KPMG Pharma Bulletin Issue #3, 2017 (March)
KPMG Pharma Bulletin Issue #3, 2017 (March)
According to the Ministry of Healthсare’s official statement, the pharmaceuticals which were approved as Essential Drugs in 2016 but not yet included into the ED List, require filing new applications.
In the end of 2016, the Ministry’s Commission recommended 24 new positions for inclusion into the EDL, however, the Government’s Decree # 2885-p dd. 28.12.2016 had approved the List without any changes. At the same time, on November 15, 2016 the Commission ruled that the results of its work must be implemented in the following year.
As per the Ministry of Healthcare, manufacturers of the subject pharmaceuticals should have submitted new applications for inclusion into the EDL, with references to the pre-approval of the Commission in 2016 and the Commission’s Protocol Commission dated 15.11.2016.
The annual reconsideration of the EDL starts in April
The list of state control measures requiring the risk-based approach was amended. The corresponding Decree of the Government of the Russian Federation #245 dd. 02.03.2017 was signed by the Prime Minister.
The list is supplemented with 33 types of state control, including certain types of regional state control (supervision) and licensing control.
The Government’s Resolution # 806 dd. 17.08.2016 approved the risk categories and hazard classes (categories) for the activities of legal entities and individual entrepreneurs and the production assets used by them, ranked by the severity of potential negative impact resulting from non-compliance with the mandatory industry regulations, severity of the harm caused, possible frequency and extent of the potential negative impact as well as the complexity of its mitigation.
|Risk category||Hazard class||Aspects of control measures|
|Extremely high risk||1 class||A regular inspection to be carried out once during the period envisaged by the corresponding statute on state control
|High risk||2 class|
|Significant risk||3 class|
|Medium risk||4 class||A regular inspection to be carried out not more than once during the period envisaged by the corresponding statute on state control
|Moderate risk||5 class|
|Low risk||6 class||No regular inspections to be carried out
The Russian Ministry of Justice registered the Order of the Ministry of Healthcare #998н dd. 26.12.2016, which approved Roszdravnadzor’s Administrative Regulation for Supervision in Healthcare on Execution of the State Function of Federal State Supervision of Pharmaceuticals Circulation.
The Order specifies the list, sequence and terms of administrative procedures (actions); the order of their execution, including in the electronic form; the rights and obligations of the officials exercising the state supervision; the rights and obligations of entities subject to state supervision; the procedure for pre-trial (non-judicial) appeal against actions (inaction) made and decisions taken in course of the state control function execution.
The Order also sets the maximum duration of the compliance inspection at twenty business days.
On March 20, 2017 the Ministry of Justice registered the Order of Roszdravnadzor dd. 15.02.2017 #1071 "On Approval of the Procedure for Pharmacovigilance".
The Order extends the requirements for the urgent reporting to Roszdravnadzor on adverse reactions and the periodic reporting on pharmaceuticals’ safety.
It also sets out requirements for approval of risk management plans submitted by registration certificates holders to Roszdravnadzor, in case of identifying issues with safety of the drugs
The document also regulates Roszdravnadzor’s activities on analysis of the incoming data on pharmaceuticals safety and preparation of recommendations to the Ministry of Healthcare on restricting the pharmaceuticals circulation in the cases where the risk of administration outweighs possible benefits.
The Ministry for Industry and Trade has developed amendments to the Government’s Resolution #1503 dd. 30.12.2015 "On Approval of the Rules for Granting Subsidies from the Federal Budget to Russian Companies for Partial Compensation of Expenses for Developing Analogues of Innovative Pharmaceuticals with Similar Therapeutic Action and Improved Charactericstics".
The document expands the eligibility for subsidies, by means of including projects on (pre)clinical trials of pharmaceuticals, provided that the state registers of drugs contains a registered pharmaceutical with the same international non-proprietary name (or, in absence of the INN – the appropriate chemical or grouping name), same pharmaceutical form and indications for use.
On March, 10 the Russian Ministry of Justice registered the Order of the Ministry of Healthcare #11n dd. 19.01.2017 "On Approval of Requirements to the Content of Technical and Operational Documentation of Medical Devices Manufacturers".
The Requirements, which are introduced for the first time, define the list of information to be included into technical and operational documentation of a medical device submitted for the state registration after March 24, 2017 (the date of the Order enactment).
The data to be contained in the technical documentation of a medical device manufacturer (subject to submission as the part of the registration dossier) shall include, inter alia:
— information on the target consumers of the medical device,
— data on the medical device verification and validation, used for proving the compliance of the medical device with the applicable requirements,
— information on the trials carried out, protocols of the trials, analyses of their results and other applicable information.
Additional requirements are envisaged for the technical documentation of a medical device used for in vitro diagnostics.
The data to be contained in the operational documentation of a medical device manufacturer shall include, inter alia:
— technical parameters of the device,
— required periodicity of technical service/maintenance, including cleaning and disinfection of the medical device,
— requirements for preparing the medical device for repeated use, including cleaning, disinfection, packaging, and, where required, the method of repeated sterilizing;
— criteria of the medical device’s incapacity for use.
Similarly to the above, extended requirements are envisaged for medical devices for in vitro diagnostics.
Roszdravnadzor has developed a draft departmental Order “On Approval of the Procedure for Providing Consulting Services in Area of State Registration of Medical Devices by the Federal State Budget Institution ‘All-Russian Scientific Research and Testing Institute for Medical Equipment’ and the Federal State Budget Institution ‘Center for Monitoring and Clinical and Economic Expertise’ supervised by Roszdraznadzor”.
The consulting services may be provided in the following areas:
─ state registration of a medical device, except for the matters of expert examination of quality, efficacy and safety;
─ introducing amendments to the registration certificate for a medical device;
─ introducing amendments to the documents contained in the registration dossier for a medical device, except for the matters of expert examination of quality, efficacy and safety;
─ criteria for classifying goods as medical devices;
─ classification of medical devices in accordance with the Nomenclature classification of medical devices.
The above consultancy activities may not include preliminary expert examination of quality, efficacy and safety of medical devices.
The consulting shall be provided on a contractual basis and shall be paid for by the applicant.
The previous Pharma Bulletin issues are accessible our site.
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