Biomedical Cell Products: Working By the Rules
Biomedical Cell-Based Products: Working By the Rules.
A draft of law of RF MoH “On Approval of Rules of Good Practice of Operating Biomedical Cell-Based Products” has been submitted for public discussion.
Until recently there was no document regulating circulation of biomedical cell-based products in Russia. Now it will be available. According to the Federal Law of the Russian Federation of 23.06.2016 No 180-FZ “On biomedical cell-based products” the Ministry of Health has developed the rules regulating processing of these, which will be the basis of the legislative base for creation innovative biomedical cell-based products used in regenerative medicine.
The rules include Good Manufacturing Practice of Biomedical Cell-Based Products and Rules of Preclinical Trials of Biomedical Cell-Based Products. These regulate rules of establishment and management of production quality systems for biomedical cell-based products, quality assurance systems.
The project regulates risk management, efficacy assessment, general and special requirements to personnel and consultants, and specifies requirements to design, positioning and construction of facilities and units to be operated in production and quality control of biomedical cell-based products.
The draft is available at: http://regulation.gov.ru/p/56230.
Public discussion of the document will be completed on November 7, 2016.