Russia elaborated the GCP Rules for Biomedical Cell Products

| By | Clinical Trials, GCP
0
2056

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.”

The Rules of Good Clinical Practice for Biomedical Cell Products regulate the relations in planning, organizing, implementing, monitoring, auditing, documenting the clinical trials of biomedical cell products involving the participation of humans as a subjects of clinical trials, analyzing the data, and presenting the results of clinical trials that ensure the reliability and accuracy of obtained data and presented results, as well as the protection of rights, health and confidentiality of personal data of patients in the clinical trials.

GOST R 52379-2005 “Good Clinical Practice” may be used for conducting the clinical trials of biomedical cell products together with these Rules in part not contrary to these Rules.

VIArussian version
SHARE
GMP news
Pharmaceutical industry News and events. Technology transfer and contract manufacturing of medicines.