NOTICIAS

The purpose of this new harmonised guideline is to introduce the clinical protocol template and the technical specification to ensure that protocols are prepared in a consistent fashion and provided in a harmonised data exchange format acceptable to the regulatory...

The European Data Protection Board (EDPB) has adopted Guidelines 02/2024 (Version 2.0) on Article 48 of the GDPR. The purpose of these guidelines is to clarify the rationale and objective of Article 48 GDPR, including its interaction with the other provisions of...

Decorreu no dia 4 de junho a formação IMPORTAÇÃO/ EXPORTAÇÃO de MEDICAMENTOS de uso humano, bajo o lema " Responsabilidades do DIRETOR TÉCNICO no âmbito do proceso de importação/exportação de medicamentos relativamente  à regulamentação aplicável, procedimentos,...

An owner or operator of an establishment who is engaged in the manufacture, preparation, propagation, compounding, assembly, or processing of a device intended for human use is generally required to register the establishment and submit listing information for all...

Manufacturers operating under the (EU) 2017/745 Medical Device Regulation (MDR) and (EU) 2017/746 In Vitro Diagnostic Regulation (IVDR) are required to utilise the European Medical Device Nomenclature (EMDN) for regulatory submissions, device registration in EUDAMED,...

The ICH M4Q(R2) draft Guideline “The Common Technical Document (CTD) for the Registration of Pharmaceuticals for Human Use: Quality” was endorsed by the ICH Assembly (at Step 2a/b of the ICH process) at the Madrid meeting in May 2025.   This multidisciplinary...

The EU Startup and Scaleup Strategy aims to make Europe the best place in the world to launch and grow global technology-driven companies, including deep tech companies. It focuses on helping innovators, founders and investors to Choose Europe! by improving the...

No dia 28 de maio decorreu a  formação sobre DISPOSITIVOS MÉDICOS : O MUST-KNOW REGULAMENTAR PARA UM OPERADOR EUROPEU, conducida por José Malta, Farmacêutico | Especialista em Assuntos Regulamentares, na ALL4COMPLIANCE – Freelance Fit-to-Need Consultancy A formação...

Conduzido pela experiente profissional Dra Helena Vieira, Directora Técnica e de Assuntos Regulamentares da APARD ,esta nova  edição do master course  Autorização, publicidade e comercialização de SUPLEMENTOS ALIMENTARES: decorreu com sucesso na semana passada ....

The newly published ISO/FDIS 10993-1 brings major changes that will significantly impact how medical device manufacturers approach biological evaluations. These updates go beyond technical tweaks—they reshape the entire framework with a stronger focus on risk...

The types of Q-Subs covered by this guidance in detail are listed in Sections II.A-E of this guidance. Some other submission types are noted solely to indicate that they are tracked with a “Q” number and should be submitted following the processes for Q-Subs, while...

No passado 27 de maio, decorreu em Lisboa a sessão formativa sobre TECH TRANSFER  conduzida por Marina Costa, Regulatory Affairs Manager na The Force CT GmbH Esta formação abordou a transferência de tecnologia sob a ótica dos assuntos regulamentares, destacando...

The assessment report of the CHMP’s Article 5(3) of Regulation (EC) No 726/2004 opinion on nitrosamine impurities in human medicinal products provides general guidance and recommendations on mitigating and preventing the presence of nitrosamines in human medicinal...

No dia 27 de maio decorreu a edição 2025 da formação sobre Como implementar, rever e avaliar CAPAs O workshop , conduzido por Marta Monteiro, reconhecida especialista na indústria,  apresentou os conceitos e ferramentas para a criação de um processo estruturado e...

MedTech Europe has published a new leaflet outlining four urgent targeted measures to support an effective implementation of the Medical Devices Regulation (EU) 2017/745 (MDR) and the In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746 (IVDR). The four...

