NOTICIAS
IMDRF FINAL DOCUMENT: IMDRF Standard Operating Procedures. 24 June 2024
The International Medical Device Regulators Forum (IMDRF) is a voluntary group of medical device regulators from around the world who have come together to build on the strong foundational work of the Global Harmonization Task Force on Medical Devices (GHTF) and aims...
Essential Drug Delivery Outputs for Devices Intended to Deliver Drugs and Biological Products Draft Guidance for Industry
FDA issued a new guidance to help ensure that a device’s drug-delivery function consistently performs as intended including for prefilled syringes, injectors, nasal sprays, and inhalation devices: https://lnkd.in/eGd2hREH FDA welcomes comments on this draft guidance....
MDCG 2021-5 Rev. 1 Guidance on standardisation for medical devices Revision 1 – July 2024
Latest update on MDCG 2021-5 Rev. 1 Guidance for standardization in medical devices! Revision 1, effective from July 2024, offers comprehensive insights into various standardization aspects within the medical devices sector. This guidance aligns with EU legislation...
Good machine learning practice for medical device development – Guiding Principles
Artificial intelligence (AI) technologies, including machine learning, have the potential to transform health care by deriving new and important insights from the vast amount of data generated in health care every day. They use algorithms that can learn from realworld...
Publicação de orientações relativas às Avaliações Clínicas Conjuntas no âmbito do Regulamento (UE) 2021/2282
infarmed. 27 jun 2024 O Grupo de Coordenação dos Estados-Membros para a Avaliação das Tecnologias da Saúde adotou documentos orientadores relativos às Avaliações Clínicas Conjuntas, no âmbito do Regulamento de Avaliação de Tecnologias de Saúde (UE) 2021/2282. Todas as...
Laboratory Developed Tests: Small Entity Compliance Guide
FDA has prepared this Small Entity Compliance Guide to assist small entities in complying with the requirements established in FDA regulations as they apply to in vitro diagnostic products (IVDs), including LDTs. The LDT Final Rule amends FDA regulations to make...
PLANO de PREVENÇÃO de ESCASSEZ : “Abordagem detalhada e partilha de conhecimentos muito útil”
Decorreu no 26 de junho a primeira edição da formação : PLANO de PREVENÇÃO de ESCASSEZ no âmbito da Gestão da Disponibilidade dos Medicamentos; uma formação prática, que inclui análise de casos práticos , focada na partilha de boas práticas e na resolução de questões...
EFPIA The Pharmaceutical Industry in Figures Key Data 2024
With €50 billion invested in R&D in Europe in 2023, the pharmaceutical industry is the sector that invests the greatest percentage of its revenue in R&D. However, last year, China surpassed Europe as a region for launching new active substances globally. After...
Templates a utilizar no âmbito da disponibilidade dos medicamentos
INFARMED 24 jun 2024 Circular Informativa n.º 040/CD/100.20.200 de 24/06/2024 A rede HMA1 e a EMA2 publicou os seguintes templates a ser adotados pelos titulares de autorização de introdução no mercado (AIM) no âmbito da disponibilidade dos medicamentos: Medicine...
Technical document In Vitro Diagnostic Medical Device Market Authorization Table of Contents (IVD MA ToC)
The Regulated Product Submission (RPS) proposal was endorsed as a New Work Item (NWI) by IMDRF at its inaugural meeting in Singapore (March 2012). The proposal, as endorsed, included the objective of establishing a comprehensive harmonized structure for regulated...
MDCG 2024-10 Clinical evaluation of orphan medical devices
This document provides guidance to manufacturers and notified bodies on the clinical evaluation pursuant to the MDR of medical devices and accessories for medical devices that qualify as ‘orphan devices’ (OD) and medical devices and accessories for medical devices...
Norma orientadora sobre as diversas categorias de alterações
O enquadramento regulamentar referente às alterações às autorizações de introdução no mercado (AIM) de medicamentos para uso humano encontra-se em revisão por parte da Comissão Europeia (CE) em conjunto com os Estados-membros. O objetivo desta revisão é estabelecer um...
