Module 5 Presentations

05/07/2024

Harmonization of GCP

International Conference (now Council ) on Harmonization ( ICH ) of Technical Requirements for Registration of Pharmaceuticals for Human Use, 1990 Partners: pharmaceutical industry + regulatory authorities Aims: • Agreement on interpreting and applying technical guidelines and requirements for product registration

• Standardize approaches and avoid duplication/repetition of clinical trials

• Assure comparable data and safeguard to protect public health

• Provide a unified standard for the European Union, Japan and United States of America to facilitate the mutual acceptance of the clinical data by regulatory authorities. • ICH GCP guideline was developed with consideration of the current good clinical practices in the EU, Japan, United States of America, as well those of Australia, Canada, the Nordic Countries and the World Health Organization.

The Organisation for Professionals in Regulatory Affairs

31

Further legislation development

• EudraLex - Volume 10 Clinical trials guidelines • European Directive 2001/20/EC on Clinical Trials • European Directive 2005/28/EC on GCP • European Directive 2003/94/EC for investigational medicinal products (IMP) for human use • Good Pharmacovigilance Practices • Regulation (EU) No 536/2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC • Implementing Regulation (EU) 2017/556 (GCP) • Delegated Regulation (EU) 2017/1569 (GMP) • EU Pharmaceutical Legislation Reform 2023

and many more…..

The Organisation for Professionals in Regulatory Affairs

32

16