Roszdravnadzor has approved Administrative Regulation on pre-clinical and clinical trials conduct monitoring

Pepeliaev Group advises that the Ministry of Healthcare and Social Development of RF issued Order No. 1091n dated 09/29/2011 “On adoption of Federal Service for Surveillance in Healthcare and Social Development (Roszdravnadzor) Administrative Regulation regarding the performance of state controlling function over medicines pre-clinical trials and medications for medical usage clinical trials”( hereinafter the “Regulation”), which came into effect on the 1st of April, 2012.

This Regulation is designed to establish a uniform approach to the implementation of the control executed by Roszdravnadzor (control measures) over the activities of legal entities, engaged in organization and conducting of preclinical and clinical studies (medicines developers, educational institutions, scientific research organizations, contract research organizations, medical organizations) (hereinafter  “Auditees”).

State Control Subject

Compliance of Auditees activities in the field of organization and conducting of preclinical and clinical studies to legislation requirements, GCP and GLP, regulatory norms on conducting trials on animals, etc.

Methods of monitoring

Scheduled and unplanned audits. Roszdravnadzor shall collect and analyze the data, received fr om local Roszdravnadzor department, performing the audits mentioned above.
Audit notifications

Roszdravnadzor has approved a list of sources wh ere the information about state audits and notifications procedure shall be posted. In particular, the annual plan of scheduled audits and audit results shall be posted on official Roszdravnadzor and its local departments' websites within five business days since approval of an audit plan or an audit report being signed, respectively.

Roszdravnadzor or its local departments shall notify an Auditee about a scheduled audit at least three business days prior to the upcoming scheduled audit.

An Auditee shall be notified about unscheduled field audit at least twenty-four hours before the audit begins (except when the unscheduled audit is performed based on received information about violation or threat to citizen’s health or lives).

In case the unscheduled audit is to be performed based on received information about violation or threat to citizen’s health or lives, Roszdravnadzor is exempt from obligation to inform the Auditee on unscheduled audit. .

Audit Timing

Any single audit shall not take more than 20 business days, unless the Regulation specifically provides otherwise. In case complex and/or lengthy tests, examinations etc. have to be performed, the audit period may be duly extended for not more than another  20 business days.

The audit period of a legal entity, having separate divisions in different regions of the Russian Federation, shall be identified individually per each separate division but the aggregate audit period shall not exceed 60 business days.

Audit Methods and Audit Process

Scheduled and unscheduled audits shall be performed as documentary or field audits.

Scheduled audit periodicity shall not exceed one audit per every three years. An unscheduled audit shall be performed based on applications and claims received from third parties, governmental or municipal authorities and mass media informing about violation or threat to citizen’s health or lives. Anonymous applications and claims shall not to be considered.

The Auditee shall respond to justified requests of the audit authority within 10 business days since the date of the request receipt.

An appropriate Audit Report shall be issued per results of each audit. Shall any violations be identified; an Order to eliminate them shall be issued.

Rights and responsibilities

The Regulation identified the rights and responsibilities of the Roszdravnadzor and its local departments’ officers as well as the rights and responsibilities of Auditees. Please note that Roszdravnadzor is not entitled to request information or documents that are outside the scope of the audit and/or may be obtained from other governmental controlling authorities including by exchanging information electronically.

Pre-trial Appeal Procedure

The Regulation establishes the pre-trial procedure for appealing the officers’ decisions and acts/failure to act based on the audit results. The Regulation also establishes the grounds for the appeal and appeal review and consideration procedure. The term for per-trial appeal review and consideration shall be 30 calendar days from the day the appeal’s receipt  is registered by Roszdravnadzor.

The Pre-Trial Appeal Procedure is not mandatory.

To address the invocations introduced our recommendations are:

1. to regularly monitor information on scheduled audits displayed by Roszdravnadzor/its local departments  official websites or the Prosecutor Office official websites;

2. to establish an interaction procedure for various departments of your  organization (Auditee)  in order to coordinate collection and presentation of information during an audit;

3. to determine the scope of information that your organization (Auditee) will provide in response to justified requests of authorities.

Consultants’ Support

Pepeliaev Group will be pleased to advise you on any issues that you may have in relation to the Regulation; to hold training sessions preparing your staff for an audit; to provide support during an audit; and to help you develop internal policies establishing the interaction among various departments during the audits.

For further details, please contact:

in Moscow – Vladimir Sokov, Partner, at (495) 967-00-07 or by v.sokov@pgplaw.ru;  Elena Lvova, Pharmaceuticals & Healthcare Group Coordinator, at (495) 967-00-07 or by e.lvova@pgplaw.ru; Irina Naumenko, Senior Associate, at (495) 967-00-07 or by i.naumenko@pgplaw.ru