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.

2023年9月29日 · Updated document - Questions & Answers : Clinical Trials Regulation (EU) No 536/2014 . 15 JANUARY 2025; regulation5362014_qa_en.pdf. English (1.68 MB - PDF)

The CMC section of an EU IMPD: Considerations for US sponsors Author John Watkins, Associate Director, Regulatory Aff airs, PPD. Keywords Chemistry, manufacturing and controls (CMC); Clinical trial application (CTA); European Medicines Agency (EMA); Grounds for non-acceptance (GNAs); Investigational medicinal product

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.

The CMC sections of a US application disclose every possible product flaw by presenting the max- imum amount of available data. In contrast the European quality part focusses on identifying the

As one of the earliest foreign trade companies established in New China, CMC was born to be international. Since the 1980s, CMC has vigorously developed international engineering contracting business and become a vital constructor, investor and operator in the fields

2013年9月30日 · First, an overview of regulations, guidelines and events, impacting quality requirements of IMPs, will be presented together with a brief summary of the two procedures currently available for submission of CTAs in the EU. We will then focus on some of the CMC topics requiring special attention when preparing a dossier for a biological product ...

2022年1月31日 · European Union (EU) pharmaceutical legislation known as the Clinical Trials Regulation entered into application on 31 January 2022. It aims to ensure the EU offers an attractive and favourable environment for carrying out clinical research on a large scale, with high standards of public transparency and safety for clinical trial participants.

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. The Forum explores critical topics that define the biotech industry’s challenges and emphasizes CMC issues across a product's lifecycle.