Update – MDCG 2022-13 Rev.1 – Designation, re-assessment and notification of conformity assessment bodies and notified bodies – June 2024
This document aims to provide guidance to the authorities responsible for notified bodies (hereafter, the Designating Authorities) and joint assessment teams (JATs) when conducting: − assessments of conformity assessments bodies (CABs) that apply for designation as a...
Novas regras de transparência do CTIS entrarão em vigor a 18 de junho
www.infarmed.pt No dia 18 de junho entrarão em vigor as novas regras de transparência da base de dados europeia de ensaios clínicos CTIS (Clinical Trials Information System), juntamente com a atualização do portal público do CTIS. Até agora, foi publicada toda...
The revised transparency rules for the Clinical Trials Information System (CTIS) will become applicable on 18 June 2024
The revised transparency rules for the Clinical Trials Information System (CTIS) will become applicable on 18 June 2024, with the launch of a new version of the CTIS public portal . The updated rules strike a balance between transparency of information and protection...
Aprovação, Formação e Revisão anual de PREÇOS de MEDICAMENTOS: ” uma formação muito elucidativa , com exposição de bons exemplos práticos. “
Decorreu com sucesso mais uma eição da formação 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 Medicamentos...
Relatório | Sistema Nacional de Farmacovigilância | 2023
O INFARMED, I.P. divulga o relatório de atividades do Sistema Nacional de Farmacovigilância correspondente ao ano de 2023. Até ao final de 2023, o Portal de notificação de RAM (Portal RAM) registou cerca de 155.497 notificações de suspeitas de reações adversas a...
EU Health data centre and a common data strategy for public health
Regarding health data, its availability and comparability, the Covid-19 pandemic revealed that the EU has no clear health data architecture. The lack of harmonisation in these practices and the absence of an EU-level centre for data analysis and use to support a...
Study supporting the monitoring of the availability of medical devices on the EU market (MD Availability)
Medical devices (MD) and in vitro diagnostic medical devices (IVD) are essential for a working healthcare system and have a crucial role to play in the prevention, diagnosis, monitoring, prediction, prognosis and treatment of acute and chronic illness and diseases as...
COMMISSION IMPLEMENTING DECISION amending Implementing Decision C(2021) 2406 on a standardisation request to the European Committee for Standardization and the European Committee for Electrotechnical Standardization as regards medical devices
The second amendment to the MDR/IVDR standardisation request M/575 has been adopted on 27 May 2024 as "COMMISSION IMPLEMENTING DECISION amending Implementing Decision C(2021) 2406 on a standardisation request to the European Committee for Standardization and the...
ICH M14 guideline on general principles on plan, design and analysis of pharmacoepidemiological studies that utilize real-world data for safety assessment of medicines – Scientific guideline
The use of pharmacoepidemiological studies as a source of evidence for regulatory decision-making has increased globally, and multiple guidelines and best practice documents have been developed by health authorities and professional societies. Generation of robust...
Annual report highlights progress in science, medicines and health in 2023
30 May 2024 EMA publishes 2023 annual report EMA’s annual report 2023 published today details the Agency’s contributions to public and animal health in the European Union (EU). With a fresh layout and new interactive features, the report offers insights into EMA's...
Medical devices: Council adopts new measures to help prevent shortages
The Council has adopted new rules updating the law on medical devices in order to help prevent shortages and ease the transition to greater transparency and access to information. The regulation adopted today amends the legislation on medical devices, including...
New data demonstrates the value of regulatory data protection (RDP), and its impact on European competitiveness and patient access to medicines
PUBLISHE BY EFPIA.EU For innovative health and life science companies, European competitiveness being at the forefront of the agenda in Brussels and beyond could help reverse the loss of cutting-edge science and investment to other parts of the world. The...
COST AND VALUE OF REGULATORY DATA PROTECTION
The European Union (EU) General Pharmaceutical Legislation (GPL) lays down provisions related to medicinal products authorisation and post-authorisation requirements, preauthorisation support schemes, regulatory incentives in terms of data and market protection,...
