NOTICIAS

Factsheet for Manufacturers of Medical Devices

This Factsheet is aimed at manufacturers of medical devices. For a general overview of the impact of the In-VitroMedical Devices Regulation (IVDR) on manufacturers see the Factsheet for manufacturers of in-vitro diagnostic medical devices. References to Annexes and...

Quality requirements for drug-device combinations

Draft guideline on the quality requirements for drug-device combinations (PDF/302.99 KB) Draft: consultation open First published: 03/06/2019 Consultation dates: 03/06/2019 to 31/08/2019 EMA/CHMP/QWP/BWP/259165/2019 Guidance is provided on dossier requirements for...

Questions and answers: Requirements relating to notified bodies

The European Commission (EC) issued a Q&A document  to clarify new obligations under the medical device and in vitro diagnostic regulations (MDR/IVDR) regarding notified bodies (NBs). This document presents questions and answers on requirements relating to...

INFARMED Circular Informativa: Alegações em produtos cosméticos

Os novos elementos contidos no documento técnico : Technical document on cosmetic claims,, são aplicáveis aos cosméticos disponibilizados no mercado a partir de 1 de julho de 2019.   Alegações em produtos cosméticos (Circular Informativa N.º 097/CD/550.20.001...

Personalized Medical Devices – Regulatory Pathways

The 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 category of...

Real World Data e Real World Evidence

Estreitamente ligado a conceitos como Patient Centrity, a RWE está emergindo como uma área crítica de conhecimento nas empresas farmacêuticas, envolvendo várias funções, como HEOR, Medical Affairs, Market Access, R&D e comercial Real world data (RWD) e real world...

ICH Revised Guideline on General Considerations for Clinical Studies

The ICH document "General Considerations for Clinical Studies" is intended to:  1. Describe internationally accepted principles and practices in the design and conduct of clinical studies that will facilitate acceptance of data and results by regulatory authorities...

DATA INTEGRITY in GxP enviroments: A Formação superou as expectativas

Decorreu no passado dia 7 de maio a  3ª edição da formação sobre  DATA INTEGRITY in a GxP enviroments, bajo o lema "Procedimentos para assegurar a integridade dos dados, demonstrar a sua exactidão e coerência, e garantir a qualidade da informação". A integridade dos...

NOVA LEI DOS ENSAIOS CLÍNICOS

NOVA LEI DOS ENSAIOS CLÍNICOS | Proposta de Lei n.º 199/XIII, que visa assegurar a execução, na ordem jurídica interna, do Regulamento (UE) n.º 536/2014 do Parlamento e do Conselho, de 16 de abril de 2014, relativo aos ensaios clínicos de medicamentos para uso...

New FDA Guidance Answers Questions On RBM Use

This document provides guidance on risk-based approaches to monitoring investigational studies  of human drug and biological products, medical devices, and combinations thereof. This guidance contains recommendations on planning a monitoring approach, developing the...

FDA Guidance .When a REMS is Necessary

The 10-page guidance explains how the Food and Drug Administration Amendments Act  requires FDA to consider the following six factors in deciding whether to require a REMS:  “The seriousness of any known or potential adverse events that may be related to the drug and...

FRAMEWORK FOR FDA’S REAL-WORLD EVIDENCE PROGRAM

Real world data (RWD) and real world evidence (RWE) are playing an increasing role in health care decisions. FDA uses RWD and RWE to monitor postmarket safety and adverse events and to make regulatory decisions. The health care community is using these data to support...

Making Real-World Evidence More Useful for Decision Making

Real-world evidence (RWE) holds enormous promise, with some of that promise beginning to be realized in the evaluation of harms. However, in order to accomplish major strides in harms assessment, and ultimately in the evaluation of effectiveness, many steps have to be...

Regulatory Science to 2025

The European Medicines Agency's (EMA) draft 'Regulatory Science to 2025' strategy is a plan for advancing EMA's engagement with regulatory science over the next five to ten years, covering both human and veterinary medicines. In December 2018, EMA published the draft...

New guidance documents related to a no-deal scenario

MHRA released six  new guidance documents related to a no-deal scenario —five on importing and exporting medicines and active substances, and one on pediatric studies Importing and exporting Importing medicines from an EEA State which is on an approved country for...

MHRA guidance and publications on a possible no deal scenario

Information about the regulation of medicines and medical devices if the UK leaves the EU with no deal. Published 31 January 2019  Last updated 7 March 2019 — see all updates From: Medicines and Healthcare products Regulatory Agency Contents Medical devices...

First guidance on new rules for certain medical devices

 EMA has published today the first of a series of guidance documents to help applicants prepare for obligations stemming from the new EU regulations on medical devices . The new regulations introduce new roles and responsibilities for EMA and national competent...