NOTICIAS

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...

“Muito interessante em termos de conteúdos . Mas também na partilha de experiências . Muito enriquecedor “. NATECH   No passado dia 30 de junho  decorreu em Lisboa, a formação GMP CANÁBIS , bajo o lema : Visão integrada sobre os processos GACP (NOVA guideline...

This novel pathway also places significant emphasis on patient engagement and communication, ensuring that people affected by rare diseases are involved throughout development and that informed consent is an ongoing, not one‑off, process. The guidance also explains...

The European Commission has published two delegated acts on Well-Established Technologies (WET) under the Medical Devices Regulation (EU) 2017/745 (MDR) in the Official Journal of the European Union. The newly published delegated regulations expand the list of WET...

26 June 2026 EMA/186412/2021 Clinical Trials Transformation Sponsor handbook :Clinical Trial Information System (CTIS) user guidance on the sponsor’s workspace Version 6.3   The most Frequently Asked Questions (FAQs) on CTIS can be found in the Sponsor FAQs,...

The European Commission has published a revised version of Annex 19 of EudraLex Volume 4. The update is focused on Section 9 of the annex which addresses reference and retention samples for parallel traded products. The revised annex includes expectations around the...

   “Formação bastante abrangente e completa. “ LAB EDOL   No passado dia 23 de junho decorreu em Lisboa a formação  GVP advanced : FARMACOVIGILÂNCIA nível avançado, desenhada para consolidar e atualizar conhecimentos e permitir o reforço dos sistemas...

This document is intended to provide guidance to applicants planning to submit new drug  applications (NDAs), biologics license applications (BLAs), or supplements to NDAs or BLAs that require the demonstration of substantial evidence of effectiveness. This guidance...

10 things to know about the proposed European Biotech Act: Positioning EU as Biotech Powerhouse

The CIOMS has released Version 10 of its Glossary of ICH Terms and Definitions, bringing together terminology from current International Council for Harmonisation (ICH) guidelines and Q&A documents. The glossary serves as a centralised reference for professionals...

The European Commission has published a new appendix to MDCG 2021-5 Rev. 1 – Guidance on standardisation for medical devices: 📄 Appendix: Transition to the “EU REP” symbol in EN ISO 15223-1 📅 Published: June 2026 This follows the publication in the...

The Medical Device Coordination Group (MDCG) has published MDCG 2026-4: Management of SS(C)P in EUDAMED after Mandatory Use, providing guidance on how Summary of Safety and Clinical Performance (SSCP) and Summary of Safety and Performance (SSP) documents will be...

📢 Regulatory Update: Commission Implementing Decision (EU) 2026/1313 On 15 June 2026, the European Commission adopted Commission  Implementing Decision (EU) 2026/1313, amending Implementing Decision (EU) 2021/1195 regarding the harmonised standard for symbols...

Publicado o Decreto-Lei n.º 118/2026, de 17 de junho, que estabelece os novos termos do SiNATS - Sistema Nacional de Avaliação de Tecnologias de Saúde (ATS)   O Decreto-Lei n.º 97/2015, de 1 de junho, instituiu, no âmbito do INFARMED - Autoridade Nacional do...

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 a step-by-step description of the registration process required to obtain access to the Public Product Management Service (PMS) Application Programming Interface (API) environment. The Public PMS API supports access to data managed within the...

A fourth report based on studies EMA conducted using real-world data between February 2025 and February 2026 is available. The report summarises the progress in integrating real-world evidence in regulatory decision-making. It contains a list of research topics and a...

INTERNATIONAL COUNCIL FOR HARMONISATION OF TECHNICAL REQUIREMENTS FOR PHARMACEUTICALS FOR HUMAN USE  HARMONISED GUIDELINE GUIDELINE FOR GOOD CLINICAL PRACTICE E6(R3) Annex 2. Final version Adopted on 03 June 2026

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...

Artificial Intelligence (AI) is fast evolving and is rapidly transforming the development and supervision of medicines. The EU AI Act entered into force in 2024 and represents a significant step towards ensuring that AI is developed and used in a trustworthy,...