1. 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

2. 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:

3. 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
– current version of the document
– "Liberal" revision of the project
– "Conservative" revision of the project
– final revision of the project

4. ADVICE ON PREPARING THE DOSSIER
COUNCIL OF EXPERTS ON DP
AUTHORIZED BODIES (EXPERT ORGANIZATIONS)
Grounds
Clause 5 RS 75 /
Clause 26 RS 78 /
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

5. THANK YOU FOR YOUR ATTENTION!
phone: +7 (495) (ext. 3141)