• Regulatory NewsRegulatory News

    USP Signs Agreement With Russian Drug Regulator to Continue Developing Quality Standards

    USP CSO Jaap Venema (right) signs agreement with Russian FDA Roszdravnadzor. The US Pharmacopeial Convention (USP) and Russia's medical products regulator forged a three-year memorandum of understanding (MOU) earlier this week that will focus on harmonizing major pharmacopeial requirements and promoting the use of modern laboratory standards, among other things. The agreement, which is an extension of an existing MOU instituted in 2009, means USP and the Federal...
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    New Medical Device Classifier Complicating Russian Registrations

    Content provided by Emergo , a medical device regulatory affairs and quality assurance consulting firm with offices worldwide. A new medical device nomenclature system launched and enforced by Russian regulators is causing challenges for registrants due to incomplete and missing codes, as well as more stringent requirements for grouping products together in the same registration. Roszdravnadzor’s  Nomenclature Classification of Medical Devices by Type  (link in R...
  • Regulatory NewsRegulatory News

    Russian Regulators Publish New Medical Device Nomenclature System

    Content provided by Emergo , a medical device regulatory affairs and quality assurance consulting firm with offices worldwide. Roszdravnadzor, Russia’s medical device market regulator, has published a new system for nomenclature classification according to 19 different device types. The  categories  (link in Russian) appear to be based on Global Medical Device Nomenclature (GMDN), which could suggest that Roszdravnadzor will realign its market registration requir...
  • Russia Developing New Guidance for IVDs

    Russia's Federal Service on Healthcare Surveillance (Roszdravnadzor) has launched a public consultation to develop new guidelines for the evaluation of the quality, effectiveness and safety of in-vitro diagnostics products.  According to the agency, the guidance will be prepared under the direction of the Ministry of Health's Head Specialist for Clinical Laboratory Diagnostics, Anatolia Kochetova, with the assistance of expert organizations and leading experts in...
  • Russian Device Reauthorization Deadline Extended

    • 17 July 2013
    Russian regulatory authority Roszdravnadzor and Russia's Ministry of Health have decided, after consulting with Russia's medical device industry as represented by the Union of Industrialists and Entrepreneurs (RSPP) and the Chamber of Commerce, to extend a deadline for reissuance of medical device registration certificates. An amendment to Government Decision 1416 of 27 December 2012 was introduced by Deputy Minister of Health Igor Kagramanyan and was approved by the M...
  • Top Russian Regulator: We Don't Have Authority to Stop Counterfeiters

    • 26 July 2012
    Russia's top regulator is claiming Russian regulators are handicapped in the fight against counterfeiting because no penalties exist under Russian law to prohibit the sale and production of counterfeit drugs. In an television interview, the Acting Head of Roszdravnadzor, Elena Telnov, said her agency is powerless to stop counterfeiters, and provided an exemple of a fake cancer drug in the Rostov region of Russia where counterfeiters were located but could not b...
  • Russia: New Clinical Trial Regulations In Effect

    New regulations governing the conduct of preclinical studies and clinical trials of drugs for medical use have entered into force in Russia, which require the Federal Service on Surveillance in Healthcare and Social Development (Roszdravnadzor) to implement control measures and the analysis of study and trial results.  The regulations also establish appeal procedures for Roszdravnadzor decisions. The changes stem from an order of the  Ministry of Health issue...