NOTICIAS
FDA Study Data Technical Conformance Guide – Technical Specifications Document
This Guide provides technical recommendations to sponsors4 for the submission of animal and human study data and related information in a standardized electronic format in INDs, NDAs, ANDAs, and BLAs. The Guide is intended to complement and promote interactions...
GESTÃO DE RISCOS no Sistema de Gestão de Qualidade : ” Formação atual e prática de gestão de riscos”
Teve lugar no 17 de maio a formação sobre a GESTÃO DE RISCOS no Sistema de Gestão de Qualidade; uma formação exclusiva, com o objetivo de fornecer uma ocasião única de abordar a gestão de riscos no sistema de qualidade, de uma forma transversal a todo o ciclo...
ICH HARMONISED GUIDELINE GOOD CLINICAL PRACTICE (GCP) E6(R3)
Good Clinical Practice (GCP) is an international, ethical, scientific and quality standard for the conduct of trials that involve human participants. Clinical trials conducted in accordance with this standard will help to assure that the rights, safety and...
AUDITORIAS e INSPEÇÃO em FARMACOVIGILÂNCIA: “Abordagem teórico-prática muito útil e equilibrada, com uma formadora especialista na área e muito experiente , recheada de casos práticos”
Decorreu no passado 17 de maio , em Lisboa, uma nova edição da formação sobre as AUDITORIAS e INSPEÇÃO em FARMACOVIGILÂNCIA, com o objetico de proporcionar aos assistentes bases sólidas, experiências práticas e conhecimentos cruciais para desenvolver as...
REGULATORY NEWS: Guidance for industry to prevent and mitigate medicine shortages
This paper focuses on proactive mechanisms to prevent shortages of medicines for human use. As patients and healthcare professionals are the main actors at the end of the supply chain, their activities in preventing shortages are usually limited to demand management...
New EMA Guidelines and Revisions in GMP Area
Publlished by https://www.gmp-compliance.org/ The European Medicines Agency (EMA) has published a new version of the "3-year work plan for the Quality domain" for the period January 2021 - December 2023. The plan is being prepared by the GMP/GDP Inspectors...
EMA: Updates PLM Portal eAF timeline (April 2023) of eAFs for Variations for Medicinal Products for Human Use
In future, submissions of #variation notifications for #medicinalproducts for human use are to be made exclusively via the electronic application forms (#eAFs). The timelines for the full implementation of these systems have now been updated again and are listed on...
EMA annual report 2022 published
EMA published its annual report 2022 today. The report provides an overview of the Agency’s activities to protect and promote public and animal health in the European Union (EU). The digital report outlines the most important highlights regarding the evaluation and...
PESSOA RESPONSÁVEL COSMÉTICOS & PRODUCT INFORMATION FILE : “Esta formação foi extremamente útil e esclarecedora”
Decorreu no passado 11 de maio , a primeira edição da sessão sobre PESSOA RESPONSÁVEL COSMÉTICOS & PRODUCT INFORMATION FILE ,uma formação completa e avançada, para atualização e aprofundamento de conhecimento e competências no que diz respeito à regulamentação...
Guidance on significant changes regarding the transitional provision under Article 120 of the MDR with regard to devices covered by certificates according to MDD or AIMDD
Article 120(3) of the Medical Device Regulation (EU) 2017/745 (MDR), last amended by Regulation (EU) 2023/607, states that devices which continue to comply with the AIMDD or MDD may be placed on the market or put into service until 31 December 20271 or 31...
COSMETIC CONTENT WRITING & ALEGAÇOES DE SUSTENTABILIDADE: “Formação completa e abrangente”
No dia 11 de maio de 2023 decorreu uma nova sessão formativa para a área de Cosméticos : COSMETIC CONTENT WRITING & ALEGAÇOES DE SUSTENTABILIDADE, bajo o lema "Técnicas para a escrita e Best Practices para a comunicação de conceitos de composição e...
Artificial Intelligence and Machine Learning (AI/ML) for Drug Development
What is Artificial Intelligence and Machine Learning? Artificial Intelligence (AI) and Machine Learning (ML) can be described as a branch of computer science, statistics, and engineering that uses algorithms or models to perform tasks and exhibit behaviors such as...
