According to rules established in the Russian Federation, new vaccines intended for routine clinical use should not be of a lesser quality than similar products already approved by the national control laboratory, the L.A. Tarassevich State Research Institute for the Standardization and Control of Medical Biological Preparations.
Vaccine quality specifications must be established during the preclinical and clinical trial stages of development and cover a range of parameters. Data concerning all substances used in the production process, purification of vaccine antigen and formulation should also be provided. Substances used in the production of a vaccine must be approved by the Pharmacological Committee of the Russian Federation or the developer should present data showing the lack of toxicity of the substances in question.
Details of all elements which may affect the result of control tests are also expected, as well as of the tests themselves. This would include baseline data on the characteristics of animals, details of the experimental techniques and methods of statistical data processing. The reliability of measuring devices and the quality of reagents and other materials should also be monitored.
For licensing, the developer submits a license submission document to the National Control Laboratory. This describes the general characteristics of the preparation and methods for its quality control. It also contains the results of preclinical or clinical testing. Evaluation is carried out by the L.A. Tarassevich State Research Institute and by the Commission on Medical Immunobiological Preparations, Disinfectants and Cosmetics. The Tarassevich State Research Institute submits its report to the Commission which in turn makes recommendations to the Pharmacopoeial Committee of the Ministry of Health of the Russian Federation which takes the final decision.
Clinical trials may be carried out by the developer only when approved by the Scientific Council of the Tarassevich State Research Institute and the Commission. In addition, state (filed) trials are also carried out but only after approval of the report on pilot trials in limited groups. State trials are carried out by independent specialists who did not participate in the development, nor previous clinical trials, of the preparation.
The former USSR and later the Russian Federation, has been self-sufficient in vaccines and most biologicals. Although great attention was paid to quality control and quality assurance conditions by the National Control Authorities, shortage of funding over many years means that many facilities now require modernization and equipment needs upgrading.
Much of the regulatory framework already in place for traditional biologicals will apply to the development and licensing of biotechnology-derived medicines. The main challenges biotechnology production for Russia are the following.
1. Upgrading of quality assurance measures by reconstruction and renovation of establishments and facilities in order to fully meet modern GMP requirements.
2. Introduction of new automated and computerized equipment.
3. Recruitment of highly-qualified engineers for maintaining production and control of equipment.
4. Development of new Russian regulatory documents to strengthen the National Control Authorities.
5. Application of strict penalties to manufacturers violating laws and regulations involved with the production and distribution of biologicals.
6. Modernization of facilities and upgrading of equipment at the Tarassevich Institute for Standardization and Control of Medical Biological Preparations to enable it to carry out the task of assuring the quality of biologicals in the Russian Federation.
Russian experience in regulatory activities has shown that the requirements, standards, reference materials and other publications of the Biologicals Unit of WHO are extremely helpful to the national control authorities. Personnel involved in the standardization and control of biologicals greatly appreciate the assistance provided by WHO through its Biologicals Unit and look forward to continued future collaboration.
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