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    Clinical trials of medicinal products in Estonia

    01.09.2014
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    Clinical trials in their modern meaning have been carried out in Estonia since early 1990s. The variety of medical specialities and the annual number of submitted clinical trial protocols have steadily increased over the last two decades but the growth has stalled in the recent few years. The government and the indusrty are constantly working to improve the clinical research environment in Estonia. The number of study centres per protocol, being 1-2 in the early years, has grown as the research has reached out from the tertiary care to the county hospitals and GP-s. Most of the trials are Phase III and II, but also a few pharmacokinetic and bioequivalence studies are carried out each year.

    The clinical trials are regulated by the Medicinal Products Act and in more detail by the regulations of the Minister of Social Affairs:
    Conditions and Procedure for Conducting Clinical Trials of Medicinal Products*
    Procedure for reporting serious adverse events occurring in clinical trials
    Rules of procedure of medical ethics committee for clinical trials, a list of data to be submitted for obtaining approval, procedure for adoption of resolutions and format of application for obtaining approval
    Information to Sponsors of Clinical Trials - Reporting requirements of SUSARs

    The regulation of clinical research is in full compliance with the respective EU legislation.
    In general terms, approval by one of the two Independent Ethics Committees and informed consent by the study subject, according to the international codes and Declaration of Helsinki, is mandatory. Clinical trial medication should be manufactured according to the GMP (Good Manufacturing Practice) and the trials should be performed and the data generated in compliance with the GCP (Good Clinical Practice) to ensure the ethical and scientific integrity of the trial (GCP code close to the Nordic document by the NLN was mandatory since 1991, later the ICH GCP was adopted and is currently directly referred to by the legislation).

    Notification of the clinical trial needs to be submitted to the State Agency using the EudraCT format. A formal letter of ‘no objection’ will be given within 30 days for phase II – IV studies (for phase I studies within 60 days and  for gene therapy or somatic cell therapy or medicinal products containing genetically modified organisms within 90 days after receipt of the application and required documentation). The time taken by the Agency depends directly on the quality and completeness of the documentation submitted. Please note that together with the notification, a signed  declaration by the head of the health-care institution (study centre) has to be submitted. After that the import certificate for the study medications can be applied for.

    An activity licence holder (according to the Medicinal Product Act  § 18) can import medicinal products intended for clinical trials after the clinical trial has been approved by the State Agency of Medicines. The State Agency of Medicines shall be duly notified of conveyance of goods from Estonia to an Member State of the European Economic Area or from an Member State of the European Economic Area to Estonia. This notification should be done as soon as possible but not later than on the fifth working day after the goods are exported or imported.
    Please send your notifications through the Client Portal.

    The import certificate is needed only for import investigational medicinal products from third countries (outside European Economic Area) to Estonia.
     

    If a medicinal product is listed as a narcotic drug or psychotropic substance in the Annex I of the Regulation No. 73 of the Minister of Social Affairs of 18 May 2005 then it shall be imported and exported under the conditions and pursuant to the procedure provided for in the Medicinal Products Act (RT I
    2005, 2, 4; 13, 63; 24, 180) and in legislation established on the basis thereof.

    The substantial amendments to the protocol and changes to the study conduct need to be submitted to the Agency in written format together with XML-file on disk (CD-ROM) for EudraCT. If written receipt confirmation is needed, this should be clearly stated and the respective form filled out (digital signature is accepted) and submitted together with the amendment.

    International standards of safety reporting apply: all suspected unexpected serious adverse reactions from any country should be reported by the sponsor in accordance with ICH E2A, the CIOMS form is preferable.
    The Agency has the right to inspect all aspects of a clinical trial as well as the performance of the Ethics Committees. The first GCP inspections were carried out in 1999, currently there is a for-cause inspection policy. Several international inspections by both the EMEA (European Medicines Agency) and the FDA (US Food and Drugs Administration) teams have been carried out in Estonia. The Agency participates in all inspections as an observer and expects to be notified of any planned foreign inspection in Estonia by the sponsor.
    Documents required with clinical trial notification:

    Coordinated assessment of multinational CTAs through the Voluntary Harmonisation Procedure (VHP)

    Ongoing clinical trials 01.09.2014

    Further information about clinical trials can be obtained from:
    Dr Ülle Toomiste
    Phone: + 372 737 4140
    E-mail: clinical.trials@ravimiamet.ee