NOTICIAS

The guideline is intended to address the specific concerns related to the cultivation, harvesting, collection, and primary processing of herbal substances that are used for the preparation of herbal medicinal products. It addresses specific issues associated with...

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...

FDA is announcing the availability of a final guidance for industry entitled “Conducting Remote Regulatory Assessments--Questions and Answers.” The final guidance makes further revisions to and replaces the revised draft guidance entitled “Conducting Remote Regulatory...

The EMA eCTD team and the EU eCTD v4.0 Subject Matter Experts are pleased to announce that a draft EU eCTD v4.0 validation criteria is now available here. The list is a combination of rules existing in eCTD 3.2.2 (adapted to the new standard, where necessary), and new...

At the end of July, The FDA’s Office of Pharmaceutical Quality released a 21-page white paper positioning mature quality practice as both a financial and public-health imperative. Structured in two parts, the analysis first maps a four-stage cost curve (from “minimal”...

The new    COMMISSION IMPLEMENTING REGULATION (EU) 2025/1466 of 22 July 2025,, amending Implementing Regulation (EU) No 520/2012 on the performance of pharmacovigilance activities provided for in Regulation (EC) No 726/2004 of the European Parliament and of the...

The EU medical device regulatory framework (Medical Devices Regulation 2017/745 and In Vitro Diagnostic Medical Devices Regulation 2017/746) is at a pivotal moment. Fragmentation, inefficiencies, and inconsistent application of rules are undermining the goals of...

    8 July 2025 EMA/144509/2025 European Medicines Agency   This report provides an overview of the response of the European Medicines Regulatory Network (EMRN) to the presence of nitrosamine impurities in human medicines. Following the discovery in...

As outcome of an EudraVigilance audit performed by the European Data Protection Supervisor (EDPS) in the context of pseudonymisation procedures and personal data masking, the EDPS recommended to the Agency to adopt, together with the joint controllers (European...

The European Medicines Agency (EMA) publishes information on human medicinal products at various stages of their life cycle, from the early developmental stages through to EMA’s evaluation of authorisation applications, post-authorisation changes, safety reviews and...

In June 2025, the FDA released a white paper emphasizing the need for stronger cybersecurity in medical product manufacturing, specifically focusing on Operational Technology (OT). The paper, titled "Securing Technology and Equipment (Operational Technology) Used for...

  The European Medicines Agency (EMA) has published Version 6.0 of the Sponsor Handbook: CTIS User Guidance on the Sponsor’s Workspace (EMA/186412/2021). This comprehensive update supports sponsors in navigating the Clinical Trial Information System (CTIS),...

We’re proud to share the latest progress in integrating Real-World Evidence (RWE) into regulatory decision-making; 3rd report on the experience gained with regulator-led studies from February 2024 to February 2025, aligned with the EMRN Strategy to 2028 and in...

EU Commission Decision Update! (Expert Panels – Medical Devices) The European Commission has published Implementing Decision (EU) 2025/1324, amending Decision (EU) 2019/1396, introducing changes to the governance and scope of expert panels under the Medical Devices...

.. The European Commission has launched EUDAMED v2.15.0

EUROPE’S LIFE SCIENCES OPPORTUNITY: A STRATEGIC VISION FOR GLOBAL LEADERSHIP COMMUNICATION FROM THE COMMISSION TO THE EUROPEAN PARLIAMENT, THE COUNCIL, THE EUROPEAN ECONOMIC AND SOCIAL COMMITTEE AND THE COMMITTEE OF THE REGIONS Choose Europe for life sciences A...

Code of Conduct for Notified Bodies under Regulations (EU) 2017/745 and (EU) 2017/746 "Improving implementation of the European CE certification of medical devices through the harmonisation of Notified Bodies" Version: 5.1 Date: June 25th 2025 This updated Code of...

Just published: 3rd progress report on the use of real-world evidence (RWE) in medicines regulation (February 2024 - February 2025) Key highlights: 📌 59 RWE studies conducted - nearly 50% more than during the previous reporting period; 📌 DARWIN EU...

On the basis of the New Legislative Framework, as clarified in the Commission notice ‘The “Blue Guide” on the implementation of EU product rules 2022’, the general rule is that more than one legal act of Union harmonisation legislation, such as the MDR and the IVDR...

This document provides FDA’s recommendations to industry regarding cybersecurity device design, labeling, and the documentation that FDA recommends be included in premarket submissions for devices with cybersecurity risk. These recommendations are intended to promote...

This scientific opinion reflects the views of independent experts (MDR Article 106) on the clinical evaluation assessment report (CEAR) of the notified body. The advice is provided in the context of the clinical evaluation consultation procedure (CECP), which is an...

Commission Implementing Regulation (EU) 2021/2226 (2) limits its application to certain medical devices and their accessories. The results of a survey on replacing paper-based instructions for use by electronic instructions for use the Commission carried out from 1...

This document provides a first set of answers, that will be continuously developed and updated, to the most frequently asked questions related to the joint application of the AIA and the MDR or IVDR4 for manufacturers. This Frequently Asked Questions (FAQ) document is...

This document is intended for sponsors of performance studies of in vitro diagnostic medical devices (IVDs) conducted within the scope of the Regulation (EU) 2017/746 (IVDR). It also contains information of relevance to manufacturers providing IVDs for use in...

This document, which primarily targets Medical Device Software (MDSW) manufacturers, provides guidance on: • the criteria for the qualification of software falling within the scope of the Medical Device Regulations , including Medical Device Artificial Intelligence...

EMA’s annual report 2024 published on June 10th, gives insights into the Agency’s strategic priorities and contributions to public and animal health in the European Union (EU). The digital report outlines the most important highlights regarding the evaluation and...

Software Applications (Apps) are significantly changing our way of living, helping in various aspects of our daily lives, including healthcare. Medical device software (MDSW) Apps cover an extensive variety of uses such as those intended to drive insulin pumps, detect...

The European Medical Device Nomenclature (EMDN) is the nomenclature of use by manufacturers when registering their medical devices in the EUDAMED database. Founded on pre-established criteria and requirements and based on orientations provided by the Medical Device...

The new European biotech act, announced in Ursula von der Leyen's political guidelines for 2025, was not included in the Commission work programme published on 11 February, but has recently been announced for early 2026.

This publication seeks to assist organizations with incorporating cybersecurity incident response recommendations and considerations throughout their cybersecurity risk management activities as described by the NIST Cybersecurity Framework (CSF) 2.0. Doing so can help...

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...