NOTICIAS

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...

Considerations for Complying With 21 CFR 211.110 Guidance for Industry

Considerations for Complying With 21 CFR 211.110 Guidance for Industry

This guidance, when finalized, will describe considerations for complying with the requirements  in 21 CFR 211.110 to ensure batch uniformity and drug product integrity. In addition, this guidance discusses related quality considerations for drug products that are...

New EU rules for health technology assessments become effective

New EU rules for health technology assessments become effective

EMA is ready to support the implementation of the new regulation on health technology assessment (HTAR) (Regulation (EU) 2021/2282) when it becomes applicable on 12 January 2025. The regulation is an important step forward in accelerating and widening access to new...

A common EU approach to data transparency in medicine regulation

A common EU approach to data transparency in medicine regulation

EMA and HMA (Heads of Medicines Agencies) have published a comprehensive overhaul of their guidance on the identification of commercially confidential information (CCI) and personal data in marketing authorisation applications for human medicines. The update reaffirms...

Global Unique Device Identification  Database (GUDID)

Global Unique Device Identification Database (GUDID)

The Food and Drug Administration (FDA) is responsible for protecting the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products, medical devices, the nation’s food supply, cosmetics,...

Embalagens Multilingue

Embalagens Multilingue

Publicado no site  INFARMED   O Infarmed promove e incentiva o uso de embalagens multilingue atendendo à necessidade de garantir o acesso pelos doentes e profissionais de saúde aos medicamentos. Assim o Infarmed convida à consulta das recomendações constantes das...

Implementation of the Regulation on health technology assessment

Implementation of the Regulation on health technology assessment

The Regulation (EU) 2021/2282 on health technology assessment (HTAR) entered into force on 11 January 2022 and will apply from 12 January 2025. In the preparatory phase for the implementation of the HTAR (January 2022 – January 2025), this webpage aims at informing...

Smooth transition to the mandatory use of EUDAMED

Smooth transition to the mandatory use of EUDAMED

In the light of the anticipated go-live of most European database on medical devices (EUDAMED) modules in 2025, MedTech Europe summarises in a position paper the industry viewpoints on the smooth transition to the mandatory use of the European database for medical...