Europe – MDCG 2022-4 Rev 2 Guidance on appropriate surveillance regarding the transitional provisions under Article 120 of the MDR with regard to devices covered by certificates according to the MDD or the AIMDD
Article 120 of the Medical Device Regulation (EU) 2017/745 (MDR), as amended by Regulation (EU) 2023/6071, states that devices which are covered by valid certificates issued by a notified body under the Active Implantable Medical Devices Directive 90/385/EEC (AIMDD)...
AUTOINSPEÇÕES ao Sistema GDP: ” A formação foi muito boa, com aquisição de conhecimentos essenciais e com ótima aplicabilidade prática
Decorreu na passada quarta-feira, dia 23 de maio , uma nova edição da formação exclusiva da Formiventos AUTOINSPEÇÕES / AUDITORIA INTERNA ao Sistema GDP, conduzida por Sónia Rei , Diretora Técnica da Hikma Farmacêutica (Portugal) Nesta formação foram analisados em...
First implementing regulation ((EU) 2024/1381) by the European Commission pursuant to the HTA Regulation ((EU) 2021/2282)
The Heads of HTA Agencies Group (HAG) welcomes the adoption of the first implementing regulation ((EU) 2024/1381) by the European Commission pursuant to the HTA Regulation ((EU) 2021/2282). 📌 This implementing regulation is a major milestone in the...
COSMETIC CONTENT WRITING : ” Evento muito produtivo . Os casos práticos foram , sem dúvida, uma mais valia
No dia 23 de maio decorreu a formação COSMETIC CONTENT WRITING & ALEGAÇOES DE SUSTENTABILIDADE, bajo o lema : Técnicas para escrita e Best Practices para comunicação de alegações em produtos cosméticos com foco em conceitos de sustentabilidade Uma...
TRS 1052 – Annex 2: WHO good manufacturing practices for excipients used in pharmaceutical products
This document provides information on GMP that should be implemented to assist manufacturers to produce and control excipients used in pharmaceutical products that will meet their intended specifications, in a consistent manner. Risk assessment may be useful in...
Boas Práticas de Fabrico de Canábis Medicinal : “Excelente formação”
“Excelente formação. A formadora apresenta um elevado grau de conhecimento no tema e explicações muito claras. “ IBERFAR Realizou-se na quarta-feira passada mais uma edição da formação sobre as BOAS PRÁTICAS DE FABRICO DE CANÁBIS MEDICINAL , bajo o lema : Uma...
8th notified bodies survey on certifications and applications (MDR/IVDR)
Survey results of the 8th NB survey with data status 29 February 2024 (small and medium dataset) This document was produced in the frame of the SC 2021 P3 03 under the DG SANTE Framework contract (FWC SANTE/2021/OP/0002) for evaluation, impact...
FDA GUIDANCE: Remanufacturing of Medical Devices
Medical devices encompass a vast array of products with different technologies, product lifecycles, complexity, intended users, and environments of use. Many devices are reusable and need preventive maintenance and repair during their useful life. For these devices,...
New guidance for medical devices used in combination with medicines
A new revision of the guidance available to applicants, marketing authorisation holders and notified bodies of medical devices has been published today. This question-and-answer document provides practical considerations on the implementation of the medical devices...
Commission presents a new project that looks at combined studies
In a report published today, the Commission, the national authorities, ethics committees, the European Medicines Agency and stakeholders analyse the current challenges faced when conducting combined studies and possible ways forward to streamline the regulatory...
Post MA Lifecycle Management : ” Formação extremamente interessante”
Os profissionais dos Assuntos Regulamentares devem ser muito proativos no desenho da estratégia e planeamento do ciclo de vida dos produtos, criando dossiers de elevada qualidade técnica, avaliando se as alterações necessitam ou não de autorização, quando devem ser...
Questions & Answers for applicants, marketing authorisation holders of medicinal products and notified bodies with respect to the implementation of the Regulations on medical devices and in vitro diagnostic medical devices (Regulations (EU) 2017/745 and (EU) 2017/746)
This Question and Answer (Q&A) document provides practical considerations concerning the implementation of the medical devices and the in vitro diagnostic medical devices regulations in the context of combinations of medicinal products with medical devices. This...
