Guidelines for Drug Registration, Pre-clinical & Clinical Trials (PCT & CT), GMP certification: Procedure, Terms, State Duty
Russian GMP Certification
The Ministry of Industry and Trade Russia (Minpromtorg) is responsible for GMP certification. Russian GMP Certification consist of the following stages:
- Translation and notarization of administrative & technical documents.
- Receiving permission on the inspection of manufacturing sites
- Confirming the dates of the manufacturing site inspection
- Official Site Inspection
- Receiving the Ministry of Industry and Trade Decision
- Receiving Russian GMP certficate
Drug Registration in Russia
The Ministry of Health of Russia overlooks Pre-clinical & Clinical Trials. PCT & CT consist of the following stages:
- Translation and notarization of administrative & technical documents
- Pre-clinical trials import license obtaining
- Clinical trials permission obtaining*
- GMP certification initiation
- Confirming the dates of the manufacturing site inspection
- Site inspection
- Conduct of Clinical Trials
- Preparation and Submission of the Common Technical Document to the MoH (along with CT report)
- Official Quality Control as well as Risk&Benefit Evaluation
- Receiving the GMP certificate
- Receiving Registration Certificate
Terms: from 14 months
State duty: 2000$(CT Permission) + 5000$(Official Quality Control + 30000$ (GMP Certification)
*If local Clinical Trials are necessary
Regulatory activity
Regulatory activity consists of the following stages:
- Translation and notarization of administrative & technical
- Preliminary Quality Control*
- Compilation and Submission of the Common Technical Document to the MoH.
- Passing Official Quality Control as well as Risk&Benefit Evaluation
- MoH approval.
- Receiving Registration certificate
- Registering prices for live saving drug included in the Essential Drug List **
Terms: from 6 months
State duty: 2000$ US
Documents: (click link get the list)
*Voluntary
**If the drug is included in the Essential Drug List
Pre-clinical & Clinical Trials
Regulatory activity consists of the following stages:
- Study Design Approval indicating volume of pre-clinical as well as clinical trials.
- Pre-clinical trials conduct
- Site Selection. Documents preparation to obtain clinical trials permission from the MoH
- Receiving Clinical Trials Permission
- Receiving Samples import license to conduct Clinical Trials
- Clinical Trials Conduct and final report preparation
- Inclusion of CT report in the CTD
Terms: from 6 months
State duty: 2000$ US
Documents: (click link get the list)