State Control of Medicines and Medical Devices in Russian Federation

Transcription

1 Federal Service for Surveillance in Healthcare State Control of Medicines and Medical Devices in Russian Federation Ph.D., Elena Astapenko The Head of the Department of organization of state control and registration of medical devices

2 Structure and Competences of Roszdravnadzor Federal Service for Surveillance in Healthcare (Roszdravnadzor) Central Office, including 8 Divisions Quality and safety control of healthcare practices 11 Federal laboratory complexes Control in the sphere of medicines circulation 80 Regional Offices Control of medical devices circulation

3 State Control System in the Sphere of Circulation of Medicines Functions of Roszdravnadzor in the sphere of circulation of medicines Licensing of pharmaceutical activity (licensing control) Federal state supervision in the sphere of circulation of medicines (includes quality control of medicines) Selective quality control of medicines Groups of drugs The elements of the system of state quality control of medicines Central apparatus of Roszdravnadzor and its territorial bodies Testing laboratories Unified information system The system of quality in organizations manufacturing medicines, wholesale and retail pharmaceutical organizations Information about the number of withdrawn drugs for the period months 2015 The number of withdrawn drugs months 2015 Insufficient drugs Drugs, withdrawn by the manufacturer Counterfeit of pharmaceutical substances and drugs, made from them Counterfeit drugs Counterfeit medicines Total

4 Federal State Budgetary Institution «Information and Methodological Center of Expertise, Stocking and Analysis of Medical Products Circulation» of Roszdravnadzor Volga Federal District 1 laboratory complex and 1 mobile lab (Kazan) North-West Federal District 1 laboratory complex and 1 mobile lab (Saint-Petersburg) Central Federal District 3 laboratory complexes (Moscow, Kursk, Tambov) 1 mobile lab (Moscow) Ural Federal District 1 laboratory complex and 1 mobile lab (Ekaterinburg) South Federal District, Crimean Federal District 2 laboratory complexes, 2 mobile labs (Rostov-on-Don, Simferopol) Far-East Federal District 1 laboratory complex and 1 mobile lab (Khabarovsk) North Caucasus Federal district 2 laboratory complexes (Stavropol, Gudermes) 1 mobile lab (Gudermes) Siberia Federal District 1 laboratory complex and 1 mobile lab (Krasnoyarsk)

5 Federal State Budgetary Institution «Information and Methodological Center of Expertise, Stocking and Analysis of Medical Products Circulation» of Roszdravnadzor Organizational department Analytical laboratory Microbiological laboratory Pharmacological laboratory Immunological laboratory (Krasnoyarsk, Moscow, Yaroslavl) Mobile laboratory 5

6 Organization of Random Control of Medicines Manufacturers and importers of medicines Roszdravnadzor s information system Forming of random control plan Submitting of lot and batches data for medicines entering the market Acquired processing information Forwarding of the task to Roszdravnadzor s regional offices Testing laboratories of Roszdravnadzor Roszdravnadzor s regional offices Medicines samples testing Selection of samples

7 Decision Making on the Results of Random Quality Control of Medicines Roszdravnadzor Collecting results of medicines testing Positive conclusion Negative conclusion Repeated negative conclusion Information is published at Roszdravnadzor web-site Decision to withdraw and destroy a lot. Information is published at Roszdravnadzor web-site Batch-to-batch control on three batches, at the laboratories of Roszdravnadzor Decision to remove from batch-to-batch control in case of positive results Inspection In case of GMP incompliance - suspension of application of a medicine till the correction of identified deficiencies

8 Improvement of Federal State Control (Supervision) in the Sphere of Circulation of Medicines Federal Law dated No 429-FZ On amendments to the federal law "On circulation of medicines (entered into force on the 1 July 2015) Selective quality control of medicines was implemented. (the order of Roszdravnadzor dated «About approval of the procedure for implementation of selective quality control of medicinal products for medical use») Amendments to pharmacovigilance arrangements Amendments to the Federal Law dated No 294-FZ «On the protection of rights of legal entities and individual entrepreneurs when exercising state control (supervision) and municipal control» Are not required: prior approval from prosecutors to the timing of unscheduled inspections of subjects of circulation of medicines, advance notification of legal entities and individual entrepreneurs about the beginning of the unscheduled inspection. The prosecution bodies are notified about an unscheduled inspections of subjects of circulation of medicines by submitting the relevant documents within three business days after the end of the specified unscheduled inspections.

