This guidance addresses the documentation on the chemical and pharmaceutical quality of investigational medicinal product dossier containing chemically defined drug substances, synthetic peptides, herbal substances, herbal preparations and chemically defined radio-active/radio-labelled substances to be submitted to the competent authority for ap...

The following guideline is to be seen in connection with Regulation (EU) No. 536/2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC, which came into force on June 20, 2014.

Guidelines reflect a harmonised approach of the EU Member States and the Agency on how to interpret and apply the requirements for the demonstration of quality, safety and efficacy set out in the Community directives.

Since the 1980s, CMC has vigorously developed international engineering contracting business and become a vital constructor, investor and operator in the fields

News announcement 29 September 2023 Directorate-General for Health and Food Safety 1 min read Updated document - Questions & Answers : Clinical Trials Regulation (EU) No 536/2014

EU IMPD: Considerations for US sponsors Author John Watki. ate Director, Regulatory Af airs, PPD. Keywords Chemistry, manufacturing and controls (CMC); Clinical trial application (CTA); European Medicines Agency (EMA); Grounds for non-acceptance (GNAs); Investigational medicinal product dossier (IM.

The CMC Strategy Forum Europe is a leading scientific meeting that convenes regulatory, industry, and academic experts to address emerging CMC issues in biotechnology through open, transparent workshops. The Forum explores critical topics that define the biotech industry’s challenges, emphasizing CMC issues across a product's lifecycle.

2024年10月8日 · The CMC Strategy Forum Europe is a leading scientific meeting that convenes regulatory, industry, and academic experts to address emerging CMC issues in biotechnology through open, transparent workshops.

A significant part in European CMC writing therefore is the abstracting and minimizing data. resenting the max-imum amount of available data. In contrast the European quality part focusses on identifying the critical characteristics of th

Since clinical trials will often be designed as multi -centre studies, potentially involving different Member States, it is the aim of this guideline to define harmonised requirements for the documentation to be submitted throughout the European Union.