NOTICIAS
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...
New recommendations to strengthen supply chains of critical medicines
These recommendations have been developed by EMA’s Medicines Shortages Steering Group (MSSG) and will facilitate the availability and supply of critical human medicines for which vulnerabilities in the supply chain have been identified. Measures considered by the MSSG...
FDA Data Standards Catalog
FDA GUIDANCE DOCUMENT Data Standards Catalog. APRIL 2024
Real-world evidence provided by EMA
EMA publishes new guidance on real-world evidence generation service The use of Real-World Data (RWD) is increasingly embedded in the scientific evaluation of human medicines. At the European Medicines Agency, the Real-World Evidence Team (TDA-RWE) of the Data...
Implementing the European Health Data Space Across Europe
Highlights from the report Here’s a preview of some of our key findings across the six implementation dimensions: governance, capacity and skills, resources and funding, data quality, the relationship between primary and secondary data, and the creation of a...
Good agricultural and collection practice for starting materials of herbal origin – Scientific guideline
This guideline on Good Agricultural and Collection Practice (GACP) for starting materials of herbal origin came into effect in August 2006 and is intended to provide guidance to ensure appropriate and consistent quality of herbal substances . The current Revision 1 of...
Guidance on content of the Investigator’s Brochure for clinical investigations of medical devices
The IB shall contain the clinical and non-clinical information on the investigational device that is relevant for the investigation and available at the time of application. The information shall be presented in a concise, simple, objective, balanced, and...
Successful and timely uptake of artificial intelligence in science in the EU
Artificial Intelligence (AI) technologies are one of the most disruptive general purpose applications at the service of research and innovation. It acts as a catalyst for scientific breakthroughs and is rapidly becoming a key instrument in the scientific process in...
MDCG 2022-9 / Rev.1 Summary of safety and performance Template
Regulation (EU) 2017/746 on in vitro diagnostic medical devices (the IVDR) requires that the manufacturer shall draw up a summary of safety and performance (SSP) for class C and D devices, other than devices for performance studies. The SSP shall be validated by a...
MDCG 2024-4 Safety reporting in performance studies of in vitro diagnostic medical devices under Regulation (EU) 2017/746
Safety reporting in performance studies of in vitro diagnostic medical devices (IVDs) shall be performed in line with the requirements of Article 76(2) of Regulation (EU) 2017/746 – In Vitro Diagnostic Medical Device Regulation (IVDR): The sponsor shall report without...
PROMOTIONAL REVIEW de SUPLEMENTOS ALIMENTARES: “Excelente sessão muito interativa.”
Decorreu na passada quinta-feira, dia 11 de abril , a segunda edição do workshop : " PROMOTIONAL REVIEW de SUPLEMENTOS ALIMENTARES"; uma sessão com o objetivo de efectuar uma revisão exaustiva sobre os pontos críticos da rotulagem e publicidade de Suplementos...
Study on the implementation of Article 17 of Regulation (EU) 2017/745 on medical devices on the EU market
Article 17 of Regulation (EU) 2017/745 (Medical Device Regulation – MDR) regulates the reprocessing of single-use devices (SUDs) with relevance for the European Economic Area (EEA) which may only take place where permitted by national law and in accordance with this...
PUBLICIDADE de MEDICAMENTOS: “Muito interativo e participativo.”
Realizou-se na terça-feira passada a formação sobre PUBLICIDADE de MEDICAMENTOS, bajo o lema "Como garantir a compliance nas atividades de Marketing e vendas , e best practices para mitigar os riscos de não compliance." Nesta formação, conduzida por Sónia Ferreira,...
Abbreviations and pictograms common throughout the Union to be used on the packaging of veterinary medicinal products
The abbreviations and pictograms set out in the Annexes to this Regulation may be used to replace the written information required on the labelling of immediate packaging and on the outer packaging of veterinary medicinal products referred to in Article 10(1) and...
Decreto-Lei n.º 29/2024, de 5 de abril, relativo aos dispositivos médicos.
