NOTICIAS
Formação sobre as BOAS PRÁTICAS de FARMACOVIGILÂNCIA: ” Muito completa, bem organizada e com um excelente formador “
Teve lugar os dias 16 e 17 de novembro a 7ª edição da formação sobre as BOAS PRÁTICAS de FARMACOVIGILÂNCIA,com o objetivo de lhe oferecer uma abordagem específica dos aspetos mais críticos e actuais relacionados com a gestão da qualidade, riscos, inspeções, etc.....
Formação PESSOA RESPONSÁVEL de DISPOSITIVOS MÉDICOS: “Uma Excelente ferramenta de trabalho”
No dia 16 de novembro teve lugar em Lisboa a 3ª edição da formação PESSOA RESPONSÁVEL de DISPOSITIVOS MÉDICOS, bajo o lema " Uma revisão completa e exaustiva dos pontos críticos para garantir o cumprimento permanente dos requisitos e obrigações MDR durante o ciclo...
Concept Paper on the revision of Annex 11 of the guidelines on Good Manufacturing Practice for medicinal products – Computerised Systems
This concept paper addresses the need to update Annex 11, Computerised Systems, of the Good Manufacturing Practice (GMP) guide. Annex 11 is common to the member states of the European Union (EU)/European Economic Area (EEA) as well as to the participating...
Contribution of Real-World Evidence in European Medicines Agency’s Regulatory Decision Making
Real-world data/evidence (RWD/RWE) may provide insightful information on medicines' clinical effects to guide regulatory decisions. While its contribution has been recognized for safety monitoring and disease epidemiology across medicines' life cycles, using RWD/RWE...
A Formiventos é uma das Top 5% melhores PME de Portugal
É com grande satisfação que anunciamos que a Formiventos é uma empresa certificada TOP 5% MELHORES PME PORTUGAL, edição de 2022, certificação atribuída pela SCORING, em termos de desempenho e solidez financeira. Este feito é motivo de orgulho para toda a equipa e...
Boas Praticas de Fabrico da Canabis Medicinal: ” Uma ótima formação, muito interessante e valida para a prática do dia-a-dia”
Nos dias 9 e 10 de novembro teve lugar a 6ª edição da formação GMP para Canábis para fins medicinais, conduzida por André Luz, da Owlpharma Uma formação que ofereceu um enquadramento global muito completo , e que aborda todos os pontos chave a aplicar na...
An Introduction to FDA’s Regulation of Medical Devices
FDA NEW PRESENTATION: An Introduction to FDA’s Regulation of Medical Devices. Explain FDA’s role in regulating medical devices: • Define a medical device and review basics about device classification • Describe five steps to get a new product to market •...
Referencing the Definition of “Device” in the Federal Food, Drug, and Cosmetic Act in Guidance, Regulatory Documents, Communications, and Other Public Documents
FDA is issuing this guidance to clarify our approach for referencing the terms “device” and “counterfeit device” in FDA documents. For many years, the definition of “device” has been codified at section 201(h) of the Federal Food, Drug, and Cosmetic Act...
Regulatory Affairs da Canábis Medicinal : “Formação abrangente de todos os temas que tocam a regulamentação da Canábis Medicinal , de uma forma sucinta e clara
No dia 28 de outubro teve lugar a 3 ª ediçaõ da formação sobre Regulatory Affairs da Canábis Medicinal, , uma formação exclusiva para a análise dos requisitos para a instrução dos pedidos e procedimentos relativos à concessão de autorizações para o exercício das...
MDCG 2019-6 Rev.4 – Questions and answers: Requirements relating to notified bodies (October 2022)
This document presents questions and answers on requirements relating to notified bodies under Regulation (EU) 2017/745 on medical devices (MDR) and Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR). The issues covered by this document have...
MDCG 2022-16 Guidance on Authorised Representatives Regulation (EU) 2017/745 on medical devices (MDR) and Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR)
This guidance document is written for authorised representatives, manufacturers and other economic operators, and intends to provide guidance on relevant requirements under the Regulations. Where clarification is already covered by other MDCG guidances, this guidance...
