Interconnection of good practices: from development to distribution Romanov Boris Konstantinovich, PhD., Deputy Director for Science of FSBI «Scientific Centre for Expert Evaluation of Medicinal Products» of the Ministry of Health of the Russian Federation Krasheninnikov Anatoly Evgenievich, PhD, ANO «National Pharmacovigilance Research Center» CEO, RQA and ISoP member

Good Practice Correlation Identify drug quality problems GVP GMP GDP GCP Monitoring the effectiveness and safety of drugs Planning, assessment and control of the safety level of the investigated drugs Additional Clinical trials

Pharmacovigilance Pharmakon Vigilare Pharmaco vigilance Vigilare‘ (vigilance) Medical institutions Pharmacy organizations Population Drug product manufacturer / MAH Distributors

Principles of pharmacovigilance system organized by Marketing Authorization Holder Principle of independence; Principle of continuity; Principle of the quality; Principle of involvement of management, staff, contractors; Principle of completeness of safety information collection; Principle of assistance; Principle of social and legal responsibility; Principle of resource availability; Principle of scientific evaluation; Principle of interaction; Principle of documentation; Principle of listening; Principle of improvement and development

The main normative legal acts in the field of post-registration pharmacovigilance in Russia (in part of special legislation) Guidelines on good pharmacovigilance practices of Eurasian Economic Union approved by Council’s decision of the Eurasian Economic Commission No.87 dated 03 November 2016 (entered into force 06.05.2017); Federal Law No.61-FZ «On the circulation of medicinal products» dated 12 April 2010 (Article 64 – «Pharmacovigilance», Article 18. «Submission and Review of Applications for State Registration of Medicinal Products for Medical Use»); Order of Roszdravnadzor No.1071 dated 15 February 2017 «On approval of the pharmacovigilance procedure»; Order of The Ministry of Health of the Russian Federation No.777 dated 14 November 2018 «On the endorsement of the procedure for suspension of use of the medicine for medical application»

Classification of risks of Marketing Authorizations Holders Acceptable risk   Critical risk Catastrophic risk Requests from regulatory authorities to confirm the availability of a pharmacovigilance system at the enterprise (Master-file, periodic safety update report, risk management plan, etc.); Amendments to the instructions for medical use; Changes to the clinical trial protocol; Suspension of clinical trials Administrative liability; Conducting of additional safety trials and effectiveness of the drug; Implementation of additional security monitoring measures; Suspension / withdrawal of drugs from circulation (para.2 art. 65 FZ «On the circulation of medicinal products») Cancellation of state marketing authorization of a drug (para. 9 art. 34 FZ «On the circulation of medicinal products»); Criminal liability (Criminal Code of the Russian Federation, Article 238. Production, Storage, Carriage or Sale of Goods and Products, Fulfillment of Works or Rendering of Services Which Do Not Meet Safety Standards)

Basic elements of pharmacovigilance system

Sources of adverse drug reactions information

Drug product manufacturers Main difficulties of pharmacovigilance system implementation by subjects of pharmaceutical market circulation Drug product manufacturers Medical institutions

Main difficulties of pharmacovigilance system implementation by subjects of pharmaceutical market circulation Pharmacies Consumers Distributors

The main barriers to organize a pharmacovigilance system MAH Medical institutions

The main barriers to organize a pharmacovigilance system Pharmacies Consumers

The main barriers to organize a pharmacovigilance system

Pharmacovigilance System Improvement Improving regulatory legal acts, methodological recommendations 1 Increased activity of participation of drug market circulation entities 2 Improving of information channels 3

Mobile App «Lekarstvennaya Bditelnost» 1. Rapid collection of information about adverse reactions, lack of effectiveness 2. Targeted notifications on security issues (doctors, pharmacies, consumers) 3. Management of drug safety observational programs 4. Pharmacovigilance training for doctors, pharmaceutical workers

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