NOTICIAS

“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...

  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...