NOTICIAS

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The FDA has released a revised draft guidance (June 2026) on Master Protocols for Drug and Biological Product Development, reinforcing the growing role of innovative clinical trial designs in accelerating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

The EU has introduced a new standard template covering recruitment and informed consent procedures. The template was developed by MedEthicsEU, the European Commission's expert Ethics Committee group, using insights from more than 11,000 clinical trials authorised...

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...

In vitro diagnostics (IVDs) are essential to modern healthcare, guiding clinical decisions from routine testing to advanced diagnostics. As demand continues to grow, it is crucial that the regulatory framework reflects how these technologies work in practice.​ The...

The European Data Protection Board welcomes comments on the Guidelines 1/2026 on processing of personal data for scientific research purposes. Such comments should be sent 25th June 2026 at the latest using the provided form. Please note that, by submitting your...

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry titled “Statistical Approaches to Establishing Bioequivalence.” This guidance provides recommendations to sponsors and applicants planning to use...

Foi publicado em Diário da República a Deliberação n.º 630/2026, de 1 de junho, que aprova modelo e obrigatoriedade de reporte trimestral de atividades de cultivo e fabrico de canábis para fins medicinais.

This guidance document provides a risk-based framework to guide manufacturers and FDA staff on the human factors information that should be documented and included in medical device marketing submissions, including premarket notifications (510(k)s), De Novo requests,...

Since the Q8, Q9, and Q10 guidances were made final, experiences implementing the guidances in the ICH regions have given rise to requests for clarification. This question and answer (Q&A) document is intended to clarify key issues. The guidance reflects the...

Chapter 3: Process for the electronic submission of medicinal product information   Summary of changes 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,...

The data set for this report shows data for the months January-March 2026, as of 31 March 2026, as well as cumulative numbers since the launch of CTIS on 31 January 2022. According to Article 98 of the Clinical Trials Regulation (EU) 536/2014, the transition period...

The Council of Europe Convention on the Counterfeiting of Medical Products and Similar Crimes involving Threats to Public Health   Falsified medical products are a danger to public health and can violate the right to life enshrined in the European Convention on...

No passado 14 de maio, decorreu a edição 2026 da formação Qualificação de FORNECEDORES ,Clientes e Entidades Subcontratadas, bajo o lema :  "  Análise pormenorizada do processo de qualificação de fornecedores e clientes, para medicamentos de uso humano, uso...

GMP/GDP Update for Cannabis Modernized import and export procedures for controlled substances and medicinal cannabis  have been published in the German Federal Gazette  on 8 May 2026

Nos passados dias  15 e 16 de maio, de correu em Lisboa uma nova edição da formação sobre as BOAS PRÁTICAS de DISTRIBUIÇÃO de MEDICAMENTOS de uso humano e substâncias ativas, conduzida por Sónia Rei, Diretora Técnica na Hikma Farmacêutica (Portugal) Esta última edição...

The European Commission welcomes the political agreement reached between the European Parliament and the Council on the Critical Medicines Act. This landmark agreement will help strengthen the resilience of Europe’s pharmaceutical supply chains, reduce dependencies on...

Survey results of the 19th NB survey (MDR/IVDR) with data status 31 December 2025 (small and large dataset)

No passado 8 de maio decorreu em Lisboa a edição 2026 da formação  GDP AUDITS 2026 : AUTOINSPEÇÕES / AUDITORIA INTERNA ao Sistema de BOAS PRÁTICAS DE DISTRIBUIÇÃO.   A formação foi conduzida por Sónia Rei, Associate Director Operations da Hikma , que ofereceu uma...

MedTech Europe has recently published its new position paper: “MDR/IVDR Revision: A Regulatory System at a Crossroads – Position & Proposed Amendments”. The document highlights key challenges currently faced by the medical device industry, including regulatory...

Explore the latest improvements across the European Medicines Verification System (EMVS), strengthening performance, usability, and patient safety across the network.   If you want to learn more about this, please follow these links: https://lnkd.in/d_sJD77k...

The European Commission welcomes the political agreement reached today between the European Parliament and the Council of the EU on simpler, innovation-friendly rules for artificial intelligence (AI). The Commission proposed the Digital Omnibus on AI only five months...

    No passado 5 de maio , decorreu em Lisboa a sessão prática DIGITAL PROMO REVIEW: COMPLIANCE DIGITAL & SOCIAL MEDIA, conduzida por Sónia Ferreira, Technical Director & Local Scientific Manager na A Martins & Fernandes; bajo o lema " Uuma visão...

This best practice guidance document has been developed by members of Team NB who have reviewed the best practice guidance documents (exceeding twenty in number) submitted by individual Team NB notified body members, with the purpose to develop a unified approach on...