- Published: Tuesday April 11 2017 11: 45
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.
- Published: Tuesday April 11 2017 10: 45
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.
- Published: Tuesday April 11 2017 08: 45
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.
- Published: Tuesday April 11 2017 09: 45
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.
Concept paper on the need for revision of Note for guidance on quality of water for pharmaceutical use (H + V)
- Published: Monday March 20 2017 08: 45
The current guideline needs to be updated to Reflect imminent exchange in European Pharmacopoeia. The text of guideline needs to be updated to take into account manufacturing practices using methods --other than distillation for Producing water of injectable quality and therefore the deletion of the monograph Water, highly purified. A new Ph. Eur. monograph "Water for preparation of extracts" (2249) est aussi disponible.