Notified Bodies Survey on certifications and applications(MDR/IVDR) MDCG & Stakeholders 24 Oct 2022
EU MDR/IVDR News! (certifications and applications) Notified Bodies Survey on certifications and applications(MDR/IVDR) MDCG & Stakeholders 24 Oct 2022 General data of Notified bodies replies received – October 2022 Slides 6 & 7 describes well the state...
Formação sobre AUDITORIA DE QUALIDADE : “Muito positiva, com abordagem nos topics todos necessários para a elaboração de uma auditoria interna”
Decorreu a 1ª edição da formação AUDITORIA INTERNA da QUALIDADE , bajo o lema Boas Práticas no Planeamento, realização e relatórios; classificação e follow-up das não conformidades, e avaliação da eficácia das CAPAS, conduzida pela especialista Dra. Marta Monteiro...
ICH releases M11 guideline proposing harmonized template for trial protocols
The International Council for Harmonisation (ICH) has released a draft guideline which outlines a harmonized template for clinical trial protocols to support consistent reporting among sponsors. The draft guideline, as well as the template and specifications for the...
MDR/IVDR IMPLEMENTATION ROLLING PLAN: Latest update: October 2022
MDR/IVDR IMPLEMENTATION ROLLING PLAN: Latest update: October 2022 Regulation (EU) 2017/745 and Regulation (EU) 2017/746 This rolling plan contains a list of identified essential implementing acts and other relevant initiatives that the Commission has adopted...
FDA Advancing Real-World Evidence Program
As announced in the Federal Register notice published on October 20, 2022, FDA is conducting an Advancing Real-World Evidence (RWE) Program, which seeks to improve the quality and acceptability of RWE-based approaches in support of new intended labeling claims,...
UK Regulation News : New Regulations Implementation deadline – Medical Devices – IVDs
Future regulation of medical devices – extension of standstill period "We are therefore putting in place a twelve-month extension to the current standstill period, aiming to bring the new regulations into force in July 2024. This will provide additional time to...
Good Practice Guide for the use of the Metadata Catalogue of Real-World Data Sources
The Good Practice Guide aims to provide recommendations for the use of the EU metadata catalogue to identify real-world data sources suitable for specific research questions and to assess the suitability of data sources proposed to be used in a study...
High-quality data to empower data-driven medicines regulation in the European Union
PUBLISHED BY EMA News 10/10/2022 EMA and the Heads of Medicines Agencies (HMA) in the EU Member States are moving ahead with their ambitious agenda to increase access and improve the quality of the data that underpin decision-making on the benefits and risks of...
Procedures for Handling Post-Approval Studies Imposed by Premarket Approval Application Order
Evaluation of premarket approval applications (PMA) by the Food and Drug Administration (FDA) is a multi-step process in which we evaluate whether reasonable assurance of device safety and effectiveness has been demonstrated. To provide reasonable assurance, or the...
FDA new guidance on Postmarket Surveillance
Section 522 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) provides the Food and Drug Administration (FDA) with the authority to require manufacturers to conduct postmarket surveillance at the time of approval or clearance or at any time thereafter...
As formações de outubro e novembro , já prontas para avançar, recebem os creditos da OF
Algunas das formações previstas para os próximos meses , recebem as creditações da Ordem dos Farmacêuticos. Novas creditações para as próximas formações de outubro e novembro: BOAS PRÁTICAS de FARMACOVIGILÂNCIA 16 e 17 de novembro de 2022...
FDA GUIDANCE : Size, Shape, and Other Physical Attributes of Generic Tablets and Capsules
Tablets and capsules are widely manufactured and prescribed and may provide a number of advantages over other dosage forms, including ease of storage, portability, ease of administration, and accuracy in dosing. While generic formulations of these drug products are...
