Full list of documentation needed for registration of Medicines in Russia

Russian registration dossier:

Administrative part

  1. Application
  2. State duty
  3. Power of Attorney for Applicant
  4. Manufacturing License or GMP certificate. – for Russian manufacturers.
  5. Manufacturing License and GMP certificate. – for foreign manufacturers.
  6. Draft of Patient Information List (PIL)
  7. PIL or SmPC approved in country of manufacturer.
  8. Mock-ups.
  9. Draft of Normative Documentation (ND), or link to monograph of Russian Pharmacopoeia.
  10. Regaitrstion status.
  11. Confirmation of registration as orphan drug in other countries.
  12. Risk Management Plan (for BIO products).
  13. PV system.
  14. CoA’s of FDF (Finished Drug Product) for 3 batches. 

Part of Chemical, Pharmaceutical, Biological documentation

  1. Information about Active Pharmaceutical Ingredient (API)
  2. Information about Finished Drug Product (FDP)

Part of Pharmacological, Toxicological documentation

  1. PD (Pharmacodynamic) studies Report
  2. PK (Pharmakokinetic) studies Report
  3. Toxicological studies Report

Part of Clinical documentation

  1. Report about Bioavailability, Bioequivalence, in vitro\in vivo correlation.
  2. Reports about PK studies.
  3. Reports about PD studies.
  4. Reports about safety and efficacy.
  5. Reports about postregistration experience.

Additional requirements (by product type):

Products, registered more to 20 years (except BIO):

Mod 4, 5: Literature overview of Clin and Nonclin part and postregistration experience.

Gx:

Mod 4: Nonclin Literature overview of CT of referent product.

Mod 5: BE study.

Gx (water solution\parenterals\gases):

Mod 4: Nonclin Literature overview of CT of referent product.

Mod 5: Confirmation of identity of composition to referent product (except gases).

Combinations:

Mod 4: Nonclin Literature overview of CT of referent products included in combination

Mod 5: see general requirements (usually CT III Phase)

Orhan:

Mod 5:

  1. Report about Bioavailability, Bioequivalence, in vitro\in vivo correlation.
  2. Reports about PK studies.
  3. Reports about PD studies.
  4. Reports about safety and efficacy.

CT could be performed out of Russia in acc. to GCP.

BIO (Blood derived):

Admin:

  • Plasma Master File (PMF)

Mod.3

  • Selection, transportation and storage of blood (components).
  • Results of testing blood\plasma pools.
  • Packaging for donated blood\plasma.