Novo Decreto-Lei n.º 29/2024 publicado 5 de abril! O mesmo visa assegura a execução, na ordem jurídica interna, do Regulamento (UE) 2017/745, relativo aos dispositivos médicos. O presente decreto-lei assegura a execução, na ordem jurídica interna, do...
Qualificação de FORNECEDORES GMP: ” “Boa formação para sedimentar conhecimentos. Formação com grande interação entre participantes e formadora. “
No dia 4 de abril decorreu mais uma edição da formação Qualificação de FORNECEDORES ,Clientes e Entidades Subcontratadas no âmbito das BOAS PRÁTICAS DE FABRICO oferecendo aos participantes uma análise pormenorizada do processo de qualificação de fornecedores e...
Despacho n.º 3637/2024, que determina a adoção do sistema de rotulagem nutricional simplificado Nutri-Score
Em Portugal, na ausência de determinação de um sistema específico de rotulagem, alguns operadores económicos têm vindo a adotar diferentes sistemas de rotulagem simplificada, o que pode dificultar ou confundir os consumidores no momento da sua escolha e permitir a...
New GMP Auditors Reference Handbook
The ECA GMP Auditor Association has published the first 4 draft chapters of the new GMP Auditors Reference Handbook. You can access the draft chapters after free registration here https://lnkd.in/erX69ZeH
FDA Guidance for Industry :Data Integrity for In Vivo Bioavailability and Bioequivalence Studies
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled “Data Integrity for In Vivo Bioavailability and Bioequivalence Studies.” The purpose of this guidance is to provide recommendations to applicants...
Providing Regulatory Submissions in Electronic Format: IND Safety Reports Guidance for Industry
FDA is announcing the availability of a final guidance for industry entitled “Providing Regulatory Submissions in Electronic Format: IND Safety Reports.” This guidance finalizes the draft guidance of the same name published on October 30, 2019 (84 FR 58158), and...
ICH guideline update: ICH Q2 -Validation of Analytical Procedures has been updated (Revised)
This guidance applies to analytical procedures used for release and stability testing of commercial drug substances and products, hereafter referred to as products. The guidance can also be applied to other analytical procedures used as part of the control strategy...
IMPORTAÇÃO/ EXPORTAÇÃO de MEDICAMENTOS de uso humano; mais uma formação de grande relevância para os participantes
Realizou-se no dia 20 de março a primeira edição da formação exclusiva da Formiventos IMPORTAÇÃO/ EXPORTAÇÃO de MEDICAMENTOS de uso humano, como foco nas Responsabilidades do DIRETOR TÉCNICO no âmbito do proceso de importação/exportação de medicamentos...
Medical technology industry perspective on the final AI Act
In response to the European Parliament Plenary endorsement of the AI Act, MedTech Europe would like to present a medical technology industry perspective on the final agreed text of the AI Act. We welcome the significant efforts made by the co-legislators to reduce...
Best practices guide for managing suppliers of API manufacturers Version 2, 18 March 2024
This document's objective is to provide guidance and suggest a harmonized approach within the API industry on how to manage suppliers of materials and services in an adequate and compliant manner. The intention is to establish a supplier management framework that is...
Handling and Retention of Bioavailability BA and Bioequivalence BE Testing Samples
FDA JUST RELEASED : Handling and Retention of BA and BE Testing Samples Guidance for Industry This guidance is intended to provide recommendations for applicants of new drug applications (NDAs) and abbreviated new drug applications (ANDAs), including supplemental...
Visão global da área dos ESTUDOS DE ESTABILIDADE : ” Temas abordados pertinentes e expostos de forma clara “
No dia 20 de março decorreu a primeira edição da formação sobre os Pontos chave do desenho e otimização de ESTUDOS DE ESTABILIDADE bajo o lema "Como realizar estudos de estabilidade apropriados, como economizar recursos, e melhorar a probabilidade de aprovação...