NOTICIAS

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...

  Important development for the MDR and IVDR regulatory framework The Commission Implementing Regulation (EU) 2026/977 of 4 May 2026 - on Annex VII - has been published in the Official Journal of the European Union COMMISSION IMPLEMENTING REGULATION (EU)...

No passado 29 de abril de 2026 decorreu em Lisboa o Master Course Autorização, publicidade e comercialização de SUPLEMENTOS ALIMENTARES,  bajo o lema "Uma visão exaustiva , atual e prática dos conhecimentos imprescindíveis para fabricar, introduzir e manter-se no...

The EDQM hospital medicine traceability guidelines aim at reducing medication errors and enhancing patient safety. It has been drafted by a Working Group and two Committees of Experts under the European Committee on Pharmaceuticals and Pharmaceutical Care (CD-P-PH),...

MDCG 2021-12 Rev.2: Updated FAQ on EMDN The revised MDCG 2021-12 Rev.2 FAQ on the European Medical Device Nomenclature (EMDN) is now available This document has been endorsed by the Medical Device Coordination Group (MDCG) established by Article 103 of Regulation (EU)...

Certification of suitability to the Monographs of the European Pharmacopoeia GUIDELINE ON REQUIREMENTS FOR REVISION/RENEWAL OF CERTIFICATES OF SUITABILITY TO THE EUROPEAN PHARMACOPOEIA MONOGRAPHS   The holder of a certificate of suitability (CEP) shall inform the...

  Questions and Answers (Q&As) on the European Medicines Agency policy on the publication of clinical data for medicinal products for human use (Policy 0070) work-share initiative with Health Canada (HC) The work-share process is a voluntary collaborative...

No passado dia 21 de abril , teve lugar a sessão formativa PLANOS DE CONTINGÊNCIA /BUSINESS CONTINUITY em Farmacovigilância, conduzida por  ​Ana Maria  Tome, Senior Consultant  GVP, na ADAMAS Consulting Nesta formação foram analisadas  as chaves, os conteúdos  e as...

“Gostei muito da formação, achei muito enriquecedora e interessante . Gostei particularmente dos momentos de discussão e partilha de conhecimentos .” FRESENIUS-KABI Decorreu no passado dia 21 de abril, em Lisboa, a edição 2026 da formação  CTD MODULO 3, conduzida...

  The European Commission has updated the manual on borderline and classification Regulation (EU) 2017/745 on medical devices (MDR) and Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR)(Version 5, April 2026) in April 2026 to include...

Foi publicada em Diário da República a Deliberação n.º 324/2026, de 18 de março, que aprova o regulamento relativo à comunicação de efeitos indesejáveis associados à utilização de produtos cosméticos. A deliberação, da responsabilidade do INFARMED vem reforçar os...

Decorreu ontem, dia 21 de abril, o WORKSHOP PC-BASED : EUDAMED 2026   , bajo o lema " Formação técnica e prática detalhada, centrada na utilização real da EUDAMED, para garantir a conformidade operacional total da sua empresa e dos seus produtos antes da sua...

This report draws on the 2024–2025 survey on AI for health in the WHO European Region, offering a focused lens on the EU. All 53 Member States of the WHO European Region received the survey, and 50 chose to participate (a 94% response rate), including all 27 EU Member...

This validation checklist is used by the Agency to validate initial marketing authorisation applications for pharmaceuticals and applicants should use it as a means to review in advance of their submission that standard requirements are fulfilled.

The Medical Device Coordination Group (MDCG) has published MDCG 2021-24 Rev.1 (April 2026), updating its guidance on the classification of medical devices under MDR (EU) 2017/745. This revision provides further clarification and practical examples to support...

Over the last year, something shifted. The EMA–FDA joint Good AI Practice Principles (Jan 2026), the CIOMS Working Group XIV final report (Dec 2025), and the EU AI Act high-risk rules taking effect this August have moved AI in PV from "interesting pilot" to "regulated...

This presentation relates to Annex II.1 of ICH Q9(R1) To ensure the adequate management of risks and continuous improvement, it is essential for the principles and practices of QRM to be fully integrated within the PQS as outlined by ICH Q9 (R1). • ICH Q9 (R1) is not...

This report presents 73 examples of market authorizations from fiscal years (FY) 2020-2025 building on the foundational work presented in the 2021 publication “Examples of Real-World Evidence (RWE) Used in Medical Device Regulatory Decisions,” which documented 90...

Update: April 10, 2026 The FDA has updated its Electronic Medical Device Reporting (eMDR) framework, confirming the transition to the ESG NextGen Unified Submission Portal As of April 14, 2025, the ESG NextGen portal replaces the legacy WebTrader interface, providing...

European Commission and HMA published the materials from the ACT EU webinar (8 April) presenting the new draft guidance on the conduct of clinical trials during public health emergencies (PHEs) — Now open for public consultation until 30 April 2026.

The European Medicines Agency (EMA) has released a draft roadmap for the implementation of electronic Product Information (ePI). This marks a major shift from traditional Word/PDF documents to a fully digitized, structured format designed to improve accessibility and...

This document is based on questions frequently raised to EMA by sponsors during CTIS events such as Walk-in Clinics, Bitesize Talks, and through the EMA CTIS Service Desk. It serves as complementary document to the Sponsor Handbook, which is the main operational...

The EMA Clinical Trials Information System (CTIS) Sponsor Handbook provides clinical trial (CT) sponsors representing pharmaceutical industry, SME (small and medium-sized enterprises), academia, research organisations and other clinical trial sponsor organisations...

Q&A on practical aspects related to the implementation of the Article 10a obligation in case of interruption or discontinuation of supply of certain devices as introduced by Regulation (EU) 2024/1860 amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards...

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 where AI-enabled medical devices may...

The latest publication of harmonised standards under the Medical Devices Regulation (MDR) – April 2026 is now available. These updates are essential for manufacturers and stakeholders to demonstrate compliance with the MDR, providing presumption of conformity with the...

In March 2026, the now final "Guideline on the chemistry of active substances" was published on the EMA website. As reported in the news "EMA/CHMP: New Guideline Draft on Active Substances published for Comment", the draft guideline was open for public consultation...