NOTICIAS

The European Commission has published Implementing Decision (EU) 2026/2479, introducing an important update to the harmonised standards supporting Regulation (EU) 2017/745 (MDR).

  This document provides guidance to manufacturers, notified bodies, expert panels, health institutions, and regulators on the clinical evidence requirements for orphan IVDs and for IVDs that have an orphan indication within the meaning of this guidance. The...

The European Medicines Agency (EMA) has released Revision 24 of its nitrosamine Q&A, introducing several important updates: https://lnkd.in/gAvk967S

Team-NB members adopted, at the unanimity of the presents, an updated version od the Code of conduct including a new paragraph requiring notified bodies to have a QMS process to investigate suspected certificate falsification or misuse, preserve evidence, take...

As the European Union prepares to revise its Good Distribution Practice (GDP) Guidelines, GIRP, the European Healthcare Distribution Association, launches today its front-running position paper setting out key priorities of the sector.GIRP suggests that the new GDP...

This document provides guidance to manufacturers, notified bodies, expert panels, health institutions, and regulators on the clinical evidence requirements for orphan IVDs and for IVDs that have an orphan indication within the meaning of this guidance. The guidance is...

Industry Stakeholder Platform Operation of EU Pharmacovigilance 20 October 2026 Luis Pinheiro (Data Analytics and Methods Task Force) Julie Durand (Pharmacovigilance Office)

A nova ICH Q1 irá impactar em todas as etapas do ciclo de vida do produto; com alterações  significativas no desenho das  estratégias de estabilidade , condições de armazenamento, interpretação de dados, avaliação estatística dos resuldados, inconsistências / gaps,  e...

1. Current situation in EUDAMED: The summary of safety and clinical performance and the summary of safety and performance (SSCP and SSP respectively), are to be uploaded by the notified body during the process of registering certificates information according to...

In order to assure a harmonised conduct of inspections, with respect to the  2022 revision of GMP Annex 1, this document provides answers to key questions related to the changes in Annex 1 raised during the revision process and after implementation of the new version....

This document, first published on 7 April 2020, has been updated to refer to currently applicable Regulation (EU) No 536/2014 on clinical trials on medicinal products for human use and to the revised ICH E6 (R3) Guideline for Good Clinical Practice. References to...

Examining how healthcare contexts shape the risks,responsibilities, and evaluation of AI systems and related standards Prepared by ISO/TC 215 Task Force 5   The International Organization for Standardization (ISO) has published a new white paper examining how the...

How to avoid delays when submitting clinical trial application assessments The UK's new clinical trial regulations came into force on 28 April 2026, introducing a more flexible and risk-proportionate approach to clinical trial assessment. Sponsors now submit a single...

As the European Health Data Space (EHDS) moves into implementation, how it is put into practice will decide how safely and coherently health data can be used across Europe. Phase4AI-EUProject is a Horizon Europe-funded project advancing the secure and...

No passado dia 26 de outubro, decorreu em Lisboa uma nova edição da formação TECH TRANSFER , bajo o lema " A 360° View Across Project Management, Quality, and Regulatory Affairs for Project Success "   Esta formação, conduzida por Alina Licova e , Silvia...

The U.S. Food and Drug Administration (FDA) issued the final guidance "Questions and Answers Regarding Mandatory Cosmetics Recalls: Guidance for Industry" as part of our ongoing activities to implement the provisions added or required by the Modernization of Cosmetics...

The U.S. Food and Drug Administration today released final guidance establishing a clear framework for how drug companies can develop, distribute, and label apps used alongside their prescription medicines. The guidance ends longstanding uncertainty by providing...

      📘  OFFICIAL DOCUMENT 

The U.S. Food and Drug Administration today released final guidance establishing a clear framework for how drug companies can develop, distribute, and label apps used alongside their prescription medicines.   The guidance ends longstanding uncertainty by...

No passado dia  21 de outubro, decorreu em Lisboa a formação  Plano de Controlo de Qualidade e Conformidade Legal de SUPLEMENTOS ALIMENTARES, focada no Controlo de Qualidade, e na Conformidade Legal antes da colocação no Mercado.   A formação , conduzida por...

Guidance on the registration requirements for medical devices placed on the market and put into service Published 20 July 2026

Artificial intelligence (AI) has the ability to transform healthcare for the benefit of both healthcare providers and patients. Implementing a framework that facilitates the (re-)use of data is pivotal to its advancement. However, the development and deployment of AI...

Patients across Great Britain will have continued access to medical devices and in vitro diagnostic devices (IVDs) already approved for the EU market.   Patients across Great Britain will continue to have access to the medical devices and in vitro diagnostic...

The content of section 5.1 (“Pharmacodynamic properties”) of the Summary of Product Characteristics (SmPC) is proposed by the applicant or marketing authorisation holder and it is assessed by the rapporteur/s. The final content is discussed by the Committee for Human...

The objective of this workshop was therefore to gather structured, experience-based input from industry on the control, governance, and mitigation measures applied throughout the AI system lifecycle, with particular emphasis on the application of ICH Q9 quality risk...

Guideline published on: 24/09/2026 Good Manufacturing Practice (GMP) provides the foundation for ensuring that medicinal products are consistently manufactured and controlled according to appropriate quality standards.

