NOTICIAS

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...

This guideline presents elements for consideration during the validation of analytical procedures included as part of registration applications. Analytical procedure validation forms a part of the analytical procedure lifecycle, as described within ICH Q14 Analytical...

  Decorreu mais um workshop prático  sobre  NOTIFICAÇÃO E ALEGAÇÕES de SUPLEMENTOS ALIMENTARES  com exemplos práticos Usando uma combinação de teoria e exercícios práticos, a formadora , Rita Dias, Especialista em Registo e introdução no mercado de suplementos...

Today, the European Commission launched an online public consultation on the draft Implementing Act on Joint Clinical Assessments of Medicinal Products. This online consultation remains open for responses until 2 April 2024. We invite all interested individuals and...

O cumprimento das obrigações previstas para a comercialização dos medicamentos em consonância com as normas em vigor é uma responsabilidade partilhada entre todos os agentes do circuito, sendo inadmissíveis situações que possam colocar problemas no abastecimento do...

  This guideline describes science and risk-based approaches for developing and maintaining analytical procedures suitable for the assessment of the quality of drug substances and drug products. It applies to new or revised analytical procedures used for release...

The ICH Q3C(R9) “Guideline for Residual Solvents” was revised using the ICH Minor Revision Procedure and reached Step 4 of the ICH Process on 24 January 2024. This minor revision was implemented to include consideration of solvent volatility for analytical methods....

Ontem, tivemos o prazer de realizar uma nova edição da formação exclusiva da FORMIVENTOS  sobre as BOAS PRÁTICAS DE DISTRIBUIÇÃO , NÍVEL AVANÇADO, bajo o lema " uma formação de refreshing  nas Boas Práticas de Distribuição de Medicamentos, à luz da formacão contínua...

“A formação representa um overview completo e claro do processo CAPA. “  GRUNENTHAL   Decorreu no dia 21 de fevereiro a 3ª edição da formação exclusiva da Formiventos sobre : Como implementar, manter e rever o Sistema CAPA, conduzido por Marta Monteiro , Global...

The Council has endorsed key updates to the law on medical devices that will help prevent shortages and ease the transition to greater transparency and access to information. The regulation approved by EU member-state representatives today amends the legislation on...

This guidance addresses frequently asked questions related to the implementation of FDA’s regulation on charging for investigational drugs under an investigational new drug application (IND) for the purpose of either clinical trials or expanded access for treatment...

The Food and Drug Administration (FDA, the Agency, or we) is issuing a final rule to amend the device current good manufacturing practice (CGMP) requirements of the Quality System (QS) regulation to harmonize and modernize the regulation. We are harmonizing to align...

  EUDAMED is the IT system developed by the European Commission to implement the EU medical devices regulations: Regulation 2017/745 on medical devices Regulation 2017/746 on in vitro diagnosis devices EUDAMED is structured around six interconnected modules and a...

Com a publicação do Decreto-Lei n.º 128/2023, de 26 de dezembro, foi aprovada a retirada do preço das embalagens dos medicamentos que estava prevista no Decreto-Lei n.º 176/2006, de 30 de agosto, na sua redação atual, mantendo-se, porém, a obrigação de, no momento da...

15 February 2024 EMA and the Heads of Medicines Agencies (HMA) have launched two public electronic catalogues: one for real-world data (RWD) sources and one forWD studies. The catalogues help medicines regulators, researchers and pharmaceutical companies to identify...

TGA have been published new document very helpful and interesting about EU MDR Transition –Recalls and market notifications Case studies and scenarios Version2.1,February2024   Introduction This guidance covers case studies and scenarios about recalls and market...

ICH JUST RELEASED ‼️ It is important to establish an internationally standardised procedure to ensure the quality of post3 approval safety information and to harmonise, where feasible, the way of gathering and reporting information. The ICH E2D guideline...

The new monograph on Cannabis flower (3028) was adopted at the 176th session of the European Pharmacopoeia (Ph. Eur.) Commission held on 20 and 21 June 2023. Given the exceptionally high interest from stakeholders in having access to the new text as soon as possible,...

