Guidelines for Drug Registration, Pre-clinical & Clinical Trials (PCT & CT), GMP certification: Procedure, Terms, State Duty

Regulatory activity

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Regulatory activity consists of the following stages:

  1. Translation and notarization of administrative & technical documents
  2. Preliminary Quality Control*
  3. Compilation and Submission of the Common Technical Document to the MoH.
  4. Passing Official Quality Control as well as Risk&Benefit Evaluation
  1. MoH approval.
  2. Receiving Registration certificate
  3. 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

Drug Registration in Russia

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Pre-clinical & Clinical Trials

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Russian GMP Certification

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Russian GMP Certification

The Ministry of Industry and Trade Russia (Minpromtorg) is responsible for GMP certification.

Russian GMP Certification consist of the following stages:

  1. Translation and notarization of administrative & technical documents.
  2. Receiving permission on the inspection of manufacturing sites
  3. Confirming the dates of the manufacturing site inspection
  4. Official Site Inspection
  5. Receiving the Ministry of Industry and Trade Decision
  6. Receiving Russian GMP certficate

Terms: from 10 months

State duty: 30 000$ US

Documents: (click link get the list)

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Drug Registration in Russia

The Ministry of Health of Russia is responsible for drug registration and subsequent circulation. Drug registration consists of the following stages:

  1. Translation and notarization of administrative & technical documents
  2. Pre-clinical trials import license obtaining
  3. Clinical trials permission obtaining*
  4. GMP certification initiation
  5. Confirming the dates of the manufacturing site inspection
  6. Site inspection
  7. Conduct of Clinical Trials
  8. Preparation and Submission of the Common Technical Document to the MoH (along with CT report)
  9. Official Quality Control as well as Risk&Benefit Evaluation
  10. Receiving the GMP certificate
  11. 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

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Pre-clinical & Clinical Trials

Regulatory activity consists of the following stages:

  1. Study Design Approval indicating volume of pre-clinical as well as clinical trials.
  2. Pre-clinical trials conduct
  3. Site Selection. Documents preparation to obtain clinical trials permission from the MoH
  4. Receiving Clinical Trials Permission
  5. Receiving Samples import license to conduct Clinical Trials
  6. Clinical Trials Conduct and final report preparation
  7. Inclusion of CT report in the CTD

Terms: from 6 months

State duty: 2000$ US

Documents: (click link get the list)

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