Realizou-se na terça-feira passada a formação  VALIDAÇÃO DE SISTEMAS INFORMÁTICOS, uma formação específica para atualizar os conhecimentos e competências sobre o processo de CSV, tendo em consideração as guidelines de qualidade cGMP e/ou outras aplicáveis : -Análise...

Teve lugar no dia  20 de maio uma nova  edição da formação exclusiva da Formiventos sobre PROMOTIONAL REVIEW COMPLIANCE & BEST PRACTICES   conduzida pela especialista Dra Sónia  Ferreira, Technical Director, RA Manager/ LRPPV Quality Manager, na GUERBET. A....

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...

The International Pharmaceutical Excipients Council Federation, (IPEC Federation) announces the availability of the revised IPEC Incorporation of Pharmaceutical Excipients into Product Development using Quality-by-Design (QbD) (Version 2, 2025). The guide was first...

The International Council for Harmonisation (ICH) has published the draft M4Q(R2) Guideline: The Common Technical Document for the Registration of Pharmaceuticals for Human Use – Quality The draft M4Q(R2) guideline introduces a modernized structure and enhanced...

No passado 22 de maio teve lugar a formação  BOAS PRÁTICAS DE FABRICO de PRODUTOS COSMÉTICOS. Nível avançado  conduzida por Daniel Ribeiro, Operations Manager na Pharmilab Uma formação avançada, que combina a norma ISO 22716:2007 com casos práticos, para atualizar e...

  A World Health Organization (Organização Mundial da Saúde) acaba de lançar as "Orientações das Melhores Práticas para Ensaios Clínicos", com recomendações práticas para tornar os ensaios clínicos mais eficientes, éticos e inclusivos.

No passado 21 de maio  decorreu em Lisboa a formação prática sobre o PLANO de GARANTIA DE ABASTECIMENTO, conduzida por Sónia Rei, Diretora Técnica na Hikma Farmacêutica (Portugal) Recohecendo a relevância do cumprimento das novas obrigações dos TAIMS de elaborar e...

The European Commission’s Directorate-General for Health and Food Safety (DG SANTE) - through the European Health and Digital Executive Agency (HaDEA) - has commissioned a “Study supporting the monitoring of availability of medical devices on the EU market”. The study...

The International Medical Device Regulators Forum (IMDRF) has released its updated Standard Operating Procedures (IMDRF/MC/N2FINAL:2025, Edition 13 Version 2). This critical document lays out the framework for how international medical device regulatory convergence is...

On 13 May 2025, the European Commission adopted Regulation (EU) 2025/877, amending the Cosmetic Products Regulation., and strengthening the safety of cosmetics by banning certain CMR (carcinogenic, mutagenic, or toxic for reproduction) substances. The regulation is...

The Council for International Organizations of Medical Sciences (CIOMS) has issued a draft report detailing a set of best practices to guide the integration of artificial intelligence in pharmacovigilance (PV) activities.   The report highlights that a crucial...

The EU AI Office just published its AI Literacy - Questions & Answers.

ICH M13B Guideline is intended to provide recommendations (BE) studies for one or more additional strengths of a drug product in an application where in vivo BE has been demonstrated for at least one of the strengths. The guideline is applicable during both...

The European Medicines Agency (EMA) has published a concept paper (EMA/INS/GMP/48771/2025) outlining proposed revisions to Part IV of the GMP guidelines specific to Advanced Therapy Medicinal Products (ATMPs). This revision aims to bring ATMP GMP guidance in line with...

Nos  días 6 e 7 de maio  decorreu a edição nº 23 da formação mais sólida e relevante no mercado portugues sobre as BOAS PRÁTICAS de DISTRIBUIÇÃO de MEDICAMENTOS e substâncias ativas. Uma formação essencial para todos os profissionais com atividades GDP , que abrange...