On 25 January 2025, the date of coming into effect, ICH Guideline M13A on bioequivalence for immediate-release solid oral dosage forms supersedes applicable parts of this EMA guideline related to bioequivalence study considerations and data analysis for a...

the FDA issued final guidance to help dietary supplement manufacturers and distributors prepare new dietary ingredient notifications (NDINs) with appropriate identity and safety information. The guidance addresses frequently asked questions about NDIN submissions,...

This document presents the Adverse Drug Reaction (ADR) chapter of the Data Quality Framework  (DQF) for medicines regulation published by the European Medicines Agency   (hereafter  referred to as European Medicines Regulatory Network (EMRN) DQF). It is an extension...

The European Commission has published Version 7.4 of the Questions & Answers on Clinical Trials Regulation (EU) No 536/2014 (CTR), dated October 2026. This document sets out frequently-asked 'questions and answers' regarding the implementation of the rules on...

The HMA initiative “clinical trial applications advice pilot”, coordinated by the CTCG, will become a permanent initiative from January 2027. This pilot, developed in close collaboration with the European Medicines Agency (EMA), provides clinical trial sponsors with...

The Transparency Roadmap reflects the agency’s intention to maximize disclosure, guided by what is appropriate and good for public health. It was shaped by soliciting ideas and expertise from innovators across the agency, and it may continue to evolve as we seek the...

On 14 October 2026, the European Commission published the reference to EN 18286:2026 in the Official Journal of the EU 👉 https://lnkd.in/dkte6BZB   With Commission Implementing Decision (EU) 2026/2274, the reference to EN 18286:2026 "Artificial...

The Council has adopted the ‘pharma package’, a new set of rules that will increase patients’ access to medicine and make the EU’s pharmaceutical sector fairer and more competitive. The package represents a far-reaching reform of the EU’s pharmaceutical legislation...

The Commission has adopted its first decision to select two medical devices for joint clinical assessment under the EU Health Technology Assessment (HTA) Regulation. The two devices are both addressing cardiovascular disease. One of the selected devices is the SAPIEN...

The FDA has published an updated version of the ICH E2B(R3) Electronic Transmission of Individual Case Safety Reports (ICSRs) Implementation Guide. FDA has adopted the E2B(R3) data standards, and the documents listed below reflect FDA’s recommendations for...

The updated PIC/S PI 006-4 guideline replaces the 2007 version (PI 006-3) to harmonize inspection practices with PIC/S GMP Annex 15 and modern lifecycle concepts. It details regulatory expectations across the entire qualification and validation spectrum

This document is the sixteenth annual report of the Pharmacovigilance Inspectors Working Group (PhV IWG). The PhV IWG was established by the European Medicines Agency (hereinafter “the Agency”) within the scope of Article 57(1)(i) of Regulation (EC) No 726/2004....

These questions and answers have been produced for guidance only and should be read in conjunction with the rules governing medicinal products in the European Union, volume 2, notice to applicants. MAHs must in all cases comply with the requirements of Community...

Technical and regulatory support for preparing clinical trial applications will continue from January 2027   Objectives: • Engage stakeholders, patients • Strengthen EU competitiveness • Enable innovation • Facilitate inclusive clinical trials • Foster excellent...

Marketing authorisation holders wishing to receive an outcome in 2026 should submit type IA annual updates, individual type IA and type IAIN variations, and super-groupings no later than 20 November 2026. This deadline allows EMA to acknowledge the validity of...

On october 2 , the EMA published its multi-stakeholder workshop report on Annex 22 ("Artificial Intelligence" )   EMA aims to achieve the following objectives via this workshop: Collect expert insights on responsible AI requirements, risk identification and...

FDA has adopted the E2B(R3) data standards, and the documents listed below reflect FDA’s recommendations for implementing the E2B(R3) data standards. The main document is the E2B(R3) Electronic Transmission of Individual Case Safety Reports (ICSRs) Implementation...

  The Council has adopted the ‘pharma package’, a new set of rules that will increase patients’ access to medicine and make the EU’s pharmaceutical sector fairer and more competitive. The package represents a far-reaching reform of the EU’s pharmaceutical...

The present document provides CT sponsors with the operational guidance they need to submit ASRs through the New Safety Module on ASR, including responding to the relevant Requests for Information (RFI). It is foreseen that this module will be integrated in the...

É com grande satisfação que anunciamos que a Formiventos é, pelo quinto ano consecutivo,  empresa certificada TOP 5% MELHORES PME PORTUGAL, edição de 2026, certificação atribuída pela SCORING, em termos de desempenho e solidez financeira.  Este feito é motivo de...

This guidance describes the technical standards associated with preparation of the electronic  submission template for PMAs/PMA supplements that enable submission of the Designated  Application Types solely in electronic format. This does not include PMA Modules and...

The Medical Device Single Audit Program (MDSAP) has released an updated version of its Technical Review and Recognition Decision Procedure (MDSAP AS P0017.005), effective 1 September 2026.   This procedure applies to a technical review process that is to occur...

  The purpose of this document is to share high-level principles on the use of PCCPs as a way of authorizing certain planned medical device software modifications for which regulatory authorization is otherwise required. Additionally, it aims to identify the...

This report covers the period from 2017 to 2024, during which the programme expanded from 10 to 13 authorities, including Health Canada, PMDA Japan, and ANVISA Brazil. The COVID-19 pandemic significantly disrupted on-site inspections activities but also accelerated...

The GMP & GDP Question and Answer Guide has now been published by the ECA in a fully revised Version 03. The guide summarises the Q&As developed by the FDA, EMA/EU, ICH and MHRA, and supplements these with the ECA’s own GMP and GDP Q&As.