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Medicinal products - Latest updates (313)
RSSQuestions 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
Regulation (EU) 2019/6 of the European Parliament and of the Council of 11 December 2018 on veterinary medicinal products and repealing Directive 2001/82/EC
Questions and Answers Document – Regulation (EU) 536/2014 – Version 5 (January 2022)
New template - Compliance with applicable rules for biological samples
European Health Union: new rules to improve clinical trials in the EU
Agenda - 98th meeting of the Pharmaceutical Committee (20 January 2022)
Accelerating clinical trials in the EU (ACT EU) - Delivering an EU clinical trials transformation initiative
Commission Implementing Regulation (EU) 2022/20 on setting up the rules and procedures for the cooperation of the Member States in safety assessment of clinical trials