Tag: GCP

Good clinical practice (GCP) is an international quality standard that is provided by ICH, an international body that defines a set of standards, which governments can then transpose into regulations for clinical trials involving human subjects. A similar guideline for clinical trials of medical devices is the international standard ISO 14155, which is valid in the European Union as a harmonized standard. These standards for clinical trials are sometimes referred to as ICH-GCP or ISO-GCP to differentiate between the two and the lowest grade of recommendation in clinical guidelines

EMA turns down approval of AB Science’s ALS drug

AB Science announced that the Committee for Medicinal Products for Human Use has adopted a negative opinion for the marketing authorization of masitinib in the treatment of adult patients with Amyotrophic Lateral Sclerosis (ALS).

Clinical sites of Karaganda Medical University meet GCP standard

Ministry of Health of the Republic of Kazakhstan issued a certificate of compliance with the Good Clinical Practice to two clinical sites of RSE on REM “Karaganda State Medical University”

Russia elaborated the GCP Rules for Biomedical Cell Products

The Ministry of Health of the Russian Federation published its Order “On the Adoption of the Rules of Good Clinical Practice for Biomedical Cell Products.”