NOTICIAS

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...

  The EU Commission has today published 'Notified Bodies Survey on certifications and applications (MDR/IVDR) Survey results with data status 30 June 2023 (medium and small dataset)' The aim of the study is to support monitoring and analyzing the availability of...

The WHO Classification of digital interventions, services and applications in health (CDISAH) categorizes the different ways in which digital health interventions used in digital applications and services are used to address individual and health sector needs and...

Europe takes great pride in its robust social security systems and the fundamental principles of equitable healthcare access. Medical technologies form an integral part of such quality healthcare and are crucial for all stages of the patient journey, from prevention...

The European Medicines Agency EMA has published a so called "MSSG Toolkit on recommendations on tackling shortages of medicinal products", a guidance document for use by the MSSG to facilitate identification of recommendations on critical shortages of medicinal...

“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...