Toolbox guidance on scientific elements and regulatory tools to support quality data packages for PRIME and certain marketing authorisation applications targeting an unmet medical need – Scientific guideline
This guidance summarises scientific and regulatory approaches that developers of medicines supported by EMA’s PRIME scheme can use to generate robust quality data packages for an EU marketing authorisation application, to enable patients to benefit from these...
Formação muito esclarecedora e bem estruturada , com casos práticos pertinentes
Teve lugar no dia 11 de maio uma nova edição da formação PROMOTIONAL REVIEW COMPLIANCE & BEST PRACTICES; uma excelente oportunidade de partilha de experiências entre os colegas e de revisitar alguns aspetos da legislação Nesta formação os participantes tiveram a...
Proposal for a REGULATION : HARMONISED RULES ON ARTIFICIAL INTELLIGENCE
Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL LAYING DOWN HARMONISED RULES ON ARTIFICIAL INTELLIGENCE (ARTIFICIAL INTELLIGENCE ACT) AND AMENDING CERTAIN UNION LEGISLATIVE ACTS This explanatory memorandum accompanies the proposal for a...
FDA Q9(R1) Quality Risk Management MAY 2023
The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled “Q9(R1) Quality Risk Management.” The guidance was prepared under the auspices of the International Council for Harmonisation of Technical...
AI Act: a step closer to the first rules on Artificial Intelligence
Once approved, they will be the world’s first rules on Artificial Intelligence MEPs include bans on biometric surveillance, emotion recognition, predictive policing AI systems Tailor-made regimes for general-purpose AI and foundation models like GPT The right to make...
EU Latest developments on AMR as part of the pharmaceutical package
IMPORTANT DOCUMENTS ON ANTIMICROBIAL RESISTANCE RELEASED TODAY BY THE EUROPEAN COMMISSION On 26 April 2023, the European Commission adopted a proposal for a Council Recommendation on stepping up EU actions to combat antimicrobial resistance in a One Health approach,...
Glossary of ICH terms and definitions
This is a cumulative Glossary of terms and definitions included in the ICH guidelines, compiled from the guidelines posted at www.ich.org. Version 3, 20 April 2023 — This glossary combines the terms and definitions included in the guidelines of the International...
COMMISSION GUIDANCE on the content and structure of the summary of the clinical investigation report
This document is intended to provide Commission guidance, in accordance with Article 77(6) of Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices (hereafter: the MDR), for the content and structure of the summary...
ISPOR – Early Scientific Advice in Europe: An Overview of Processes and Requirements
OBJECTIVES: Early scientific advice comprises a systematic process through which national Health Technology Assessment (HTA) bodies provide manufacturers with guidance on their clinical development strategy, aiming to improve the quality of evidence to be submitted....
GUIDANCE DOCUMENT Decentralized Clinical Trials for Drugs, Biological Products, and Devices .MAY 2023
This draft guidance provides recommendations for sponsors, investigators, and other stakeholders regarding the implementation of decentralized clinical trials (DCTs) for drugs, biological products, and devices. In this guidance, a DCT refers to a clinical trial...
FDA PRESENTATION Submitting in eCTD: Most Common Submission Issues and FDA Plans for eCTD v4.0
Submitting in eCTD: Most Common Submission Issues and FDA Plans for eCTD v4.0: • eCTD Guidance • Most Common Reasons for Technical Rejection Notice • eCTD Validations and Study Data • Frequently Asked Questions to eSub • FDA Plans for Implementation of...
Review of transparency rules for the EU Clinical Trials Information System (CTIS)
News 03/05/2023 EMA has opened a public consultation to review the PDF icon transparency rules for the publication of information on clinical trials submitted through the Clinical Trials Information System (CTIS) in the European Union (EU). Stakeholders are invited to...
GUIDANCE DOCUMENT Q9(R1) Quality Risk Management. MAY 2023
The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled “Q9(R1) Quality Risk Management.” The guidance was prepared under the auspices of the International Council for Harmonisation of Technical...