This guidance is intended to assist sponsors of clinical trials in determining when a data monitoring committee (DMC) (also known as a data and safety monitoring board (DSMB), a data and safety monitoring committee (DSMC), or an independent data monitoring committee...

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled “Conducting Remote Regulatory Assessments--Question and Answers.” FDA is issuing the draft guidance to describe the Agency’s current thinking...

  Version 5, 7 February 2024 -- This glossary combines the terms and definitions included in the guidelines of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). It was compiled by CIOMS from the...

O dia 31 de janeiro de 2024, marca os dois anos de entrada em aplicação do Regulamento Europeu de Ensaios Clínicos (CTR), e do lançamento do Sistema de Informação de Ensaios Clínicos (CTIS). Assinala-se o aproximar do fim do período de transição para CTR/CTIS dos...

The medtech industry posted an uneven year in 2023. Among the reasons for celebration were expectation-beating revenue growth, a record number of novel-product approvals, and a spate of divestitures that helped companies refocus on their core capabilities.   On...

  NB NEWS: The results of the 6th Notified Bodies Survey on certifications and applications (MDR/IVDR) have just been published 5 Febuary 2024.

The European Medical Device Nomenclature (EMDN), as established by Article 26 of Regulation (EU) 2017/745 – Medical Device Regulation (MDR) and Article 23 of Regulation (EU) 2017/746 - In Vitro Diagnostic medical devices Regulation (IVDR), will be annually reviewed...

A large release of the Medical Device Coordination Group (MDCG) Guidance on Vigilance has been published to the European Commission website: MDCG 2024-1, MDCG 2024-1-1, MDCG 2024-1-2, MDCG 2024-1-3, and MDCG 2024-1-4. Each guidance falls into the “Device Specific...

From 1 January 2024, the EC Decision Reliance Procedure (ECDRP) will be replaced by the new International Recognition procedure (IRP). The Mutual Recognition/Decentralised Reliance Procedure (MRDCRP) will be incorporated under the umbrella of IRP. ECDRP and MRDCRP...

Consultation open Medical Device Software: Considerations for Device and Risk Characterization Start date Friday, 2 February 2024 Closing date Thursday, 2 May 2024   A Proposed Document by the International Medical Device Regulators Forum (IMDRF), Software as a...

A new perspective on how technology, transformation efforts, and other changes have affected payers, health systems, healthcare services and technology, and pharmacy services   The acute strain from labor shortages, inflation, and endemic COVID-19 on the...

The World Health Organization (WHO) developed the Quality Assurance of Pharmaceuticals Compendium, Volume 2, to ensure the quality, safety and effectiveness of medicines, focusing on good manufacturing practices (GMP) and related guidelines. This summary provides an...

The FDA issued the Quality Management System Regulation (QMSR) Final Rule, which amends the device current good manufacturing practice (CGMP) requirements of the Quality System (QS) regulation (21 CFR Part 820), incorporating the international standard specific for...

This IAF Medical Device Nomenclature document (IAF MDN) is an informative document that was developed for the support of IAF MD8 and MD9. It provides long established medical device names and classifications, where risk classifications do not exist in the Global...

The Commission and Member States have created MDR and IVDR tables. These tables aim to help manufacturers of medical devices and in vitro diagnostic medical devices, particularly small and medium-sized ones, understand the language requirements for the information and...

Update: January 31, 2024 The FDA issued the Quality Management System Regulation (QMSR) Final Rule to amend the device current good manufacturing practice (CGMP) requirements of the Quality System (QS) regulation (21 CFR Part 820), incorporating by reference the...

  Five new mdcg files read the full thread. 1. MDCG 2024-1 Guidance on the vigilance system for CE-marked devices Source: https://lnkd.in/gKC3KPaD 2. MDCG 2024-1-1 DSVG 01 on Cardiac ablation Source: https://lnkd.in/gKM9RuCH 3. MDCG 2024-1-2   Guidance on the...