NOTICIAS

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.

This Module contains guidance on the planning, conduct, reporting and follow-up of pharmacovigilance inspections in the EU and outlines the role of the different parties involved. General guidance is provided under III.B., while III.C. covers the overall operation of...

This guidance was designed to guide the sponsor on safety reporting from study planning and forecasting of anticipated adverse events to the detection of events during the study conduct, the analysis of causality and seriousness, as well as communication of this...

The National Commission into the Regulation of AI in Healthcare, United Kingdom has delivered a decisive roadmap that recalibrates how artificial intelligence must be governed, through its latest Recommendations for a future regulatory framework

📆 On 9 September 2026, the European Medicines Agency (EMA) published Version 1.15 of the document Electronic submission of Article 57(2) data Questions & Answers (Q&As) Version 1.15

On 1 September 2026, the European Medicines Agency issued practical guidance on the submission of electronic product information, or ePI, for centrally authorised medicinal products. The agency noted that submitting ePI is voluntary until the general pharmaceutical...

Considerations for a harmonised approach for handling changes arising from the transition to EU MDR and IVDR Looking at the impact on the Middle East and Africa (MEA) region, where CE marking serves as a major regulatory reference supporting domestic registrations,...

This document provides a report on the status of implementation of all IMDRF technical documents as self-identified by IMDRF members as of the date of publication. In addition to overseeing IMDRF documents, the IMDRF Management Committee also oversees documents...

The European Commission’s Medical Device Coordination Group  has published MDCG 2020-16 Rev.5 – Guidance on Classification Rules for in vitro Diagnostic Medical Devices under Regulation (EU) 2017/746 (IVDR), dated September 2026. This guidance, relating to the...

In June 2026, the European Commission published a revised version of EU GMP Annex 19 – Reference and Retention Samples, applicable from 24 September 2026.   Legal basis for publishing the detailed guidelines: Article 47 of Directive 2001/83/EC on theCommunity...

📆 August 2026 This guidance provides information regarding FDA’s therapeutic equivalence evaluations, including the assignment of therapeutic equivalence codes (or TE codes). As defined in 21 CFR 314.3(b), therapeutic equivalents are approved drug products...

This paper is not intended to propose or implement policy changes regarding how CDRH intends to regulate generative AI-enabled devices. This paper is not intended to communicate CDRH’s proposed (or final) regulatory expectations, including its expectations for...

The European Medicines Agency has issued an updated guideline to assist marketing authorisation holders (MAHs) to create and maintain drug shortage prevention plans (SPPs) for their products. The main objective of the SPPs is to ensure the MAH has appropriate systems...

📆 Effective 1 October 2026:   This document updates and renames the previous document, PI 006-3 dated 25 September 2007 titled ‘Recommendations on validation master plan, installation and operational qualification, non-sterile process validation, cleaning...

The WHO has recently published a draft guideline, including two annexes, on Good Clinical Practice (GCP) for clinical trials involving medicinal products. Comments on these documents may be submitted until 6 September 2026 Access the documens here: Guidelines for Good...

After the release of version 2 of this guideline, important discussions took place which led to significant changes in the information provided. As a result, version 3 of this document has been completely revised, and previous versions should no longer be taken into...

On 27 July 2026, the AI Omnibus enters into force across the EU, bringing extended timelines to administrative simplification. The AI Omnibus, proposed as part of the digital omnibus package on 19 November 2025, delivers a targeted simplification of the AI rulebook...

The European Commission and EU agencies have officially released Version 7.3 of the EU Clinical Trials Regulation (CTR) Q&A guidance. You can download the full, updated guidance directly from here

This report considers how best to address this growing gap in ethical oversight. The document examines how standards for research ethics may need to evolve to address the risks and benefits of AI-related health research and to integrate emerging ethical principles...

This document is based on the EU Commission Guideline on the principles of Good Distribution Practice of active substances for medicinal products for human and veterinary use and therefore follows the same structure. This APIC document provides guidance on practical...

TRANSFER AGREEMENT FOR SURVEILLANCE OF LEGACY DEVICES specifying the terms of the transfer of the appropriate surveillance activities according to Article 120 (3e) of Regulation (EU) 2017/7451 in respect of legacy devices covered by a certificate issued in accordance...

The purpose of this consensus document is to describe in detail the pre-application, application processes through which manufacturers may apply to Notified Bodies (NBs) for the certification of medical devices under the regulation (EU) 2017/745 (MDR). The document...

This document provides guidance on risks specific to artificial intelligence (AI) and machine learning (ML) and how to apply the risk management process of ISO 14971 to ML-enabled medical devices (MLMD). This document is intended to be used in conjunction with...

The European Commission published guidelines to assist providers and deployers of artificial intelligence (AI) systems in meeting the AI Act's transparency obligations, which start to apply on 2 August 2026. Transparency obligations will help people recognise when...

This MDCG Position Paper aims at explaining the point to clarify the situation and avoid confusion, misunderstandings or potential misuse arising from differing interpretations between manufacturers and distributors, as well as the EU UDI issuing entities. This should...

This guidance document addresses a number of questions which stakeholders, in particular the marketing authorisation holders (MAHs)/applicants, may have on an Article 31 non-pharmacovigilance referral procedure. It provides an overview of the European Medicines...

Q&A on practical aspects related to the implementation of Regulation (EU) 2023/607 amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards the transitional provisions for certain medical devices and in vitro diagnostic medical devices REV. 2. JULY 2024

📢Updated guidance for the International Recognition Procedure (IRP) is now available.   As part of the MHRA commitment to continuously improving our regulatory processes, we've updated the IRP guidance to reflect several changes that will come into effect...

This document aims to provide guidance on different aspects related to standards in the medical devices sector in support of the requirements laid down in the applicable EU legislation, taking into account its specificities

The EMA Qualification of Novel Methodologies (QoNM) provides a voluntary, scientific pathway to support development, evaluation and regulatory endorsement of innovative methodologies in specific contexts of use. In this guidance, the term ‘methodologies’ refers to...

The FDA has released a revised draft guidance (June 2026) on Master Protocols for Drug and Biological Product Development, reinforcing the growing role of innovative clinical trial designs in accelerating drug development.

Survey results of the 20th NB survey (MDR/IVDR) with data status 28 February 2026 (small and medium dataset)

Closing date: Friday, 10 July 2026 This document is intended for manufacturers that are developing AI-enabled medical devices to  identify considerations as they make critical technical and governance choices. It is intended to  provide considerations specific to...