9 The General Scheme of Participants and Flows in the System for Monitoring of the Civil Turnover of Medicines The monitoring of civil turnover of medicines from the manufacturer to the final consumer is provided: Way I: 1. Manufacture of a medicine 2. Wholesale trade 3. Retail trade, usage by hospitals Way II: 1. Manufacture of a medicine 2. Retail trade, usage by hospitals Medicine Retail Patient Way I Manufacture Distributor Distributor 2 N Distributor 1 Way II Hospital

10 Pangea Operation Control measures together with representatives of law enforcement and customs authorities Screening quality of medicines in mobile labs using non-destructive NIR spectrometry method Examination of questionable samples in the federal laboratory complexes Advisory and information support to participants of the operation Informational materials, list of counterfeit drugs and APIs and also information about installed signs of falsification

11 Definition of Medical Device in Russian Federation The Law 323-FZ dated The basis of health protection in the Russian Federation Article 38. Medical devices. Medical devices are any instrument, apparatus, appliances, equipment, materials and other devices used for medical purposes alone or in combination with each other as well as with other accessories required for use of these devices for their purpose, including special software and designed by the manufacturer for the prevention, diagnosis, treatment and rehabilitation of diseases, monitoring the state of the human body, for medical research, rehabilitation, replacement, changes of anatomical structure or physiological functions, prevention or termination of pregnancy, which function is not implemented by pharmacological, immunological, genetic or metabolic effects on the human body. Medical devices may be recognized as interchangeable if they are comparable in functionality, quality and technical characteristics and can replace each other. 11

12 Stages of Circulation of Medical Devices Technical trials Toxicity studies Clinical trials Utilization and disposal Expertise of quality, efficacy and safety Repairs Application, operation, including maintanance Roszdravnadzor Production Manufacturing Import, export Installation, adjustment Sales Transportation Storage

13 Methods of State Control of Circulation of Medical Devices Audits of the subjects of circulation of medical devices compliance with the rules of medical devices circulation approved by the Russian Ministry of Health Permissions for imports of medical devices for the purposes of state registration Monitoring of safety of medical devices

14 Functions of Roszdravnadzor s Subordinate Expert Organizations Expertise of quality, efficiency and safety of medical devices: for the purposes of registration of medical devices within the framework of control measures Conducting technical testing of medical devices Toxicological studies Monitoring the quality, effectiveness and safety of medical devices

15 Federal State Budgetary Institution All-Russian Scientific-research and Test Institute for Medical Engineering of Roszdravnadzor Testing laboratory of medical supplies and tools Technical tests laboratory of medical devices Testing laboratory of mobile complexes for medical purposes Testing laboratory of instruments and equipment for functional diagnostics and physiotherapy Testing laboratory of medical devices software Testing laboratory of instruments and apparatus for radiation diagnosis and therapy Testing laboratory of electromagnetic compatibility of medical equipment Testing laboratory of instruments and apparatus for medical laboratory tests Department of toxicology testing and research materials and medical devices Laboratory of microbiological researching in medical devices 15

16 Statistical Data on Identified Medical Devices months 2015 More than 62% relate to the following types: physiotherapy equipment diagnostic equipment in vitro reagent sets prosthetic and orthopedic devices medical clothing and protective equipment Substandard medical device units 9 months units Falsified medical device unit 9 months units

17 Improvement of Federal State Control (Supervision) in the Sphere of Medicines and Medical Devices Circulation Amendments to the Administrative Code of the Russian Federation Article Violation of the rules in the field of circulation of medical devices (since ) Article Circulation of falsified, counterfeit, substandard and unregistered medicines, medical devices and the turnover of falsified biologically active supplements (since ) Type of medicine or medical device Falsified medicine Falsified medical device Counterfeit medicine Counterfeit medical device Substandard medicine Substandard medical device Unregistered medicine Activity Manufacture, sale or import Sale or import Manufacture, sale or import Fines citizens thsd rubles officials thsd rubles individual entrepreneurs thsd rubles or up to 90 days legal entities 1-5 mln rubles or up to 90 days Amendments to the Criminal Code of the Russian Federation (since ): illegal manufacture of drugs and medical devices (Article ); circulation of counterfeit, substandard and unregistered medicines, medical devices and trafficking of falsified biologically active supplements (Article ); forgery of documents for medicines or medical devices, or forgery of the packaging of medicines or medical devices (article ) in a large size (more than 100 thousand rubles) imprisonment up to 12 years; fine up to 5 million rubles. deprivation of the right to engage in professional activities up to 10 years.

18 Federal Service for Surveillance in Healthcare Thank you for your attention! PhD., Astapenko E.M. Head of the Department of organization of state control and registration of medical devices