01.04.2017 the Order of Federal Service for Supervision in Healthcare (hereinafter–“Roszdravnadzor”) No. 1071 dated 15.02.20171 came into force (hereinafter – “Order”). The Order provides for the Roszdavnadzor supervision over pharmacovigilance.
According to the current legislation the pharmacovigilance is defined as a kind of activity comprising monitoring efficiency and safety of medical drugs. The purpose of pharmacovigilance is to identify, evaluate and prevent adverse drug reactions2.
According to the Order, the pharmacovigilance is implemented by Roszdravnadzor via analyzing the information, provided by the parties to drug circulation as well as information collected by Roszdravnadzor through compliance state monitoring of drug circulation.
The Order provides for the two categories of information to be submitted by the parties to drug circulation: (1) periodic drug safety update reports and (2) occasional notifications (reports).
The periodic drug safety update reports are submitted by the holders of market authorization as well as by the holders of clinical trial authorization certificate. Meanwhile, the occasional reports shall be submitted to Roszdravnadzor by all parties to the drug circulation.
As a general rule, the periodic safety update reports shall be submitted within the terms established by Roszdravnadzor. However, in case such terms are not established by Roszdravnadzor, the periodic safety update reports shall be submitted in the following terms, which start to run on the day the medical drug (finished product) received its first market authorization worldwide:
Periodic safety update reports shall be submitted within 90 days of expiry of the aforementioned timelines (the reports of the holders of the clinical trial authorization certificate shall be submitted within 60 days respectively).
If on the basis of information obtained in the course of pharmacovigilance Roszdravnadzor recovers evidence of altering the correlation of expected benefit to potential risk of drug application, Roszdravnadzor might require the company to submit the extraordinary (unscheduled) safety update report. Such report shall be submitted within 60 days as of the date of relevant request receipt.
According to the Order, the periodical safety update reports shall be prepared in accordance with the Good pharmacovigilance practice of EAEU3. However, the reports of the holders of the clinical trial authorization certificate need to be prepared in accordance with the Good clinical practice of EAEU4.
The occasional reports shall be submitted within the following terms.
The holder of the market authorization files:
The holders of the clinical trial authorization certificate submit:
The parties to the drug circulation (medical organizations) submit:
The term for provision of the aforementioned information by medical organizations begins to run on the date when the person responsible for company’s pharmacovigilance learns:
Unlike periodic reports, that are prepared in accordance with the good practices, the occasional reports shall be submitted in accordance with the standard forms, prescribed by the Order.
For non-compliance with the procedure for submitting the aforementioned information the company can be held liable under art. 19.7.8 of the Administrative Offences Code of the Russian Federation in the form of a fine from RUB 30.000 to RUB 70.000.
The aforementioned periodical and occasional reports can be filed to Roszdravnadzor either via the Automated information collection system of Roszdravnadzor, by the means of email (pharm@roszdravNadzor.ru) or by submitting electronic data storage device.
All information submitted to Roszdravnadzor is analyzed by Roszdravnadzor’s expert organization - the Federal State Budgetary Institution “Center for monitoring and clinical-economical analysis” of Roszdravnadzor5.
If upon analysis of the information, submitted to Roszdravnadzor, the expert organization concludes, that the adverse drug reaction was or could have been caused by the company’s non-compliance with drug circulation legislation, in this case Roszdravnadzor will be entitled to initiate an inspection with regards to the company’s compliance with drug circulation legislation, including compliance with drug quality requirements, clinical trial requirements as well as with drug storage, transportation, import and sales requirements.
Should the analysis of the expert organization unveil any undocumented details concerning drug safety or drug efficiency, that can put impact on the risks and benefits pattern of drug application, Roszdravnadzor will notify the holder of market authorization /the holder of clinical trial authorization certificate). Within 10 days of receiving such notice the company is required to check the information, provided by the expert organization, and report to Roszdravnadzor respective outcome.
Within 10 business days upon receipt of the company’s report Roszdravnadzor notifies the Ministry of Health of the Russian Federation of discovering new drug data and submits all necessary information, so that the Ministry of Health can decide on the necessity of amending the drug’s registration dossier, cancel drug’s state registration, require pre-clinical, clinical or additional trial of the drug, suspend drug’s circulation until the relevant amendments to registration dossier are made or until the relevant trials have been carried out.
Furthermore, within 30 business days as of the date of receiving by Roszdravnadzor of the company’s report, the agency can require the holder of the market authorization to develop a Risk management plan. The development of the Risk management plan is provided for inpara. 6.2.3. of the Good pharmacovigilance practice of the EAEU. The Risk management plan is one of the key post-registration pharmacovigilance documents, the main purpose of which is pre- and post-registration management of drug’s “risk-benefit” ratio. The Risk management plan shall be developed in accordance with the Good pharmacovigilance practice of the EAEU and outline, inter alia, the drug’s safety profile and provide for the measures, that are taken by the holder of market authorization in order to ensure drug’s safety. The Risk management plan shall be submitted to Roszdravnadzor within 60 days upon receipt by the company of a relevant request. The Risk management plan shall specify in detail, which pharmacovigilance measures will be taken by the company in order to identify, evaluate, minimize or prevent the risks associated with the drug use including efficiency of such measures. The Risk Management plan should also provide, whether such pharmacovigilance measures are efficient enough to duly comply with pharmacovigilance requirements. Upon receipt by Roszdravnadzor of the Risk management plan, the agency will forward the plan to the expert organization. The expert organization will examine the Risk management plan and check, whether the measures proposed by the plan are considered sufficient to prevent potential harm, that could be caused by drug application. Depending on the outcome of the examination conducted by the expert organization, Roszdravnadzor can either notify the holder of market authorization of approving the Risk management plan or require to make certain amendments to the plan.
According to the explanatory note to the Order6, the purpose of the regulation is to establish a legal framework for monitoring drug security at the current level of scientific development, facilitate early discovery of potential health risks caused by the drug application and to protect people from using potentially harmful medical drugs.
1Order of Federal Service for Supervision in Healthcare No. 1071 dated 15.02.2017 “Concerning approval of the Regulation on pharmacovigilance”
2See clause 52.1 Art. 4 of the Federal law No. 61-FZ dated 12.04.2010 “On drug circulation”
3Resolution No. 87 dated 03.11.2016 “Concerning adoption of the Good pharmacovigilance practice of EAEU”
4Resolution No. 79 dated 03.11.2016 “Concerning adoption of the Good clinical practice of EAEU”
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