Russia BE Study [Regulatives / Guidelines]

posted by Brus – Spain, 2020-10-21 10:42 (41 d 20:58 ago) – Posting: # 22042
Views: 872

Dear Beholder,

Excuse me for insisting on this issue, but with the creation of the EAEU (2016 aprox) and Russia being part of it, FL 61 will be replaced by the EAEU's own laws in 2025. In fact if I'm not wrong, national NDA will no longer be able to be submitted, instead, "MRP" or "DCP" of the EAEU will have to be submitted.

The general law for medicines in the EAEU is Decision No. 78 On the Rules of marketing authorization and assessment of medicinal products for medical use. It specifies the following regarding clinical trials sites:

Within the procedure of granting a marketing authorization for a medicinal product, the
clinical study reports included in the Module 5 of the marketing authorization application dossier shall be taken into account in the assessment subject to either of the following conditions:
  • the clinical trials had been conducted in compliance with the Member States legislation
    and within their territory before 1 January 2016 (based on the date of the last visit of the last patient (volunteer)) or were being conducted as of 1 January 2016 (the recruitment of the patients (volunteers) into those studies should have been completed by this date)
  • the clinical trials had been conducted in part or fully within the countries of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for
    Human Use (ICH) before 1 January 2016 (based on the date of the last visit of the last patient
    (volunteer)) based on which the medicinal product has been authorized for marketing in the
    countries of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH)
  • clinical trials commenced after 1 January 2016 have been conducted in compliance with
    the international agreements and acts which constitute the law of the Union and at least one
    clinical study has been conducted fully or in part (as regards of data obtained from the study
    subjects) within the Union.
If the requirements referred to in the second to fourth subparagraphs of this paragraph are
not complied with, before applying for the marketing authorization for a medicinal product, the
applicant must conduct clinical trials (at least one trial at the applicant’s disposal and as agreed with the competent authority) fully or in part within the Union, or the competent authority shall trigger an unscheduled inspection of one clinical trial site where the trial has been conducted, within the assessment of the marketing authorization application dossier.


From what I understand it is now possible, in the context of EAEU and no longer FL61, to execute the entire clinical trial outside of Russia or EAEU. What is your opinion? Or is that just the theory but in practice clinical trials are executed in Russia or EAEU? Do you know what is the usual practice?

Best regards,

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