Registration of drugs
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Registration of drugs

All the drugs to be launched onto the Russian pharmaceutical market must be registered according to the procedure of state registration.

RDG services:

  • Preparation of proposal for the registration of the drug (calculations on the duration, cost of the procedure, the necessity for studies)
  • Representation in the course of paperwork (without transfer of rights to possession and the use of    registration, etc.)
  • Conduct of preclinical study
  • Collection and preparation of the registration dossier
  • Preparation of normative documentation
  • Submission and maintenance of the registration dossier
  • Testing of analytical methods in the laboratory
  • Organization and conduct of pre-registration clinical study or bioequivalence study
  • Organization of logistic services for the import of drugs for studies and expertise
  • Translation of documentation

Document confirming the registration of medicinal product is the Marketing authorization issued by the Ministry of Health and Social Development.

Marketing authorization entitles its owner to import, circulation of the drug on the Russian market and its distribution. Validity of Marketing authorization in the case of newly registered in the Russian Federation medicines is 5 years; later after passing validation procedure of State Registration, Marketing authorization of unlimited duration shall be issued.

The following categories of drugs are subject to state registration:

  • original drugs;
  • generic drugs;
  • new combinations of previously registered drugs;
  • drugs that were registered earlier but are now produced in other dosage forms, in new dosage.

The following are not subject to state registration:

  • the drugs made by pharmaceutical organizations, individual entrepreneurs who have a license for pharmaceutical activity according to the drug prescriptions and requirements of medical organizations, veterinary organizations;
  • medicinal herbal raw materials;
  • drugs purchased by individuals outside the territory of the Russian Federation and intended for personal use;
  • drugs intended for export;
  • radiopharmaceutical drugs made directly by health care organizations.

State registration is not allowed for:

  • different drugs under the same brand name;
  • one drug manufactured by the same manufacturer under different trade names.

For registration of generic medicines it is necessary to have the results of clinical trial or bioequivalence study conducted in Russia, as well as the results of preclinical studies in Russia or in the country of original manufacturer.

It is possible to register without the results of clinical studies the drugs analogs of which have been registered more than 20 years ago and for which it is not possible to conduct a bioequivalence study(infusions, herbal preparations, etc.),.

The duration of drug registration takes an average of 1.5 years (depending on the duration of pre-registration studies).

Stages of drug registration:

  • Submission of registration dossier to the Ministry of Health
  • Examination of documents for the bioequivalence study or clinical trial in expert     organization
  • Conduct of bioequivalence study or clinical trial
  • Examination of the results of studies and pharmaceutical expertise in expert organization
  • Analysis of examination results in the Ministry of Health
  • Issue of Marketing authorization by the Ministry of Health

Registration dossier comprises:

  • Administrative documents
  • Data on active pharmaceutical ingredients used to manufacture the drug
  • Description of pharmaceutical properties of finished medicinal product
  • Data on the manufacturing process of the drug
  • Data on quality control of the drug
  • Information on the results of preclinical pharmacological and toxicity studies of the drug
  • Information on the results of clinical studies of the drug

The cost of registration of drugs includes the following costs:

  • State tax
  • RDG services on registration
  • Costs of conduct of preclinical studies
  • Costs for comparative product
  • Costs of bioequivalence studies or clinical trial
  • Import of drug
  • Translation of documentation