NOTICIAS

É com grande satisfação que anunciamos que a Formiventos é, pelo terceiro ano consecutivo, uma empresa certificada TOP 5% MELHORES PME PORTUGAL, edição de 2024, certificação atribuída pela SCORING, em termos de desempenho e solidez financeira.  A SCORING, LDA (NIF 515...

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...

This guidance provides the standards for the submission of De Novo Requests by electronic format, a timetable for establishment of these standards, and criteria for waivers of and exemptions from the requirements to meet a statutory requirement. This guidance is also...

The health and medicine sector are increasingly digitized, a trend that will accelerate with more widespread adoption of artificial intelligence, wearables and internet of things-based healthcare. Yet, this digital transformation carries notable cybersecurity threats....

ICH M13A Guideline is intended to provide recommendations on conducting bioequivalence (BE) studies during both development and post approval phases for orally administered immediate-release (IR) solid oral dosage forms designed to deliver drugs to the systemic...

Devices that according to the Medical Devices regulations are not to be registered in the UDI/Devices module but are to be referenced in a Vigilance report can be registered in EUDAMED as NRDs. For the Vigilance module, NRDs are Old Devices or Custom-made Devices....

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...

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...

Version 3.9 brings significant changes to the implementation of the Master UDI, it is essential that you keep up to date to ensure compliance with European regulations

Encontram-se disponibilizados no site do Infarmed os relatórios de monitorização do mercado de medicamentos do mercado ambulatório, hospitalar e locais de venda livre de medicamentos não sujeitos a receita médica (LVMNSRM), todos referentes ao 1.º semestre de 2024....

  ️ Important news for medical device manufacturers in the European Union!   ➡️ The Commission has renewed the designation of the UDI issuing bodies for a period of five years, from June 27, 2024 to June 27, 2029. ➡️ These...

📊 A total of 40 studies were conducted between February 2023 and February 2024. 🌐 The DARWIN EU network expanded from 10 to 20 data partners since 2023, allowing access to data from almost 130 million patients from 13 European countries - in full...

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...

The EU regulatory system for medical devices outlined in the Medical Device Regulation (MDR) and In-Vitro Diagnostics Regulation (IVDR) represents an important evolution over the previous legislation, seeking to ensure appropriate levels of protection of public health...

FDA issued a draft guidance that provides biologic product manufacturers with recommendations on the nature and type of information they should provide FDA to support postapproval manufacturing changes to biosimilar and interchangeable biosimilar products:...

O período de transição do Regulamento Europeu de Ensaios Clínicos n.º 536/2014 de 16 de abril(CTR) termina a 30 de janeiro de 2025. Desta forma, os promotores que ainda tenham ensaios clínicos autorizados, ao abrigo da Diretiva nº 2001/20/CE de 4 de abril e que esteja...

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...

This document provides guidance to industry and FDA staff on the purpose and content of a userelated risk analysis2(URRA) and how a URRA, along with other information, can be used to determine human factors (HF) data needs during product3 19 development and to support...

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...

Q&A on practical aspects related to the implementation of the extended  transitional period provided for in the IVDR, as amended by Regulation (EU) 2024/1860 of 13 June 2024 amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards a gradual roll-out of...

No âmbito do Sistema de Preços de Referência, a lista dos Grupos Homogéneos e dos preços de referência unitários a vigorar no 3.º trimestre de 2024 foi actualizada. Consulte a área Sistema de Preços de Referência, nomeadamente, a Circular Informativa Nº...

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...

This guidance, relating to the application of Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR) addresses the classification of in vitro diagnostic medical devices (IVDs) and provides clarifications on the classification rules as set out under...

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...

This document was developed for in-vitro diagnostics medical device (IVD) regulatory submissions. Submissions to request approval to conduct clinical trials are not within the scope of this document. Companion Diagnostics are in scope for this document. The document...

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...

FDA issued a new guidance to help ensure that a device’s drug-delivery function consistently performs as intended including for prefilled syringes, injectors, nasal sprays, and inhalation devices: https://lnkd.in/eGd2hREH FDA welcomes comments on this draft guidance....

Latest update on MDCG 2021-5 Rev. 1 Guidance for standardization in medical devices! Revision 1, effective from July 2024, offers comprehensive insights into various standardization aspects within the medical devices sector. This guidance aligns with EU legislation...

Artificial intelligence (AI) technologies, including machine learning, have the potential to transform health care by deriving new and important insights from the vast amount of data generated in health care every day. They use algorithms that can learn from realworld...

infarmed. 27 jun 2024 O Grupo de Coordenação dos Estados-Membros para a Avaliação das Tecnologias da Saúde adotou documentos orientadores relativos às Avaliações Clínicas Conjuntas, no âmbito do Regulamento de Avaliação de Tecnologias de Saúde (UE) 2021/2282. Todas as...

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...

Decorreu no 26 de junho a primeira edição da formação : PLANO de PREVENÇÃO de ESCASSEZ no âmbito da Gestão da Disponibilidade dos Medicamentos; uma  formação prática, que inclui análise de casos práticos , focada na partilha de boas práticas e na resolução de questões...

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...

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...

The Regulated Product Submission (RPS) proposal was endorsed as a New Work Item (NWI) by IMDRF at its inaugural meeting in Singapore (March 2012). The proposal, as endorsed, included the objective of establishing a comprehensive harmonized structure for regulated...

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...

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...

This document aims to provide guidance to the authorities responsible for notified bodies (hereafter, the Designating Authorities) and joint assessment teams (JATs) when conducting: − assessments of conformity assessments bodies (CABs) that apply for designation as a...

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...

The revised transparency rules for the Clinical Trials Information System (CTIS) will become applicable on 18 June 2024, with the launch of a new version of the CTIS public portal . The updated rules strike a balance between transparency of information and protection...

Decorreu com sucesso  mais uma eição da formação Aprovação, Formação e Revisão anual de PREÇOS de MEDICAMENTOS  , bajo o lema " Um guia completo para o desenvolvimento da estratégia de pedido de preço de medicamentos, e para a revisão anual de preços de Medicamentos...

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...

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...

Medical devices (MD) and in vitro diagnostic medical devices (IVD) are essential for a working healthcare system and have a crucial role to play in the prevention, diagnosis, monitoring, prediction, prognosis and treatment of acute and chronic illness and diseases as...

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...

The use of pharmacoepidemiological studies as a source of evidence for regulatory decision-making has increased globally, and multiple guidelines and best practice documents have been developed by health authorities and professional societies. Generation of robust...

30 May 2024 EMA publishes 2023 annual report EMA’s annual report 2023 published today details the Agency’s contributions to public and animal health in the European Union (EU). With a fresh layout and new interactive features, the report offers insights into EMA's...

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...

PUBLISHE BY EFPIA.EU   For innovative health and life science companies, European competitiveness being at the forefront of the agenda in Brussels and beyond could help reverse the loss of cutting-edge science and investment to other parts of the world.  The...

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,...

Article 120 of the Medical Device Regulation (EU) 2017/745 (MDR), as amended by Regulation (EU) 2023/6071, states that devices which are covered by valid certificates issued by a notified body under the Active Implantable Medical Devices Directive 90/385/EEC (AIMDD)...