RESOURCES LIBRARY
Whitepapers, Guidelines, Legislação, Artigos
THE PHARMACEUTICAL INDUSTRY: A KEY ASSET TO SCIENTIFIC AND MEDICAL PROGRESS
The Pharmaceutical Industry in Figures. Key Data 2017 by .EFPIA (The European Federation of Pharmaceutical Industries and...
Principles of Labeling for Medical Devices and IVD Medical Devices
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...
Unique Device Identification system (UDI system) Application Guide
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...
Implementação dos dispositivos de segurança nos medicamentos de uso humano nos hospitais do SNS
Circular Normativa Conjunta n.º 01/ACSS/INFARMED/SPMS: Implementação dos dispositivos de segurança nos medicamentos de uso humano nos hospitais do...
Technical document on cosmetic claims
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
Manufacture of Sterile Medicinal Products : ANNEX 1 EU GMP VOL IV
Updated: ICH Q12: A Framework for Managing Post-Approval CMC Changes
The US Food and Drug Administration (FDA) made available an International Council for Harmonisation (ICH) draft guidance on technical and regulatory considerations for pharmaceutical lifecycle management.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...
DATA INTEGRITY REFERENCES
REFERÊNCIAS: .-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...
ISO 13485 :2016 Versão para download
A norma ISO 13485 tem como objetivo garantir o cumprimento dos requisitos legais, a gestão dos riscos e a manutenção dos processos de projecto, produção e distribuição de dispositivos médicos. A Formiventos disponibiliza a nova versão para download : Medical devices...
PGEU Best Practice Paper: Pharmacovigilance and Risk Minimisation
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...
Manual on Borderline and Classification in the Community regulatory framework for medical Devices
The European Commission released an update to its manual on classifying "borderline" medical devices featuring clarifications as to the medical device status and classification of on twelve additional types of products. Download PDF rendition...
The European regulatory system for medicines. A consistent approach to medicines regulation across the European Union
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
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...
DATA INTEGRITY REFERENCES
.-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...
MHRA GMP Data Integrity Definitions and Guidance for Industry
MHRA GMP Data Integrity Definitions and Guidance for Industry
Data Integrity and Compliance With CGMP
Data Integrity and Compliance With CGMP
Harmonised Technical Guidance for ASMF Submissions in eCTD format in the EU
Guidance for ASMF holders and MA holders on Providing Regulatory Information in Electronic Format
Guideline on setting health based exposure limits for use in risk identification in the manufacture of different medicinal products in shared facilities
Guideline on setting health based exposure limits for use in risk identification in the manufacture of different medicinal products in shared facilities
Looking to the Future in Regulatory Affairs
By Oliver Cox and Siegfried Schmitt, PhD Predicting the future is, of course, like gazing into a crystal ball; therefore, the reader is warned that the following is based in part on indicators from industry and the regulators, but mostly on personal considerations and...
Novo Quadro Regulamentar Europeu aplicável ao setor dos Dispositivos Médicos
O dia 5 de maio de 2017, foi publicado no Jornal Oficial da União Europeia o novo Quadro Regulamentar Europeu aplicável ao setor dos Dispositivos Médicos, nomeadamente: Regulamento (UE) 2017/745 do Parlamento Europeu e do Conselho, de 5 de abril de 2017, relativo aos...
Competence, Training, and Conduct Requirements for Regulatory Reviewers
This document applies to individuals performing regulatory reviews and making decisions associated with the regulatory review for IVD and non IVD medical devices, on behalf of Regulatory Authorities and/or their recognized CABs. This document recognizes the use of...
New rules for Novel Food
REGULATION (EU) 2015/2283 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 25 November 2015 .on novel foods, amending Regulation (EU) No 1169/2011 of the European Parliament and of the Council and repealing Regulation (EC) No 258/97 of the European Parliament and of...