PLASMA FRACTIONATION MARKET, REGULATORY ISSUES, EXISTING PROBLEMS AND WAYS OF THEIR SOLUTION

REGULATORY ISSUES Federal Law No. 125-FZ of June 20, 2012 «On the donation of blood and its components». Order No. 183n. dated April 2, 2013 of the Ministry of Health of the Russian Federation «On the approval of the rules for the clinical use of donated blood and (or) its components». GMP rules approved by the Order No. 916 dated June 14, 2013 of the Ministry of Industry and Trade of Russia (Appendix No.14 - Production of medicinal products derived from donated blood or plasma). Order of the Government of Russia No. 797 dated June 22, 2019 «On approval of guidelines of collection, storage, transportation, and clinical use of donated blood and blood components» (Prior document - Technical Regulation «On the requirements to the safety of blood and its products, blood replacing solutions and technical means used in the transfusion and infusion therapy» approved by the Order of the Government of Russia No. 29 dated January 26, 2010). State Pharmacopoeia GF XIII-XIV approved by the Ministry of Health of the Russian Federation for the implementation of the Law No. 61 – FZ (FA «Human plasma for fractionation»).

EXISTING PROBLEMS Raw material (plasma for fractionation) shortage. Lack of differentiated requirements for plasma taking into consideration its various uses. Inflated requirements for plasma for fractionation. Necessity of Rh-factor analysis. Necessity of long-term quarantine plasma storage. Inability to use (processing) fresh frozen plasma. Inflated requirements for donors in case of further using plasma for processing. Lack of standard of care defining different ways of using components or types of plasma.

PROPOSALS Administering functions centralization in a single federal executive body - the Ministry of Industry and Trade of Russia. Separation of functions of preparation and processing of blood. Standardization of raw material and processing requirements in accordance with GMP. Blood component legal regulation differentiation in accordance with use. Fresh frozen plasma quarantine storage reducing. Cancellation of plasma for fractionation quarantine taking into account the need for viral inactivation. Selectivity application in the use of blood products based on the planned treatment activities.