International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH)

International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH)

The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) is unique in bringing together the regulatory authorities and pharmaceutical industry to discuss scientific and technical aspects of drug registration. Since its inception in 1990, ICH has gradually evolved, to respond to the increasingly global face of drug development. ICH's mission is to achieve greater harmonisation worldwide to ensure that safe, effective, and high quality medicines are developed and registered in the most resource-efficient manner. Harmonisation is achieved through the development of ICH guidelines via a process of scientific consensus with regulatory and industry experts working side-by-side.

The ICH Assembly brings together all Members and Observers of the ICH Association as the overarching governing body of ICH. The EDQM is an observer of the ICH Association and contributes to the development of ICH guidelines.
Medicines and Medical Devices Agency is an observer of the ICH Association since 14.06.2018.
Quality Guidelines:
Harmonisation achievements in the Quality area include pivotal milestones such as the conduct of stability studies, defining relevant thresholds for impurities testing and a more flexible approach to pharmaceutical quality based on Good Manufacturing Practice (GMP) risk management.
Safety Guidelines:
ICH has produced a comprehensive set of safety Guidelines to uncover potential risks like carcinogenicity, genotoxicity and reprotoxicity.
Efficasy Guidelines:
The work carried out by ICH under the Efficacy heading is concerned with the design, conduct, safety and reporting of clinical trials.
The ORDER of the MMDA nr. A07.PS-01.RG.04-111 DIN 02.05.2018 „Cu privire la aplicarea în practică a Ghidurilor ICH în domeniul calității medicamentelor„

Links:

https://www.ich.org/products/guidelines/quality/article/quality-guidelines.html

https://www.ich.org/products/guidelines/safety/article/safety-guidelines.html

https://www.ich.org/products/guidelines/efficacy/article/efficacy-guidelines.html

http://amed.md/sites/default/files/Legislatie/Acte%20emise%20de%20AMDM/111%20din%2002.05.2018.pdf

http://www.ich.org/about/organisation-of-ich/assembly/observers.html

https://www.edqm.eu/en/international-harmonisation-614.html