NOTICIAS

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...

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 ,...

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  ...

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....

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...

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...

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...

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,...

  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 (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...

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 GUIDANCE DOCUMENT Data Standards Catalog. APRIL 2024

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...

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...

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...

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...

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...

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...

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...

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...

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...

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,...

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...

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...

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...

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...

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

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...

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...

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...

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...

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...

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...

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...

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...

Foi concluída a regulamentação da dispensa de medicamentos em proximidade, estabelecido pelo Decreto-Lei n.º 138/2023, 29 de dezembro. A publicação das portarias n.º 104/2024/1 e n.º 106/2024/1, de 14 de março, confirma o regime legal que permite que os cidadãos...

Decorreu mais uma edição da formação sobre 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 "   Nesta formação foram...

This first version of the Telehealth quality of care tool (‎TQoCT)‎ is intended to be used by Member States (‎namely by focal points for patient safety and quality of care (‎QoC)‎ and all other relevant parties of national telehealth ecosystems)‎ or by individual...

  The guidance aims to assist sponsors in anticipating questions from competent authorities during the assessment of clinical investigation applications and emphasizes the importance of a well-prepared CIP for the successful conduct of the investigation. It...

Artificial intelligence (AI) has the potential to revolutionize health care by advancing medical product development, improving patient care, and augmenting the capabilities of health care practitioners. Aligned with its mission of protecting, promoting, and advancing...

Realizou-se na quinta-feira passada uma nova edição da formação  Gestão de Risco no âmbito das Boas Práticas de Distribuição bajo o lema : " Como aplicar a Gestão de Risco passo a passo: Análise detalhado dos processos de identificação, avaliação , controlo , revisão...

The AMA is committed to ensuring that the evolution of augmented intelligence (AI) in medicine benefits patients, physicians and the health care community by leading the way. This includes: Developing AI principles for the use of AI in health care. Supporting the...

  Decorreu mais uma edição da formação sobre BOAS PRÁTICAS de DISTRIBUIÇÃO de DISPOSITIVOS MEDICOS  uma formação dinâmica, super interessante donde foram abordados os temas de forma prática e concisa e adaptadas às várias realidades . Ao longo das 14 horas de...

  The European Commission has today (13-March) published the updated document of the "Notified Bodies Survey on certifications and applications (MDR/IVDR) survey results of the 6th NB survey with data status 31 October 2023" As a result of further data validation...

The European Commission has just launched an online public consultation on the draft Implementing Act on Joint Clinical Assessments of Medicinal Products. The consultation is to run for four weeks, until April 2. Emphasis on the rules on HTA (Regulation 2021/2282)...

The clinical investigation plan (CIP) shall set out the rationale, objectives, design methodology, monitoring, conduct, record-keeping, and the method of analysis for the clinical investigation. The CIP should be detailed enough to serve as a manual for investigators...

This user manual is part of the official documentation prepared by the European Medicines Agency to support the use of the  EudraVigilanceWebreportingtool (EVWEB). The user manual consists of 5 chapters. Chapter 1 presents a comprehensive overview of the EVWEB...

The undersigned Qualified person responsible for pharmacovigilance (QPPV)/responsible person (RP) declares that he/she: • will keep the username and password provided by the European Medicines Agency (EMA) for the access to the EudraVigilance database under an...

Com o desenvolvimento das redes sociais, a publicidade digital assumiu proporções gigantescas, que exigem especial atenção quando se trata de produtos, como é o caso dos medicamentos, ainda que não dependentes de uma prescrição médica para a sua utilização. Assim, nos...

The European Commission has published two Implementing Decisions regarding medical device harmonised standards. "Implementing Decision (EU) 2024/815 of 6 March 2024 amending Implementing Decision (EU) 2021/1182 as regards harmonised standards for medical gloves for...

    Realizou-se na quarta-feira passada uma nova edição da formação GMP 2024: BOAS PRÁTICAS DE FABRICO ,  especialmente desenhada para profissionais que querem  ampliar e atualizar os seus conhecimentos e saber como melhor cumprir os novos requisitos legais...