Decentralized Clinical Trials for Drugs, Biological Products, and Devices
This draft guidance provides recommendations for sponsors, investigators, and other stakeholders regarding the implementation of decentralized clinical trials (DCTs) for drugs, biological products, and devices. In this guidance, a DCT refers to a clinical trial...
US National Artificial Intelligence Advisory Committee (NAIAC) Year l MAY2023
For the purposes of this report, the definition of an AI system is one that was established as a best practice in the recently released NIST AI RMF: “An AI system is an engineered or machine-based system that can, for a given set of objectives, generate outputs such...
Establishing efficacy based on single-arm trials submitted as pivotal evidence in a marketing authorisation
This reflection paper is intended to reflect the current thinking of EMA's Committee for Medicinal Products for Human Use (CHMP) on single-arm trials (SATs) that are submitted as pivotal evidence for establishing efficacy in a marketing authorisation application....
DATA INTEGRITY NEWS : APIC Data Integrity Frequently Asked Questions (FAQ)
This document contains a collection of frequently asked questions that have been submitted by the industry to the DI taskforce. The intention of this documents is that this is a living document that will be updated as new questions are opposed to the group. The...
Guidance on the details of the classification of variations requiring assessment according to Article 62 of Regulation (EU) 2019/6 for veterinary medicinal products and on the documentation to be submitted pursuant to those variations
This guidance is intended to explain the practice of Articles 60 to 68 of Regulation (EU) 2019/6 of the European Parliament and of the Council of 11 December 2018 on #veterinarymedicinalproducts, laying down rules for the placing on the market, manufacturing, import,...
European Health Union: Commission proposes pharmaceuticals reform for more accessible, affordable and innovative medicines
Today, the Commission is proposing to revise the EU's pharmaceutical legislation - the largest reform in over 20 years - to make it more agile, flexible, and adapted to the needs of citizens and businesses across the EU. The revision will make medicines more...
Revision of the Pharmaceutical legislation
The Commission is proposing an ambitious revision of the EU pharmaceutical legislation to achieve the following main objectives: Create a Single Market for medicines ensuring that all patients across the EU have timely and equitable access to safe, effective, and...
Team-NB PP: “Best Practice Guidance for the Submission of Technical Documentation under Annex II and III of In Vitro Diagnostic Medical Devices Regulation”
Scope of Document This best practice guidance document has been developed by members of Team NB who have reviewed the best practice guidance documents submitted by individual Team NB notified body members, with the purpose to develop a unified approach on the...
AI watch, evolution of the EU market share of robotics Data and methodology
This report addresses the following objectives of AI Watch: with the aim to study the evolution of the European market shares in robotics over the past ten years, this report i) offers a brief overview of the robotics industry; ii) reviews the scientific and...
Formação sobre PREÇOS 2023 : “Muito esclarecedora, bem sintetizada e clara com vários exemplos práticos e atuais”
Decorreu no passado dia 20 de abril a formação sobre Aprovação, Formação e Revisão anual de PREÇOS de MEDICAMENTOS, bajo o lema : " Um guia completo para o desenvolvimento da estratégia de pedido de preço de medicamentos, e para a revisão anual de preços de...
ICH Guideline M13A on bioequivalence for immediate-release solid oral dosage forms
This guideline is intended to provide recommendations on conducting bioequivalence (BE) studies during both development and post approval phases for orally administered immediate-release (IR) solid oral dosage forms designed to deliver drugs to the...
A pro-innovation approach to AI regulation
Presented to Parliament by the Secretary of State for Science, Innovation and Technology by Command of His Majesty on 29 March 2023. Command Paper Number: 815 © Crown copyright 2023 The proposed regulatory framework Our innovative approach to...
AEMPS Garantías sanitarias dos produtos cosméticos
Fecha de publicación: 17 de abril de 2023 Los productos cosméticos forman parte de la vida cotidiana de las personas, ya que se emplean diariamente en su cuidado e higiene. Por esta razón, es esencial confiar en su seguridad y transmitir a la ciudadanía su alto...
