NOTICIAS

Acceptable Media for Electronic Product User Manuals

Acceptable Media for Electronic Product User Manuals

FDA is issuing this guidance to allow manufacturers to provide user manuals accompanying electronic products in either paper or electronic form. This is done to recognize that electronic media are now being widely used to provide instruction, while at the same time...

MDSAP AUDIT APPROACH UPDATED.  Revision Date: 2024-08-06.

MDSAP AUDIT APPROACH UPDATED. Revision Date: 2024-08-06.

The design of the Medical Device Single Audit Program (MDSAP) audit process is to ensure a single audit will provide efficient yet thorough coverage of regulatory requirements. These requirements include; Medical devices – Quality management systems – Requirements for...

Clinical Trials Information System (CTIS) – Sponsor Handbook

Clinical Trials Information System (CTIS) – Sponsor Handbook

The aim of the EMA CTIS Sponsor Handbook (‘Handbook’) is to provide clinical trial (CT) sponsors  representing pharmaceutical industry, SME (small and medium-sized enterprises), academia, research organisations and other clinical trial sponsor organisations with the...

AI Act

AI Act

The AI Act, the world’s first comprehensive artificial intelligence law, enters into force today. European citizens and businesses can now safely and confidently seize the opportunities of secure and trustworthy AI which plays by clear rules: 🔴 Unacceptable...

WHO updates laboratory biosecurity guidance

WHO updates laboratory biosecurity guidance

WHO recently issued updated guidance for national authorities and biomedical laboratories to manage biological risks. Laboratories are essential components of health systems, critical for patient diagnosis and rapid clinical care, disease surveillance, pathogen...

Harmonised rules on artificial intelligence

Harmonised rules on artificial intelligence

On 12-July "Regulation (EU) 2024/1689 of the European Parliament and of the Council of 13 June 2024 laying down harmonised rules on artificial intelligence and amending Regulations (EC) No 300/2008, (EU) No 167/2013, (EU) No 168/2013, (EU) 2018/858, (EU) 2018/1139 and...

MAKING CROSS-BORDER ACCESS TO CLINICAL TRIALS A REALITY

MAKING CROSS-BORDER ACCESS TO CLINICAL TRIALS A REALITY

The EU-X-CT Cross-Border Clinical Trials Initiative, co-led by the European Forum for Good Clinical Practice (EFGCP) and EFPIA, is dedicated to enhancing access to cross-border clinical trials in Europe. This initiative focuses on identifying barriers to participation...

2024 DIGITAL DECADE EHEALTH INDICATOR STUDY FINAL REPORT

2024 DIGITAL DECADE EHEALTH INDICATOR STUDY FINAL REPORT

This study presents the results of the monitoring framework for the eHealth 2030 target. The primary purpose of this study is to provide the Member States and the European Commission with an annual report on the advancement towards achieving the eHealth target. The...

IMDRF FINAL DOCUMENT: IMDRF Standard Operating Procedures. 24 June 2024

IMDRF FINAL DOCUMENT: IMDRF Standard Operating Procedures. 24 June 2024

The International Medical Device Regulators Forum (IMDRF) is a voluntary group of medical device regulators from around the world who have come together to build on the strong foundational work of the Global Harmonization Task Force on Medical Devices (GHTF) and aims...

Laboratory Developed Tests: Small Entity Compliance Guide

Laboratory Developed Tests: Small Entity Compliance Guide

FDA has prepared this Small Entity Compliance Guide to assist small entities in complying with the requirements established in FDA regulations as they apply to in vitro diagnostic products (IVDs), including LDTs. The LDT Final Rule amends FDA regulations to make...

EFPIA The Pharmaceutical Industry in Figures Key Data 2024

EFPIA The Pharmaceutical Industry in Figures Key Data 2024

With €50 billion invested in R&D in Europe in 2023, the pharmaceutical industry is the sector that invests the greatest percentage of its revenue in R&D. However, last year, China surpassed Europe as a region for launching new active substances globally. After...

Templates a utilizar no âmbito da disponibilidade dos medicamentos

Templates a utilizar no âmbito da disponibilidade dos medicamentos

INFARMED 24 jun 2024 Circular Informativa n.º 040/CD/100.20.200 de 24/06/2024 A rede HMA1 e a EMA2 publicou os seguintes templates a ser adotados pelos titulares de autorização de introdução no mercado (AIM) no âmbito da disponibilidade dos medicamentos: Medicine...

MDCG 2024-10 Clinical evaluation of orphan medical devices

MDCG 2024-10 Clinical evaluation of orphan medical devices

This document provides guidance to manufacturers and notified bodies on the clinical evaluation pursuant to the MDR of medical devices and accessories for medical devices that qualify as ‘orphan devices’ (OD) and medical devices and accessories for medical devices...

Norma orientadora sobre as diversas categorias de alterações

Norma orientadora sobre as diversas categorias de alterações

O enquadramento regulamentar referente às alterações às autorizações de introdução no mercado (AIM) de medicamentos para uso humano encontra-se em revisão por parte da Comissão Europeia (CE) em conjunto com os Estados-membros. O objetivo desta revisão é estabelecer um...

Novas regras de transparência do CTIS entrarão em vigor a 18 de junho

Novas regras de transparência do CTIS entrarão em vigor a 18 de junho

www.infarmed.pt   No dia 18 de junho entrarão em vigor as novas regras de transparência da base de dados europeia de ensaios clínicos CTIS (Clinical Trials Information System), juntamente com a atualização do portal público do CTIS. Até agora, foi publicada toda...

Relatório | Sistema Nacional de Farmacovigilância | 2023

Relatório | Sistema Nacional de Farmacovigilância | 2023

O INFARMED, I.P. divulga o relatório de atividades do Sistema Nacional de Farmacovigilância correspondente ao ano de 2023. Até ao final de 2023, o Portal de notificação de RAM (Portal RAM) registou cerca de 155.497 notificações de suspeitas de reações adversas a...

EU Health data centre and a common data strategy for public health

EU Health data centre and a common data strategy for public health

Regarding health data, its availability and comparability, the Covid-19 pandemic revealed that the EU has no clear health data architecture. The lack of harmonisation in these practices and the absence of an EU-level centre for data analysis and use to support a...

COMMISSION IMPLEMENTING DECISION amending Implementing Decision C(2021) 2406 on a standardisation request to the European Committee for Standardization and the European Committee for Electrotechnical Standardization as regards medical devices

COMMISSION IMPLEMENTING DECISION amending Implementing Decision C(2021) 2406 on a standardisation request to the European Committee for Standardization and the European Committee for Electrotechnical Standardization as regards medical devices

The second amendment to the MDR/IVDR standardisation request M/575 has been adopted on 27 May 2024 as "COMMISSION IMPLEMENTING DECISION amending Implementing Decision C(2021) 2406 on a standardisation request to the European Committee for Standardization and the...

Medical devices: Council adopts new measures to help prevent shortages

Medical devices: Council adopts new measures to help prevent shortages

The Council has adopted new rules updating the law on medical devices in order to help prevent shortages and ease the transition to greater transparency and access to information. The regulation adopted today amends the legislation on medical devices, including...

COST AND VALUE OF REGULATORY DATA PROTECTION

COST AND VALUE OF REGULATORY DATA PROTECTION

The European Union (EU) General Pharmaceutical Legislation (GPL) lays down provisions related to medicinal products authorisation and post-authorisation requirements, preauthorisation support schemes, regulatory incentives in terms of data and market protection,...