Granconsult

Drug Registration

It is no secret that any new drug entering the pharmaceutical market must undergo registration and certification. Drug registration includes a state expert review that confirms the drug’s quality, safety and, of course, efficacy. Only after registration and certification can a medicine be approved for sale.

The registration procedure consists of two traditional stages:

— the process of obtaining authorization to conduct clinical studies;

— expert review of the drug’s safety and quality standards.

Our services:

  • Preparation of a drug-registration proposal (estimates of duration, cost, study needs)
  • Representation during documentation preparation (without transfer of ownership or use rights to the registration, etc.)
  • Conducting preclinical studies
  • Compiling and preparing the registration dossier
  • Preparing the regulatory document
  • Submitting and shepherding the registration dossier
  • Validation of analytical methods in the laboratory
  • Organizing and conducting a pre-registration clinical study or a bioequivalence study
  • Logistics for the import of drugs for studies and expert review
  • Translation of documentation

The document confirming drug registration is the registration certificate issued by the Russian Ministry of Health and Social Development. The registration certificate is the basis for importing, circulating and selling the drug in the Russian Federation. For drugs registered for the first time in Russia the registration certificate is valid for 5 years; thereafter, following the state re-registration confirmation procedure, an open-ended registration certificate is issued.

State drug registration applies to the following categories:

  • original medicinal products;
  • reproduced (generic) medicinal products;
  • new combinations of previously registered drugs;
  • previously registered drugs produced in other dosage forms or in new dosages.

State drug registration does NOT apply to:

  • drugs prepared by pharmacy organizations or individual entrepreneurs holding a pharmacy licence, based on prescriptions or requests from medical or veterinary organizations;
  • medicinal plant raw materials;
  • drugs purchased abroad by individuals for personal use;
  • drugs intended for export;
  • radiopharmaceuticals prepared directly in medical organizations.

State registration is NOT allowed for:

  • different drugs under the same trade name;
  • the same drug produced by the same manufacturer under different trade names.

For the registration of generic drugs, results of a clinical study or a bioequivalence study conducted in Russia are mandatory, as well as preclinical studies performed either in Russia or in the manufacturer’s country.

Drugs with analogues registered more than 20 years ago and for which a bioequivalence study cannot be performed (infusion solutions, herbal products, etc.) may be registered without clinical-study results.

Drug registration stages:

  • Submission of the registration dossier to the Ministry of Health
  • Expert review at the expert organization of the documents for the bioequivalence or clinical study
  • Conducting the bioequivalence or clinical study
  • Expert review of the study results and pharmaceutical review at the expert organization
  • Analysis of the expert-review results at the Ministry of Health
  • Issuance of the registration certificate by the Ministry of Health

The registration dossier contains:

  • Administrative documents
  • Data on the active pharmaceutical substances used to manufacture the drug
  • Description of the pharmaceutical properties of the finished drug
  • Manufacturing data
  • Quality-control data for the drug
  • Results of the drug’s preclinical pharmacological and toxicological studies
  • Results of the drug’s clinical studies

The cost of drug registration includes:

  • State fee
  • Granconsult’s registration services
  • Costs of preclinical studies
  • Costs of the bioequivalence study
  • Import of drugs
  • Translation of documentation

Our company provides drug registration services at the highest level and within the shortest possible timeframe. Note that registering an original drug takes 210 working days, and a generic — about 60. Additional time is needed for clinical studies. In such cases it is better to use qualified specialists. Our staff will optimize the registration and certification timeline as much as possible and reduce your costs.

The main stages of drug registration are:

— reviewing documents and studying them in detail;

— consulting with the executive authorities;

— pre-registration document preparation;

— pharmaceutical expert review;

— clinical study;

— obtaining the registration certificate.

Our company guarantees its clients high-quality support for a new drug’s market-entry project and its promotion. Granconsult specialists perform the full scope of drug registration and certification services — from preparing the necessary documentation to obtaining the registration certificate.