SID & GP MINPROMTORG OF RUSSIA Corporate Communication Center

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Presentation transcript:

SID & GP MINPROMTORG OF RUSSIA Corporate Communication Center IV ALL-RUSSIA GMP CONFERENCE REGULATION OF THE DRUGS CIRCULATION IN EAEU: WHAT IS DONE AND WHAT IS UP TO DO D.A. Rozhdestvenskiy, Candidate of Medical Science Department of Technical Regulation and Accreditation Eurasian Economic Commission

PROGRESS OF WORK ON REGISTRATION AND EXPERT EVALUATION OF DRUGS PROCEDURE ARMENIA BELARUS KAZAKHSTAN KYRGYZSTAN RUSSIA REGISTRATION (completed) 2 (0) 5 (1+1) 36 (3+0) 49 (0+18) INSPECTIONS 1 40 (10+0) Note: the numbers in parentheses indicate "(positive + negative)" results data as of September 5, 2019 General partner: Strategic partners: Official partners: Regional partners:

DRAFT AMENDMENTS TO DECISION No DRAFT AMENDMENTS TO DECISION No. 93 ON THE RECOGNITION OF GMP INSPECTIONS DP type until December 31, 2020 until December 31, 2025 Domestic GMP-MS= GMP-EAEU Foreign REGISTRATION + REREGISTRATION REREGISTRATION Draft amendments to Decision of the ECE Council No. 93 dated 3.11.19 – current version of the document – "Liberal" revision of the project – "Conservative" revision of the project – final revision of the project

ADVICE ON PREPARING THE DOSSIER COUNCIL OF EXPERTS ON DP AUTHORIZED BODIES (EXPERT ORGANIZATIONS) Grounds Clause 5 RS 75 / 03.11.2016 Clause 26 RS 78 / 03.11.2016 The author of the appeal Authorized (expert) body of a Member State Drug registration applicant Consulting area Selection of the reference drug in the 3-4 level of the EAEU algorithm Disagreements in the positions of the AB regarding the assessment of B/R balance of drugs in circulation Analytical testing and presentation of materials for them Pre-clinical/Clinical trials Registration aspects (qualification of the application, volume of documents and data submitted) Identification of affiliates Nature Public (decisions are posted in the registry) Non-public (issued personally to the applicant) Time to completion 60 days As determined by the member state

THANK YOU FOR YOUR ATTENTION! e-mail: rozhdestvenskiy@eecommission.org phone: +7 (495) 669-2400 (ext. 3141)