30.Jan.2013

Russian government issued a draft plan of changes into the Federal Law # 61 “On Circulation of Medicines”

Russian government issued a draft plan of changes which might be introduced into the Federal Law # 61 “On Circulation of Medicines”.
Russian government issued a draft plan of changes which might be introduced into the Federal Law # 61 “On Circulation of Medicines”. This Federal Law regulates relations arising in connection with circulation, i.e. development, preclinical testing, clinical trials, expert examination, evaluation, state registration, standardization and quality control, manufacture, compounding, storage, transportation, import into the Russian Federation, export from the Russian Federation, advertising, dispensation, distribution, transfer, use and destruction of medicines. This Federal Law establishes the priority of the state control of safety, quality and efficacy of medicines in the process of their circulation. The draft plan of the changes gives definition of the following terms which are not defined in any document: 
  1. Pharmaceutical substance- medicinal product which contains one or several active ingredients of biological, biotechnology, mineral, chemical origin; which has pharmaceutical activity; which is used for drug manufacturing and; which defines drug efficacy. 
  2. Orphan drug- medicinal product aimed at pathogenetic treatment of rare (orphan) diseases. Pathogenetic treatment is a treatment aimed at disease development mechanism. 
  3. Biologic drug- medicinal product including immunobiological drugs, drugs derived from blood or blood component, drugs created by biologic processes (technologies and methods), gene therapy and allergenic somatic cell therapy, which have active ingredients of biologic origin. 
  4. Reproduced drug- medicinal product which has the same qualitative and quantative composition of active ingredients in the same dosage form that is used in the original drug, which came into circulation not violating intellectual property rights of the original drug. 
  5. Comparator drug- medicinal product used to determine quality, efficacy and safety of the reproduced drug in case a relevant original drug is not used in circulation. 
  6. Biosimilar drug- biologic medical products which is similar to the original biologic drug in terms of manufacturing technology, pharmaceutical substance (combination of pharmaceutical substances), drug dosage, drug indication, and which went into circulation not violating intellectual property rights of the original drug. 
  7. Interchangeable drug- medicinal product which is not a biological drug, which has proven therapeutic equivalence with the original drug or comparator drug,which is used in the same indications, which has the same qualitative and quantative composition of active ingredients, drug dosage, dose and route of administration, if the original drug is not used in circulation. 
  8. Drug developer- a company which owns the rights of drug pre-clinical, clinical study results and/or production technology of the medicinal product. 
  9. Bioequivalence study- a type of clinical trials conducted to determine the rate of absorption and excretion of the pharmaceutical substance and the quantity of the pharmaceutical substance reaching the systemic blood flow, the results of which allow drawing an inference of bioequivalence of a certain dosage form and dose of a generic medicinal product to the originator medicinal product or comparator drug. 
  10. Production facility- a separate production complex which is aimed at performing partial or full drug development process of a medicinal product. 
  11. Registration certificate holder- a legal body which applied for drug registration and which received a registration certificate. 
  12. Grouping name of a medicinal product- name of the medicinal product used to group medicinal products under one name in accordance with active ingredients composition, which have no International Nonproprietary Name. 
The federal executive bodies are authorized with additional power including: 
  1. To approve the list of interchangeable drugs, 
  2. To form the procedure of approving the list of interchangeable drugs, 
  3. To maintain the list of interchangeable drugs, 
  4. To maintain the registry of instruction of use for interchangeable drugs, 
  5. To affirm the rules for rational choice of medicinal products name,
  6. To form the rules of the procedure for draft designs of drug packages, 
  7. To form the rules of the procedure for instructions for use of the medicinal product, 
  8. To form the list of dosage forms,
  9. To issue permits to import medicinal products in Russia.
The draft determines the procedure of expertise of the medicinal product, ethical expertise and the procedure of registration dossier preparation. The document determines the procedure of prices for medicinal products which are listed in Vital and Essential Medicines List. The draft also stipulates new state registration fees. 
This draft is to be discussed by the experts.