Medicinal cannabis monograph proposed by US Pharmacopeia
A monograph outlining the analytical methods and acceptance criteria for cannabis chemotypes has been released for comment by USP’s Herbal Medicines Compendium. The United States Pharmacopeia (USP) has opened a 90-day review period for their...
Digital Health Software Precertification (Pre-Cert) Pilot Program
In September 2022, the Software Precertification (Pre-Cert) Pilot Program was completed with the issuance of the Report: The Software Precertification (Pre-Cert) Pilot Program: Tailored Total Product Lifecycle Approaches and Key Findings. The FDA launched the Software...
New liability rules on products and AI to protect consumers and foster innovation
Today, the Commission adopted two proposals to adapt liability rules to the digital age, circular economy and the impact of global value chains. Firstly, it proposes to modernise the existing rules on the strict liability of manufacturers for defective products (from...
FDA GUIDANCE DOCUMENT : Clinical Decision Support Software
Section 3060(a) of the 21st Century Cures Act (Cures Act), enacted on December 13, 2016, amended section 520 of the Federal Food, Drug & Cosmetic Act (FD&C Act) to exclude certain medical software functions, including certain decision support software,...
FDA NEW GUIDANCE : Policy for Device Software Functions and Mobile Medical Applications
FDA is issuing this guidance to communicate how the Agency intends to apply its regulatory oversight to certain software, including device software functions and mobile medical applications (MMAs) intended for use on mobile platforms or on general-purpose...
Team-NB Position Paper on Hybrid Audit
New position paper released by Team-NB related to 'Notified bodies’ paper on the application of hybrid audits to quality management system assessments under MDR/IVDR'. Hybrid audits in the context of legislative requirements Notified bodies are required to undertake...
KPGM INSIGHTS : Medical devices 2030
Published by KPMG Stake your claim in the medical device value chain of the future and avoid the commodity trap. While the outlook for medical device companies appears positive, unsustainable healthcare costs and new competitive forces threaten to alter the...
Electronic Submission Template for Medical Device 510(k) Submissions
This guidance provides the further 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...
Fabrico de medicamentos estéreis: publicação da nova versão do Anexo 1 do Guia das Boas Práticas de Fabrico
O Anexo 1 do Guia das Boas Práticas de Fabrico (EudraLex, Volume 4, Parte I), referente a orientações sobre o fabrico de medicamentos estéreis, foi revisto por forma a englobar alterações relacionadas com as condições ambientais no âmbito do fabrico de medicamentos...
MDCG 2022-15 Guidance on appropriate surveillance regarding the transitional provisions under Article 110 of the IVDR with regard to devices covered by certificates according to the IVDD
EU IVDR News ( Article 110) MDCG 2022-15 Guidance on appropriate surveillance regarding the transitional provisions under Article 110 of the IVDR with regard to devices covered by certificates according to the IVDD This guidance document outlines the activities to be...
Computer Software Assurance for Production and Quality System Software
FDA is issuing this draft guidance to provide recommendations on computer software assurance for computers and automated data processing systems used as part of medical device production or the quality system. This draft guidance is intended to: · Describe...
IMDRF released Update on EU regulatory developments
imdrf
EU MDR & IVDR News (Device Borderline and Classification)
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...
Designation, re-assessment and notification of conformity assessment bodies and notified bodies
This document1 aims to provide guidance to the authorities responsible for notified bodies (hereafter, the Designating Authorities) and joint assessment teams (JATs) when conducting: i. assessments of conformity assessments bodies (CABs) that apply for designation as...
Patient involvement in the development, regulation and safe use of medicines
The report is the result of four years of work with patient group leaders, academics, industry experts, regulators and other stakeholders, and EMA is pleased to have been involved. Patients are at the centre of modern healthcare and their engagement is critical to...
EU MDR News : Clinical Evaluation Report
Background note on the relationship between MDCG 2020-6 and MEDDEV 2.7/1 rev. 4 on clinical evaluation MDCG 2020-6 document Regulation (EU) 2017/745: Clinical evidence needed for medical devices previously CE marked under Directives 93/42/EEC or 90/385/EEC - A...