Alteração das instruções aos requerentes de pedidos de alteração, renovação e transferência de titular de AIM
Publicado no site infarmed : www.infarmed.pt. 17 abr 2023 Para: Requerentes e Titulares de Autorização de Introdução no Mercado (TAIM) Circular Informativa N.º 032/CD/100.20.200 Data: 14/04/2023 O INFARMED, I.P. procedeu a uma revisão das instruções aos requerentes...
Comparison of EU GMP Guidelines with WHO Guidelines
Two directives laying down principles and guidelines of GMP for medicinal products were adopted by the European Commission. Directive 2003/94/EC applies to medicinal products for human use and Directive 91/412/EEC for veterinary use. Detailed guidelines in accordance...
Personalized Medical Devices – Production Verification and Validation
The purpose of this IMDRF guidance is to provide harmonized recommendations for verification and validation aspects of a patient-matched medical device and a medical device production system (MDPS). The adoption of consistent, harmonized requirements for such medical...
Principles and Practices for the Cybersecurity of Legacy Medical Devices
Published date 11 April 2023 Status Final 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...
FDA New guidance: A Risk-Based Approach to Monitoring of Clinical Investigations Questions and Answers
Sponsors of clinical investigations involving human drugs, biological products, medical devices, and combination products are required to provide oversight, including ensuring proper monitoring of the investigation. Such oversight helps to ensure adequate protection...
FDA GUIDANCE ON AI: Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence/Machine Learning (AI/ML)-Enabled Device Software Functions
FDA is issuing this draft guidance to further develop a regulatory approach tailored to artificial intelligence/machine learning (AI/ML)-enabled devices to increase patients’ access to safe and effective AI/ML-enabled devices, in order to protect and promote public...
(Q&A) sobre aspetos práticos relacionados com a implementação do Regulamento (UE) 2023/607 – Extensão do período transitório do Regulamento dos Dispositivos Médicos e eliminação das datas “sell off”
No dia 20 de março de 2023 entrou em vigor o Regulamento (UE) 2023/607 que altera os Regulamentos (UE) 2017/745 (RDM) e (UE) 2017/746 (RDIV) no que diz respeito às disposições transitórias aplicáveis a determinados dispositivos médicos e dispositivos médicos para...
QUALILFICAÇÃO DE FORNECEDORES 2023: Uma Formação muito bem conduzida , interessante, com aplicação prática no dia à dia
No passado 29 de março teve lugar em Lisboa , uma nova edição da formação Qualificação de Fornecedores ,Clientes e Entidades Subcontratadas , conduzido pela reconhecida especialista Dra Teresa Cruz da MTA Pharma Nesta formação os participantes tiveram a ...
UDI HELPDESK
The new UDI Helpdesk is live The European Commission has launched a new helpdesk to support implementing the requirements introduced by the new Unique Device Identification (UDI) system within the context of the new Medical Device Regulation. The EU Commission...
EXTENSION OF THE MDR TRANSITIONAL PERIOD AND REMOVAL OF THE ‘SELL OFF’ PERIODS
The amendment of the MDR and of the IVDR through Regulation (EU) 2023/607 aims to ensure a high level of public health protection, including patient safety and an avoidance of shortages of medical devices needed for the smooth functioning of healthcare services,...
Framework for the Use of Digital Health Technologies in Drug and Biological Product Development
For the purposes of the Framework, DHTs are systems that use computing platforms, connectivity, software, and/or sensors for health care and related uses. They include technologies intended for use as a medical product, in a medical product, or as an adjunct to other...
Advancing regulatory science in the EU – mid-point report published
PUBLISHED BY EMA News 22/03/2023 EMA has published a reportsummarising the mid-term achievements of its Regulatory Science Strategy (RSS) to 2025. The report provides an overview of the main deliverables achieved between March 2020 and December 2022 across the human...
Amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards the transitional provisions for certain medical devices and in vitro diagnostic medical devices
Regulation (EU) 2023/607 of the European Parliament and of the Council of 15 March 2023 amending Regulations (EU) 2017/745 and (EU) 2017/746 has been published today 20th Martch in the Official Journal of the EU and therefore entered into force today....