CTD MÓDULO 3 :Formação muito completa , clara e objetiva , com exemplos práticos para melhor compreensão dos conteúdos
Mais uma edição da formação CTD MODULO 3, conduzida por Pedro Fins Pereira, Regulatory Affairs Officer da Viatris; que destacou-se pela excelência e a qualidade , com uma apresentação bem estruturada e de forma concisa. A ligação entre a teoria e os casos práticos...
New version of EUDAMED user guide UDI Devices
The new version of EUDAMED 3.8.0 has been deployed. Release note 2024-05-15 Release notev 3.8.0
Commission presents a new project that looks at combined studies. COMBINE CTR-IVDR-MDR . ANALYSIS PHASE REPORT
In a report published today, the Commission, the national authorities, ethics committees, the European Medicines Agency and stakeholders analyse the current challenges faced when conducting combined studies and possible ways forward to streamline the regulatory...
OECD – OCDE issued a report on artificial intelligence in health
The AI Age is here and here to stay The OECD has been at the frontier in defining comprehensive policy principles for trustworthy development and use of Artificial Intelligence (AI) with its 2019 Principles. These principles seek to mitigate some of AI’s most...
FDA Guidance Remanufacturing of Medical Devices
Because of the apparent confusion between servicing and remanufacturing, FDA committed in the FDA Report on Device Servicing to issue guidance that clarifies the difference between servicing and remanufacturing activities. To assist with this clarification, FDA...
Formação BPD de MEDICAMENTOS : Formação muito completa , com vários exemplos de casos práticos “
Nos dias 7 e 8 de maio, decorreu mais uma edição da formação sobre as BOAS PRÁTICAS de DISTRIBUIÇÃO de medicamentos de uso humano e substâncias ativas conduzida pela Dra Sónia Rei,Diretora Técnica, da Hikma Farmacêutica (Portugal) Evento muito enriquecedor ,...
MASTER COURSE SUPLEMENTOS ALIMENTARES : “Excelente formação com muito conhecimento técnico e aplicabilidade no dia-a-dia.”
Decorreu mais uma edição do MASTER COURSE Autorização, publicidade e comercialização de SUPLEMENTOS ALIMENTARES, uma formação muito interessante, onde foram discutidos temas muito relevantes para a prática diária de quem trabalha com suplementos alimentares ...
MSSG – Recomendações para robustecer as cadeias de abastecimento de medicamentos críticos
O Grupo Diretor Executivo sobre Ruturas e Segurança dos Medicamentos (GDRM) divulgou um conjunto de medidas que poderão ser adotadas, casuisticamente, para garantir a segurança do abastecimento dos medicamentos incluídos na lista europeia de medicamentos críticos....
Impact of AI on the regulation of medical products. Implementing the AI White Paper principles
The Medicines and Healthcare products Regulatory Agency (MHRA) is the independent regulator of medicines, medical devices and blood components for transfusion in the UK. We operate in a statutory framework set by HM Government. Our responsibilities are to; ensure...
Essential Principles of Safety and Performance of Medical Devices and IVD Medical Devices
This document applies to all medical devices and IVD medical devices and is intended to identify and describe essential principles of safety and performance which should be considered during the design and manufacturing process. Depending on the particular medical...
Medical Device Regulatory Review Report: Guidance Regarding Information to be Included
The scope of this guidance document is limited to the information participating IMDRF Regulatory Authorities require in medical device regulatory review reports, the format of reports, and the information necessary for participating IMDRF RAs to effectively use the...
Principles of Labeling for Medical Devices and IVD Medical Devices
This document applies to all medical devices, including IVD medical devices, and is intended to specify the general content and format of medical device and IVD medical device labeling in paper or electronic format. This document provides general labeling principles,...
Commission welcomes adoption by European Parliament of measures to improve the availability of in vitro diagnostics
The Commission welcomes the adoption by the European Parliament today of measures, proposed by the Commission in January 2024, to improve the availability of in vitro diagnostics (IVDs) for patients and healthcare providers. These measures include granting more...
Artificial intelligence and cybersecurity
Artificial intelligence (AI), which is being integrated into our daily lives at an overwhelming pace, has the potential to shape our digital landscape. As it can influence everything – from personal data security to national defence strategies – the issue of...