Dispositivos médicos: Lista de ações para facilitar a transição para as regras europeias e evitar ruturas no mercado
PUBLICADO NO SITE INFARMED 01 set 2022 Os Regulamentos dos dispositivos médicos, que entraram em vigor a 26 de Maio de 2021, representam uma atualização importante às diretivas até então existentes e pretendem fortalecer e melhorar o sistema europeu, garantindo maior...
Commission presents guideline to avoid medical devices shortage
Following a warning from health ministers, the EU executive agreed on a list of actions to ease the transition into the new framework for medical devices as its sluggish implementation threatens a shortage in Europe. The list was approved by the Medical Device...
Accelerating Clinical Trials in the EU: publication of 2022-2026 workplan
PUBLISHED BY EMA News 30/08/2022 The European Commission (EC), the Heads of Medicines Agencies (HMA) and the European Medicines Agency (EMA) have published the 2022-2026 workplan of the initiative Accelerating Clinical Trials in the EU (ACT EU). ACT EU, launched in...
EU GMP Annex 1 has just been published
After many years, the final revision to Annex 1 "Manufacture of Sterile Medicinal Products," under the The Rules Governing Medicinal Products in the European Union Volume 4 EU Guidelines for Good Manufacturing Practice for Medicinal Products for Human and Veterinary...
Publicada a nova versão da metodologia de avaliação farmacoterapêutica de tecnologias de saúde
publicado no site INFARMED 05 ago 2022 Na sequência da Deliberação N.º 76/CD/ 2022 de 29 de julho foi aprovada a versão 3.0 da Metodologia de Avaliação Farmacoterapêutica, a qual produz efeitos a 1 de novembro de 2022. Decorrente dos desafios metodológicas...
Big data use for public health: publication of Big Data Steering Group workplan 2022-25
Published by EMA News 28/07/2022 The Big Data Steering Group set up by EMA and the Heads of Medicines Agencies (HMA) has published its PDF icon third workplan that sets key actions to be delivered between 2022–25. The new workplan will allow to further enhance...
Global regulators call for international collaboration to integrate real-world evidence into regulatory decision-making
PUBLISED BY EMA News 22/07/2022 EMA has endorsed a joint statement calling for international collaboration to enable the generation and use of real-world evidence for regulatory decision-making published today by the International Coalition of Medicines Regulatory...
FDA Evaluation of Therapeutic Equivalence Guidance for Industry
This guidance explains FDA’s therapeutic equivalence evaluations, including the assignment of therapeutic equivalence codes (or TE codes). As defined in 21 CFR 314.3(b), therapeutic equivalents are: approved drug products that FDA has determined are pharmaceutical...
EUROPEAN COMMISSION Serialization – Version 20 of the Q&As on Safety Features
The European Commission published version 20 of the Questions & Answers (Q&As) regarding the safety features for medicinal products for human use. Compared to the previous version 19, the new version contains one new Q&A. This documents sets out...
MedTech Europe Survey Report analysing the availability of In vitro Diagnostic Medical Devices (IVDs) in May 2022 when the new EU IVD Regulation applies
MedTech Europe Survey Report – Analysing the availability of Medical Devices in 2022 in connection to the Medical Device Regulation (MDR) implementation During the month of April 2022, MedTech Europe members participated to a survey commissioned by the Medical Device...
NEW Industry contact points for supply and availability of critical medicines
Marketing authorisation holders for all authorised medicines in the EU are required to appoint a so-called industry single point of contact (i-SPOC) who can provide information directly to EMA about the supply and availability of critical...
EMA launches pilot project on analysis of raw data from clinical trials
PUBLISHED BY EMA News 12/07/2022 EMA has launched a pilot project to assess whether the analysis of ‘raw data’ from clinical trials by regulatory authorities improves the evaluation of marketing authorisation applications (MAAs) for new medicines as well as...