NOTICIAS

New Health Technology Assessment (HTA) Regulation

New Health Technology Assessment (HTA) Regulation

European collaboration between regulators and health technology assessment bodies Joint work plan (2021-2023) between EMA and European HTA bodies facilitated through EUnetHTA21 Close collaboration between EMA and the EUnetHTA 21 consortium aims to support preparing...

Big Data strategy for veterinary medicines in the EU

Big Data strategy for veterinary medicines in the EU

The European Medicines Agency (EMA) and the Head of Medicines Agencies (HMA) have adopted a  Veterinary Big Data strategy to 2027 outlining their vision for fostering data-driven, digital innovations in the veterinary medicines’ domain in the European Union (EU)....

EMA publishes annual report 2021

EMA publishes annual report 2021

EMA’s annual report 2021 published today provides an overview of the Agency’s activities to protect and promote public and animal health in the European Union (EU) and highlights EMA’s most significant achievements. These include the Agency’s activities to tackle the...

EMA releases final guideline on antibacterial drug development

EMA releases final guideline on antibacterial drug development

The Guideline is relevant to antibacterial agents with a direct action on bacteria resulting in inhibition of replication leading to bacterial cell death including: • Antibacterial agents developed as single agents; • Antibacterial agents developed for use in...

EMA Publishes Final Guidelines on Quality and Specifications for HMPs

EMA Publishes Final Guidelines on Quality and Specifications for HMPs

This guideline concerns the application of Module 3 of Annex I to Directive 2001/83/EC for human herbal medicinal products (HMPs) and Part 2 of the dossier as established by Commission Delegated Regulation (EU) 2021/805 amending Annex II of Regulation (EU) 2019/6 for...

MDCG 2022-9 Summary of safety and performance  Template May 2022

MDCG 2022-9 Summary of safety and performance Template May 2022

Regulation (EU) 2017/746 on in vitro diagnostic medical devices (the IVDR) requires that the manufacturer shall draw up a summary of safety and performance (SSP) for class C and D devices, other than devices for performance studies. The SSP shall be validated by a...

ISO 14971:2019 harmonizada com MDR : Commission Implementing Decision (EU) 2022/729 of 11 May 2022 amending Implementing Decision (EU) 2021/1195 as regards harmonised standards for quality management systems and for application of risk management to medical devices

ISO 14971:2019 harmonizada com MDR : Commission Implementing Decision (EU) 2022/729 of 11 May 2022 amending Implementing Decision (EU) 2021/1195 as regards harmonised standards for quality management systems and for application of risk management to medical devices

  COMMISSION IMPLEMENTING DECISION (EU) 2022/729 of 11 May 2022 amending Implementing Decision (EU) 2021/1195 as regards harmonised standards for quality management systems and for application of risk management to medical devices   THE EUROPEAN COMMISSION,...

New revision of the EUDAMED Economic Operator user guide, v2.7.

New revision of the EUDAMED Economic Operator user guide, v2.7.

The EU EC have just released a new revision of the EUDAMED Economic Operator user guide, v2.7. How economic operators can use the actor registration module – concept, registration, management, access and mandates.    EUDAMED is the IT system developed by the...

ICH guideline E8 (R1) on general considerations for clinical studies

ICH guideline E8 (R1) on general considerations for clinical studies

This is an umbrella guidance, and this update/modernization includes important concepts to support and implement other requirments, like quality risk management (from ICH E6). It introduces Quality by Design and Critical to Quality Factors, as appropriate and flexible...

UDI Devices – User guide EUDAMED v2.7 .  April 2022

UDI Devices – User guide EUDAMED v2.7 . April 2022

The new MDR 2017/745 and IVDR 2017/746 EU regulations introduce an EU identification system for medical devices based on a Unique Device Identifier (UDI) and require that manufacturers of medical devices submit the UDI/Device information of all devices/products that...

NEWS FDA DRAFT GUIDANCE ON CYBERSECURITY:

Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions Draft Guidance for Industry and Food and Drug Administration Staff APRIL 2022   The need for effective cybersecurity to ensure medical device functionality and...

New ICHQ14 guideline : ANALYTICAL PROCEDURE DEVELOPMENT Q14

New ICHQ14 guideline : ANALYTICAL PROCEDURE DEVELOPMENT Q14

New ICHQ14 guideline is proposed to harmonise the scientific approaches of analytical procedure development, and to provide the principles relating to the description of analytical procedure development process. ICHQ14 is intended to improve regulatory communication...

Committee on Herbal Medicinal Products (HMPC): work plan 2022

Committee on Herbal Medicinal Products (HMPC): work plan 2022

The Committee on Herbal Medicinal Products (HMPC) is the European Medicines Agency's (EMA) committee responsible for compiling and assessing scientific data on herbal substances, preparations and combinations, to support the harmonisation of the European market. The...

5ª Edição da formação GMP para CANABIS MEDICINAL : “Excelente”

5ª Edição da formação GMP para CANABIS MEDICINAL : “Excelente”

Mais uma edição da formação sobre as  GMP para Canábis , uma  formação com todos os pontos principais das GMP, interativa e com  casos práticos que apoiam a aplicação de conhecimentos técnicos teóricos e dos conceitos das boas práticas, conduzida pelo reconhecido...

Final Annex 21 published

Final Annex 21 published

The Rules Governing Medicinal Products in the European Union Volume 4 EU Guidelines for Good Manufacturing Practice for Medicinal Products for Human and Veterinary Use   The final version of Annex 21 to the EU-GMP Guidelines ("Importation of medicinal products")...

PRIME enables earlier availability of life-changing medicines

PRIME enables earlier availability of life-changing medicines

PUBLISHED BY EMA News 03/03/2022 EMA’s PRIority Medicines (PRIME) scheme has had a positive impact on the authorisation of new medicines that address patients’ unmet medical needs. The time to marketing authorisation was reduced for medicines that benefitted from...

Regulation on EMA’s extended mandate becomes applicable

Regulation on EMA’s extended mandate becomes applicable

News 01/03/2022 The regulation reinforcing EMA’s role in crisis preparedness and management of medicinal products and medical devices becomes applicable as of today, 1 March 2022. It puts some of the structures and processes established by EMA during the COVID-19...

Disponíveis FAQ sobre o novo Regulamento de Dispositivos Médicos

Disponíveis FAQ sobre o novo Regulamento de Dispositivos Médicos

O site do Infarmed disponibiliza, agora, um conjunto de “perguntas frequentes” sobre o novo Regulamento de Dispositivos Médicos. Organizadas por capítulos, pretendem apoiar os diferentes intervenientes deste setor na aplicação do Regulamento (UE) 2017/745, do...