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  • Medicines Agencies schedule in the CIS countries due to COVID-19 pandemic

    Medicines Agencies schedule in the CIS countries due to COVID-19 pandemic

    Please, note the changes in the schedule of some Expert Centres: Ukraine – State Expert Centre of the Ministry of Health “Single Window” stopped individual reception of people for the quarantine period.To submit the documents applicant/representative should make an appointment by e-mail to: [email protected]. The terms of the evaluation should not be affected – dec.gov.ua…

  • Basic documents in the framework of PV in the EAEU. Practical peculiarities of PSUR preparation

    Basic documents in the framework of PV in the EAEU. Practical peculiarities of PSUR preparation

    Given the evolving situation with coronavirus (COVID-19), SmartPharma Group is forced to postpone the training сourse, сonsisting of 3 webinars and training workshop devoted to the “Basic documents in the framework of in the EAEU. Practical peculiarities of PSUR preparation”. Webinar course is postponed till September, 2020. Training workshop will be held on the 8-9…

  • New Chairman of the EAEU Pharmacopoeia Committee

    New Chairman of the EAEU Pharmacopoeia Committee

    Ardak Tulegenova, a new Chairman of the EAEU Pharmacopoeia Committee who was elected on March 18, 2020, announced the release of the 1st volume of the Union Pharmacopoeia in 2020. It will consist of the general pharmacopoeial monographs for the different dosage forms that would allow preparation of specifications and quality control documents for medicines…

  • Basic documents in the framework of pharmacovigilance in the EAEU. Practical peculiarities of PSUR preparation

    Basic documents in the framework of pharmacovigilance in the EAEU. Practical peculiarities of PSUR preparation

    SmartPharma Group is delighted to invite you to participate  in a training сourse, сonsisting of 3 webinars and training workshop devoted to the “Basic documents in the framework of pharmacovigilance in the EAEU. Practical pecularities of PSUR preparation”. The training workshop will be held on the May 28-29 in Saint-Petersburg, Russia. For detailed information, please, refer…

  • National Centre for Expertise of Medicines and Medical Devices of the Republic of Kazakhstan has indefinitely suspended production and quality assurance inspections from February 27, 2020.

    National Centre for Expertise of Medicines and Medical Devices of the Republic of Kazakhstan has indefinitely suspended production and quality assurance inspections from February 27, 2020.

    The decision was made considering current situation with the spread of coronavirus in the world and will obviously impact marketing authorisation timelines. This concerns manufacturers of medicines and medical devices from China, South Korea, Iran, Singapore, Malaysia, Italy, Japan, Thailand, USA, Vietnam, Germany, Australia, UAE, the UK and France. For detailed information refer to the…

  • An audit of pharmacovigilance in health facilities will cause increased reports of adverse reactions.

    An audit of pharmacovigilance in health facilities will cause increased reports of adverse reactions.

    Roszdravnadzor sent letters  to medical organizations about the organization of pharmacovigilance work, including criteria for auditing the pharmacovigilance system. These are the first mass audits after regulatory changes in pharmacovigilance. In its letter, Roszdravnadzor identifies three main signals that are important not only for the recipients of the message, but also for the industry as…

  • In July 2020, new ICH guidelines should come into force

    In July 2020, new ICH guidelines should come into force

    The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted 2 annexes to the guidelines of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The regulator’s decision came after 2.5 years of public consultations. Thus, 2 documents are scheduled to come into…

  • Training event “Management and operation of pharmacovigilance system in EAEU

    Training event “Management and operation of pharmacovigilance system in EAEU

    Training event “Management and operation of pharmacovigilance system in EAEU. Critical aspects” was held by SmartPharma Group, on the 20-21 February 2020 in Vilnius, Lithuania. Speaker – Ivan Vorobiev, Member of International Association ISOP, participant of the development of the EAEU PV quality system. Following important topics were discussed during the event: quality system of…

  • A number of permits in the sphere of MP circulation will be available in electronic form

    A number of permits in the sphere of MP circulation will be available in electronic form

    The Government of the Russian Federation has approved the plan of transition of federal executive bodies to the implementation of priority state functions on issuing permits in electronic form. Order of the Government of the Russian Federation No. 218-r dated February 6, 2020 was published on the static.government.ru   portal. The plan provides for an accelerated transition…

  • Criteria for assigning software to medical devices

    Criteria for assigning software to medical devices

    The Commission of the Federal State Budgetary Institution “VNIIMT” of Roszdravnadzor for issuing conclusions on requests related to the circulation of medical devices considered the Criteria for Attribution of Products to Medical Devices in terms of software and concluded that the Criteria are harmonized in accordance with international classifications and contain the criteria to refer…