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Use of Electronic Records and Electronic Signatures in Clinical Investigations Under 21 CFR 11 Part - Questions and Answers - Guidance for Industry

This document provides guidance to sponsors, clinical investigators, institutional review boards (IRBs), contract research organizations (CROs), and other interested parties on the use of electronic records and 21 CFR part 11 electronic Records; Electronic Signatures.


Good Pharmacovigilance Practices (GVP)

Good pharmacovigilance practices (GVP) are a set of Measures drawn up to Facilitate the performance of pharmacovigilance in the European Union (EU). GVP apply to marketing permission-holders, the European Medicines Agency and medicines regulatory autorités in EU Member States. They cover medicines authorized centrally via the Agency as well as medicines authorized at national level.

Good Pharmacovigilance Practices (GVP)

Implementation strategy of ICH guideline Q3D

The purpose of this paper is to address specific considerations to enable the practical implementation of ICH Guideline for Q3D Elemental Impurities in the European Union. It is Intended to Provide Guidance for Applicants / MAHs, drug product, drug substance and vehicle manufacturers, as well as regulators. In addition to new applications, it will aussi apply to changes to Existing authorized medicinal products.


Regulations European Commission 2017 / 556 Inspection Procedures for Good Clinical Practice

This Regulation applies to inspections on:

a) clinical trials in the EU, including the clinical trial sites in connection with these tests, but outside of the Union;

b) clinical trials mentioned in the requests for clinical trial authorization in accordance with Article 25, 5 paragraph of Regulation (EU) Noo 536 / 2014; c) clinical trials conducted in third countries and mentioned in the marketing authorization application in the EU.

Regulations European Commission 2017 / 556 Inspection Procedures for Good Clinical Practice

Scientific guidelines with recommendations SmPC

The European Medicines Agency HAS released a detailed list of all relevant guidelines with SmPC (Summary of Product Characteristics) recommendations have an overview and media for marketing permission holders.


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Commit to share
Transmit and progress together
Promoting innovation

The A3P Association is a major player in the pharmaceutical and biotechnology industry.
Created in 1986, it contributes to the good development of the production of medicines and clean and sterile equipment, it runs a network of professionals 21 000, manufacturers and suppliers, as part of International Congress and technical days.

It now has over 1700 members who share their technical experience, scientific and regulatory.

More info on video (Versiongb here )

  group    administrators A3P
& Project Managers

letter   newsletter A3P
BROWSER A3P is a tool comprising the majority of links to texts, guides, regulatory documents and websites for the pharmaceutical, biotechnology and biomedical.
  • GMP & Guides

  • Country Sites

  • Regulatory Sites

  • Pharma areas

  • other Sites

   version 1.00                                                                                                               Youtube   linkedin