Memorandum on quality control of preparation Biklood A.
Today, March 16, 2018, a significant event in the life of patients’ organizations and pharmaceutical industry representatives of Ukraine took place.
Charitable Foundation «Children with hemophilia», which was headed by Nina Astaforova, and president of the immunobiological pharmaceutical company Biopharma Konstantin Efymenko signed a memorandum about the creation of a working group for the constant control of the safety and quality of the medicine «BioСlot A» with the involvement of international organizations. The reason for signing the document was the patient and Charitable Fund’s «Children with hemophilia» (БФ «Діти з гемофілією») concern regarding the following factors:
1. The level of the active substance (factor VIII and the Willebrand factor) in «BioСlot A» drug manufactured by Biopharma company;
2. The quality of the raw material used for the production of «BioСlot A»;
3. Compliance with international standards and compliance with production technologies of «BioСlot A»;
4. Virological safety of «BioСlot A».
The memorandum provides for regular and open consultations between the representatives of the company «Biopharma» and the Charitable Foundation «Children with hemophilia».
In addition, the signatories agreed on conducting a check of the quality of the raw materials used in the manufacture of the drug «BioСlot A» , on the basis of the relevant independent EU laboratories, compliance with the technology of production of the medicinal product «BioСlot A», and their compliance with international standards, the level of active substance and the viral safety of «BioСlot A».
At the same time, by January 1, 2019, a joint working group should be set up at the expense of Biopharma and with the participation of international organizations (World Federation of Hemophilia / Federación Mundial de Hemofilia and
European Haemophilia Consortium) in order to introduce a permanent transparent system of public monitoring and quality monitoring (QA/QC) of raw materials, production and medicines of Biopharma company.
The memorandum also provides for an appeal to the Ministry of Health of Ukraine (Міністерство охорони здоров’я України) with a proposal to participate in the creation and implementation of the QA/QC system.
The parties also agreed to publish in public, all information, except confidential, which is related to the implementation of the memorandum. In addition, the signatories have shown that this Memorandum is open to the accession of any specialized institutions and organizations.