Team-NB has released Version 3 of its Position Paper on the submission of technical documentation according to Annex II and III of the Medical Device Regulation (EU) 2017/745. 📄 Explore the full Position Paper: https://lnkd.in/d3iSj4va

EMA and the Heads of Medicines Agencies (HMA) have published a joint workplan "Data and AI in medicines regulation to 2028". It sets out how the European medicines regulatory network plans to leverage large volumes of regulatory and health data as well as new tools to...

The European Medicines Agency (EMA) has published an updated guidance on Product Management Service (PMS) - Implementation of International Organization for Standardization (ISO) standards for the identification of medicinal products (IDMP) in Europe. The guidance has...

A new revision of the Manufacturer Incident Report Form has been published. Manufacturers have till November 2025 to implement this revision in their system: https://lnkd.in/dAZ3XSZx

FDA’s generic drug Science and Research Program, created under the Generic Drug User Fee Amendments (GDUFA), is an essential component of FDA’s mission to protect and promote public health. The Science and Research Program is implemented through extensive research...

This reflection paper describes components to be put in place to realise an EU-wide solution in which  ePI could be easily accessed by citizens wherever they are in Europe, in their preferred language when  available. It calls on stakeholders to take action and invest...

Published by AT - Autoridade Tributária e Aduaneira. 2025   Portugal has implemented the Tax Incentive for Scientific Research and Innovation (IFICI). This scheme aims to attract talent , to promote scientific research  and innovation in the country. The...

This document contains the details of how Legacy Devices are identified in EUDAMED and how you can register a Legacy Device in EUDAMED   EUDAMED user guide Legacy Devices registration Playground v 3.11.0 2025

Regulation (EU) 2017/745 on medical devices and Regulation (EU) 2017/746 on in vitro diagnostic medical devices introduce an EU identification system for medical devices based on a Unique Device Identifier (UDI). The UDI-DI/Device module of EUDAMED is used for the...

According to the Medical Devices legislation, Old and custom-made devices (OCM) are not to be registered in the UDI/Devices module but are to be referenced in Vigilance reports. Old Device: Devices placed on the market according to the medical devices Directives or...

For the current EUDAMED Playground release, the following types of reports can be managed: • MIR (Manufacturer Serious Incident Report) • FSCA (Field Safety Corrective Action) • PSUR (Periodic Safety Update Report) • NCAR (National Competent Authority Report) • MTR...

    EUDAMED user guide .Market Surveillance Playground v 3.11.0 2025

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...

Team-NB members adopted, at the unanimity of the presents, a paper prepared by the 30 members of the task force with the aim to provide an overview of the Team-NB perspective on the challenges of the AI Act with particular attention to its implementation....

Team-NB members adopted, at the unanimity of the presents, a common paper aimed at describing in detail the pre-application and application and Post application phases processes through which manufacturers may apply to Notified Bodies (NBs) for the certification of...

  The following guideline outlines the stability data expectations for drug substances and drug products. This guideline is applicable to marketed drug products, including those associated with registration and lifecycle/post-approval changes and, when...

" Foi enriquecedora e bem estruturada. Os conteúdos abordados foram pertinentes e aplicativos à prática, proporcionando uma visão clara dos princípios e requisitos essenciais . Uma experiência  muito recomendável para quem deseja aprofundar os seus conhecimentos sobre...

“Foi uma formação muito esclarecedora, quer pela informação fornecida, quer pelos exemplos de apoio e principalmente pela troca de experiência entre colegas e formador. “ GROVIDA   No dia 3 de abril realizou-se  a 8 ª edição da formação GMP CANÁBIS : Visão...

Discussions about potential solutions addressing respective evidence needs to support decision making across the life cycle must acknowledge the difference in scopes between marketing authorisation, including potential orphan maintenance applications as applicable,...

  “Gostei da integração dos exercícios com a informação teórica. O facto da grupa ser pequeno foi propício a muita comunicação entre as partes. Formadora muito acessível e eloquente . “ DAIICHISANKYO   Dando seguimento ao sucesso das anteriores edições , no ...