos Alimentares com exemplos práticos que refletem muito bem o que se deve e o que não se deve fazer . “ PHARMAFFAIRS   “Como sempre acontece nas sessões da Formiventos, foi mais uma excelente oportunidade de...

The Commission has adopted today a set of actions to better prevent and mitigate critical medicine shortages in the EU, this winter, next winter and beyond. Recent critical shortages, including of certain antibiotics last winter, show that continued coordinated action...

Today, EMA published  details of the newly created solidarity mechanism developed by the EMA Medicines Shortages Steering Group (MSSG). This voluntary mechanism allows Member States to support each other in the face of a critical medicine shortage. The solidarity...

The EU Commission has today published a Draft EUDAMED RoadMap with updated timelines for each module and mandatory use dates. Q4 2027: Actor, Certificates, MSU, Vigilance and CI/PS (MDR Article 123(3) (d) ) / (IVDR Article 113(3) (f)) Q2 2029: Devices and Certificates...

The intent of this guidance is to clarify for drug sponsors and other stakeholders how considerations about a drug’s benefits, risks, and risk management options factor into certain premarket and postmarket regulatory decisions that the Food and Drug Administration...

“Excelente partilha de dúvidas e situações reais entre os participantes e a formadora. “. PLURAL   Realizou-se na quarta-feira passada a formação  sobre a VALIDAÇÃO de TRANSPORTE em ambiente BPD  bajo o lema " Elaboração, revisão e aprovação do protocolo de...

The World Health Organization (WHO) has released a new publication listing key regulatory considerations on artificial intelligence (AI) for health. The publication emphasizes the importance of establishing AI systems’ safety and effectiveness, rapidly making...

Software has become an increasingly important part of the medical device landscape. It is estimated that one in four medical devices either incorporate medical device software (MDSW)1 or are MDSW in their own right. With the broad public use of smart phones and...

The intent of this guidance is to clarify for drug sponsors and other stakeholders how considerations about a drug’s benefits, risks, and risk management options factor into certain premarket and postmarket regulatory decisions that the Food and Drug Administration...

The guideline specifically concerns bacteriophage products for prophylactic, metaphylactic and/or therapeutic treatment of one or more specific bacterial infection(s) or infectious disease(s) caused by bacteria, or dysbiotic conditions, where efficacy of treatment is...

MedTech Europe has developed this interactive Data Hub to provide the most relevant and up-to-date insights regarding the state of the medical technology industry. Capturing the activity of the medical technology industry is vital for healthcare stakeholders, business...

This guidance document provides a detailed description of the information that should be included in a premarket notification for a magnetic resonance diagnostic device (MRDD). This document is intended to be used in conjunction with information regarding the content...

Since the launch of CTIS in 2022, the deferral functionalities have proven to be complex from an information management and data security perspective, which has led to some uncertainties in the use of CTIS when deferrals were applied. The deferral functionality,...

The European Federation of Pharmaceutical Industries and Associations (EFPIA) is today publishing its official response to the draft Pharmaceutical Legislation [published 26 April]. It reiterates Industry’s view that the proposals, in their current form, would harm...

  Table of contents Reprocessing (3.2.S.2.2, 3.2.P.3.3) Raw materials and media components (3.2.S.2.3) Method identification numbers (3.2.S.4.1, 3.2.P.5.1) Process validation, removal of process related impurities, process related impurities testing (3.2.S.2.5,...

This guidance provides the standards for the submission of premarket notification (510(k)) submissions by electronic format, a timetable for establishment of these standards, and criteria for waivers of and exemptions from the requirements to meet a statutory...

This integrated version has been created for printing purposes only. Please refer to the individual question & answers as published in the pre-submission guidance for access to the hyperlinked information. Questions and answers are being updated continuously and...

Having multiple different strengths of a drug product available in ready-to-use containers from which the entire drug content of the container(s) is administered to the patient may simplify the preparation and administration of a drug compared to preparing and...

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...