RESOURCES LIBRARY

FDA expects that all data be reliable and accurate (see the “Background” section). CGMP regulations and guidance allow for flexible and risk-based strategies to prevent and detect data integrity issues. Firms should implement  meaningful and effective strategies to...

Data is the most crucial asset in any clinical trial and is used to ultimately drive the decision-making process related to the development candidate. Therefore, for any sponsor, paying close attention to the data management aspects of clinical operations should...

Clarifications of UDI related responsibilities in relation to Article 16 of the Medical Device Regulation 2017/745 and the In-Vitro Diagnostic Medical Devices Regulation 2017/746

UDI Assignment to Medical Device Software

New regulations Guidance document to assist stakeholders in implementing the Medical Devices Regulations. MDCG 2018-3 Guidance on UDI for systems and procedure packs MDCG 2018-4 Annex: UDI database Definitions/Descriptions and formats of the UDI core elements for...

This e-book has been designed as an introduction to electronic informed consent (eConsent) in clinical trials for those researchers considering making the switch from traditional paper-based processes. The Essential Guide To Electronic Informed Consent

An industry survey conducted by KPMG and the Regulatory Affairs Professionals Society (RAPS) found little familiarity with the European Union’s new Medical Device Regulation and its requirements that take full effect in May 2020. read the survey  :THE RACE TO EU MDR...

Este documento pretende informar sobre o entendimento do INFARMED, I.P. relativamente às questões mais colocadas pelas entidades sobre a implementação dos dispositivos de segurança nas embalagens de medicamentos de usos humano. Download: Perguntas e respostas sobre o...

INFARMED Circular Informativa N.º 137/CD/100.20.200 Data: 21/09/2018 Novos Regulamentos de DM e DIV - orientações da Comissão Europeia para fabricantes      

This free brochure gives an overview of the standard and how it can help organizations implement an effective risk management strategy. Download

The Pharmaceutical Industry in Figures. Key Data 2017   by .EFPIA (The European Federation of Pharmaceutical Industries and Associations)

The purpose of this IMDRF guidance is to provide globally harmonized labeling principles for medical devices and IVD medical devices and support the IMDRF Essential Principles of Safety  and Performance. Specifically, this document provides guidance on the content of...

The IMDRF UDI Guidance (IMDRF/WG UDI/N7Final:2013) provides a framework for the regulatory authorities that intend to develop their UDI systems in a globally harmonized approach. This UDI system Application Guide is to be used as a supplement to the IMDRF UDI Guidance...

The purpose of this document is to provide guidance for the application of Commission Regulation (EU) No 655/2013 laying down common criteria for the justification of claims used in relation to cosmetic products. Technical document on cosmetic claims Agreed by the...

Manufacture of Sterile Medicinal Products : ANNEX 1 EU GMP VOL IV

The US Food and Drug Administration (FDA) made available an International Council for Harmonisation (ICH) draft guidance on technical and regulatory considerations for pharmaceutical lifecycle management. Q12 Technical and Regulatory Considerations for Pharmaceutical...

This best practice paper outlines the evolution of pharmacovigilance in Europe, particularly in the context of the fifth anniversary of the 2012 EU pharmacovigilance legislation and recent developments in the field. Additionally, this paper describes the varied role...

This booklet explains how the European regulatory system for medicines operates. It describes how medicines are authorised and monitored in the European Union (EU) and how the European medicines regulatory network—a partnership between the European Commission, the...

Regulamento de Execução (UE) 2017/2185 da Comissão, de 23 de novembro de 2017, relativo à lista de códigos e respetivos tipos de dispositivos destinada a especificar o âmbito da designação dos organismos notificados no domínio dos dispositivos médicos, nos termos do...

.-EMA: Questions and answers: Good manufacturing practice - Data Integrity Section .-FDA: FDA Data Integrity Guidance .-MHRA: MHRA Data Integrity Definitions and Guidance .-PIC/S: PIC/S Guidance .-WHO: WHO Guidance

Guidance for ASMF holders and MA holders on Providing Regulatory Information in Electronic Format