Medicinal products - Latest updates

Revision - Manufacture of Sterile Medicinal Products

Summary record - 99th meeting of the Pharmaceutical Committee (11 May 2022)

Questions and answers - Complex clinical trials

Questions and Answers Document – Regulation (EU) 536/2014 – Version 6.1, May 2022

Q&A on the interface between Regulation (EU) 536/2014 on clinical trials for medicinal products for human use (CTR) and Regulation (EU) 2017/746

Agenda - 99th meeting of the Pharmaceutical Committee (11 May 2022)

Questions and Answers Document – Regulation (EU) 536/2014 – Version 6 April 2022)

Summary record - 98th meeting of the Pharmaceutical Committee (20 January 2022)

Presentations and recording - HPP webinar: “Political and legal issues linked to financing the development of pharmaceuticals all along their life-cycle” (03 March 2021)

Eudralex Volume 4 - EU Guidelines for Good Manufacturing Practice for Medicinal Products for Human and Veterinary Use

HPP Webinar - Political and legal issues linked to financing the development of pharmaceuticals all along their life-cycle (3 March, 15.00 - 16.30 CET)

Updated - Guideline on the requirements to the chemical and pharmaceutical quality documentation concerning investigational medicinal products in clinical trials

Updated - Guideline on the requirements for quality documentation concerning biological investigational medicinal products in clinical trials

Updated document - Guidance on the management of clinical trials during the COVID-19 (Coronavirus) pandemic

A summary report and replies to the public consultation on the revision of the general pharmaceutical legislation published on have your say

Update - Guideline on the requirements to the chemical and pharmaceutical quality documentation concerning investigational medicinal products in clinical trials

Update - Guideline on the requirements for quality documentation concerning biological investigational medicinal products in clinical trials

Commission Implementing Regulation (EU) 2021/1280 on good distribution practice for active substances used as starting materials in veterinary medicinal products

Commission Implementing Regulation (EU) 2021/1248 on good distribution practice for veterinary medicinal products in accordance with Regulation (EU) 2019/6