NOTICIAS

Playbook for Medical Device Regulatory Reliance Programs

Playbook for Medical Device Regulatory Reliance Programs

This document provides high-level strategies for developing regulatory reliance  programs for medical devices, along with specific considerations and steps related to  actual program implementation. It is intended to be equally applicable to all medical devices....

ICH M11 Technical Specification . Updated Step 2b

ICH M11 Technical Specification . Updated Step 2b

The purpose of this new harmonised guideline is to introduce the clinical protocol template and the technical specification to ensure that protocols are prepared in a consistent fashion and provided in a harmonised data exchange format acceptable to the regulatory...

FDA Novel Drug Therapy Approvals for 2024

FDA Novel Drug Therapy Approvals for 2024

"Novel" drugs are new drugs never before approved or marketed in the U.S. See Drugs@FDA for information about all of CDER’s approved drugs and biological products.   In 2024, CDER approved 50 new drugs never before approved or marketed in the U.S., known as...

Digitalisation of Technical Documentation

Digitalisation of Technical Documentation

The transition in the European Union (EU) regulatory landscape for medical devices (MDs) and in vitro diagnostic medical devices (IVDs) to the Regulations ((EU) 2017/745 and (EU) 2017/746) brings with it a large step-up in the volume of documented evidence required to...

Decreto-Lei n.º 23/2025 relativo aos produtos cosméticos

Decreto-Lei n.º 23/2025 relativo aos produtos cosméticos

Foi publicado em Diário da República o Decreto-Lei n.º 23/2025, de 19 de março, que assegura, na ordem jurídica portuguesa, a execução do Regulamento n.º (CE) 1223/2009, relativo aos produtos cosméticos O diploma ora publicado ao assegurar a execução da legislação...

Submission of vigilance reports to Notified Bodies under EU MDR & IVDR

Submission of vigilance reports to Notified Bodies under EU MDR & IVDR

Vigilance reports are a crucial part of a systematic and integrated post-market surveillance (PMS) system established through the Medical Devices Regulation (EU) 2017/745 (MDR) and the In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746 (IVDR) to ensure the...

ENISA Cybersecurity Maturity & Criticality Assessment of NIS2 sectors

ENISA Cybersecurity Maturity & Criticality Assessment of NIS2 sectors

This report offers both a cross-sectoral overview and a detailed sector-by-sector analysis of the criticality and maturity of assessed sectors. Building on the insights gathered, it highlights the strengths of and challenges faced by each sector assessed, identifies...

Questions and answers on the Critical Medicines Act

Questions and answers on the Critical Medicines Act

What does the Critical Medicines Act aim to achieve and how? The Critical Medicines Act aims to address the issues above, by: strengthening Europe's manufacturing capacity; diversifying supply chains; reducing the EU's dependencies; incentivising resilience;...

Gestão da Disponibilidade do Medicamento :Novos Regulamentos

Gestão da Disponibilidade do Medicamento :Novos Regulamentos

Foram publicadas em Diário da República as novas deliberações do Infarmed relativas à gestão da disponibilidade e exportação de medicamentos. As novas regras aplicam-se aos titulares de Autorização de Introdução no Mercado, distribuidores grossistas, farmácias...

A Global Health Strategy for 2025–2028

A Global Health Strategy for 2025–2028

What’s new in this global health strategy, the GPW 14? Building on the evaluation of WHO’s Thirteenth General Programme of Work, 2019-2025 (GPW 13), the 2023 global monitoring report on UHC (2023)3 and lessons learned from the COVID-19 pandemic, GPW 14: (i) sets a...

European Health Data Space

European Health Data Space

      REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on the European Health Data Space and amending Directive 2011/24/EU and Regulation (EU) 2024/2847   The aim of this Regulation is to establish the European Health Data Space (EHDS) in...

Biotech regulation: Making Europe fit for the future

Biotech regulation: Making Europe fit for the future

Germany, February 2025 - BioTech Brief: Making Europe fit for the future. This BioTech Letter focuses on biotechnology regulation and was published by the German Association of Biotechnology Industries within the German Chemical Industry Association - VCI. "In early...

Keeping health high on the agenda: the European Health Report 2024

Keeping health high on the agenda: the European Health Report 2024

WHO through one of its flagship publications, the European Health Report, supports countries by providing a call to action and guiding framework. The 2024 edition of the European Health Report shows that people’s health in the WHO European Region continues to be...

FDA  Compliance Program Guide for Inspections of Outsourcing Facilities

FDA Compliance Program Guide for Inspections of Outsourcing Facilities

The goal of this compliance program's activities is to ensure that establishments consistently produce drug products of acceptable quality and minimize consumers' exposure to adulterated drug products. Under this compliance program, inspections, investigations, sample...

Novo regulamento da gestão da disponibilidade do medicamento

Novo regulamento da gestão da disponibilidade do medicamento

Foram publicadas em Diário da República as novas deliberações do Infarmed relativas à gestão da disponibilidade e exportação de medicamentos. As novas regras aplicam-se aos titulares de Autorização de Introdução no Mercado, distribuidores grossistas, farmácias...

Data Integrity  Frequently Asked Questions (FAQ)

Data Integrity Frequently Asked Questions (FAQ)

This document contains a collection of frequently asked questions that have been submitted by the industry to the DI taskforce. The intention of this documents is that this is a living document that will be updated as new questions are opposed to the group

Relatório Anual da Gestão da Disponibilidade de Medicamentos de 2024

Relatório Anual da Gestão da Disponibilidade de Medicamentos de 2024

O Relatório Anual da Gestão da Disponibilidade de Medicamentos de 2024, divulgado pelo INFARMED. I.P., sublinha o papel fundamental da entidade na monitorização e gestão do abastecimento de medicamentos em Portugal. Segundo o relatório, 97% das apresentações de...

Bioanalytical Method Validation for Biomarkers

Bioanalytical Method Validation for Biomarkers

This guidance helps sponsors of investigational new drug applications (INDs) and applicants of new drug applications (NDAs), biologics license applications (BLAs), and NDA and BLA supplements as well as abbreviated new drug applications (ANDAs), as applicable, to...

Questions & Answers for applicants, marketing authorisation holders of medicinal products and notified bodies with respect to the implementation of the Regulations on medical devices and in vitro diagnostic medical devices (Regulations (EU) 2017/745 and (EU) 2017/746)

Questions & Answers for applicants, marketing authorisation holders of medicinal products and notified bodies with respect to the implementation of the Regulations on medical devices and in vitro diagnostic medical devices (Regulations (EU) 2017/745 and (EU) 2017/746)

This Question and Answer (Q&A) document provides practical considerations concerning the implementation of the medical devices and the in vitro diagnostic medical devices regulations in the context of combinations of medicinal products with medical devices. This...

EU Cosmetics Deadlines – New Rules Effective 01 February 2025 

EU Cosmetics Deadlines – New Rules Effective 01 February 2025 

EU Cosmetics Deadlines – New Rules Effective 01 February 2025 In early 2024, the EU announced new restrictions and bans on certain substances in cosmetics, including updates to Annex II and Annex III. Starting February 1, 2025, certain deadlines will take effect...

Biomanufacturing: Europe’s Industrial Future

Biomanufacturing: Europe’s Industrial Future

Published today, the "Biomanufacturing: Europe's Industrial Future" paper explores the current status and future options and opportunities for biomanufacturing in Europe, underpinned by data and examples. Industry across sectors face challenges in reducing the...