ChorichPharm

Registration (marketing authorization) procedure

 

Registration of a medicinal product is the first step in launching the product in the Russian market. Registration (marketing authorization) procedure is an evaluation by a state agency of medicinal product quality and expected benefit to possible risk ratio from the use of the medicinal product for the purpose of further permission to use it in the RF.

Legal acts regulating registration procedure of medicinal products are the following:

  • Federal Law № 61-FZ On Circulation of Medicines of 12.04.2010 (came into effect on 01.09.2010).

The following categories of Medicinal Products are Subject to State Registration:

  1. all medicinal products initially launched in the Russian market;
  2. medicinal products previously registered but produced in other dosage forms in correspondence with dosage form list, if the new dosage form has proven its clinical relevance and efficiency;
  3. new combinations of previously registered medicinal products.

The following products are exempt from registration:

  1. medicinal products manufactured by pharmacy organizations, dispensaries of veterinary medicines and private entrepreneurs with a license for pharmaceutical activity on prescriptions for medicinal products and on requests from medical and veterinary organizations;
  2. medicinal products purchased by individuals outside of the Russian Federation and intended for personal use;
  3. medicinal products brought in the Russian Federation for medical assistance to particular patients in critical situations on the basis of permission issued by authorized federal regulatory agency;
  4. medicinal products brought in the Russian Federation on the basis of permission issued by authorized federal regulatory agency and intended for clinical study of medicinal products and/or evaluation of medicinal products by experts for the State registration of pharmaceuticals;
  5. pharmaceutical substances;
  6. radiopharmaceuticals manufactured directly in medical organizations in procedure specified by authorized federal regulatory agency;
  7. medicinal products manufactured for export.

State registration is not allowed for the following products:

  1. medicinal products differing from each other by qualitative composition of active substances and bearing the same trade name;
  2. a medicinal product fabricated by the manufacturer under different trade names and submitted for State registration as two or more medicinal products.

Authorized federal regulatory agency, regulating circulation of medicinal products, including issues or medicinal products registration, is Ministry for Public Health of the Russian Federation (Minzdrav of Russia in brief) (https://www.rosminzdrav.ru).

A particular Department for the State regulation of medicinal products circulation has been formed within Minzdrav of Russia to deal with the registration of new medicinal products and circulation of previously registered medicinal products.

Department for the State regulation of medicinal products circulation has several Offices: Office of clinical studies of medicinal products, Office for the issue of Marketing Authorization for medicinal products, Office for the regulation of medicinal products circulation, and Office for the registration of prices for vital and most important medicinal products.

Minzdrav of Russia takes decision on the issue of Marketing Authorization for medicinal products on the basis of the results of Expert evaluation report made by its subordinate organization, FGBU NTsESMP (Federal State Budgetary Institution “Scientific Center for Expert Evaluation of Medicinal Products“(www.regmed.ru)). FGBU NTsESMP conducts expert evaluation of suggested methods of medicinal product quality control, quality of submitted medicinal product samples and Benefit - Risk ratio from the use of medicinal product. Current legislation forbids FGBU NTsESMP to provide services of medicinal products expert evaluation directly to the applicant. Being a Federal State Budgetary Institution, FGBU NTsESMP conducts expert evaluations only for the Russian Ministry of Public Health, on request of the latter.

Applicant pays duty for the Marketing Authorization issued by the State to the current account of Minzdrav of Russia (state duty amount; details of state duty payment).

A state-run web portal is organized for the communication of Marketing Authorization applicants with Minzdrav of Russia http://grls.rosminzdrav.ru, as documents for medicinal product Marketing Authorization are submitted both in paper and electronic form. The portal contains open (accessible without password) and closed information (accessible only in user account after receiving password). Open information is National Register of Medicinal Products and National Register of Maximum Selling Prices. Both Registers are updated online by Minzdrav of Russia and contain most reliable information on registered medicinal products as they are official National registers. The website is in Russian only.

Application for Marketing Authorization may be submitted by legal entity acting in its own interests, or a legal entity authorized to act for another legal entity.

Stages and terms of obtaining Marketing Authorization for medicinal products.

Procedure of obtaining Marketing Authorization is the same for domestic and foreign products.

Process of obtaining Marketing Authorization for medicinal products consists of 2 consecutive parts: pre-registration procedures and medicinal product registration.

Each part includes several concurrently developing stages:

Part 1

 

Pre-registration procedures (conducted consecutively) (not all procedures are mandatory)

GMP Inspection of manufacturer by Russian inspectors

(is conducted if Manufacturer has not obtained such document in RF)

Clinical study of medicinal product in RF (only for products requiring study in Russia)

Putting up Registration Dossier in common technical document (CTD) format and preparation of medicinal product samples for the registration expert evaluation

(mandatory for all pharmaceuticals)

8-10 months

BS – 8-10 months

CS – 1-1.5 years

2-6 months

 

 

 

 

Part 2

 

 

 

Medicinal product registration (conducted consecutively)

 

 

 

Expert evaluation of medicinal product quality

 

Expert evaluation of expected benefit to possible risk ratio from the use of medicinal product (risk/benefit ratio)

 

 

 

160 workdays

In this manner, Part 2 of the registration procedure, medicinal product registration, may be started only when results of all Part 1 procedures are available.

At the moment of applying to the Ministry of Public Health for the state registration of a medicinal product, Registration Dossier should contain the following documents:

  • GMP compliance report confirming compliance of foreign manufacturer to good manufacturing practice (GMP Certificate)(a pre-registration procedure)
  • report on clinical study conducted in Russia (in case the medicinal product requires clinical study conducted in Russia) (categories of medicinal products which do not require Russian clinical study are given below) (a pre-registration procedure)
  • Dossier in CTD format should be put together (a pre-registration procedure)
  • samples taken from the same batch of the product should be prepared to be submitted for expert evaluation of product quality (a pre-registration procedure)

Categories of medicinal products which do not require clinical study(es) conducted in Russia for their state registration:

  1. If the pharmaceutical planned for the registration is a generic drug and its reference drug has been registered and has been used in Russia for over 20 years.
  2. If a multicentre study involving Russia has been conducted.
  3. If the preparation is a water solution of a generic drug with the same composition as that of the reference medical product, intended for parenteral (hypodermic, intramuscular, intravenous, intraocular, intracavitary, intra-articulate or intracoronary) administration.
  4. If the preparation is a solution of a generic drug with the same composition as that of the reference pharmaceutical, intended for peroral administration.
  5. If the preparation is a generic, with the same composition as that of the reference pharmaceutical, and is manufactured in the form of powder or liophilisate for the preparation of solutions.
  6. Medicinal gases
  7. If the pharmaceutical is a generic ear or eye medicine, with the same composition as that of the reference preparation, manufactured in the form of water solution.
  8. If the pharmaceutical is a generic topical formulation, with the same composition as that of the reference preparation in the form of water solution.
  9. If the pharmaceutical is a generic drug, with the same composition as that of the reference pharmaceutical, and is a water solution administered in the form of inhalations via nebulizer or as a nasal spray administered via similar devices.

Second part of the registration procedure, medicinal product registration:

Registration Dossier put in CTD format is submitted to Minzdrav of Russia.

In 10 days completeness of the Dossier is checked and a decision on submitting documents for expert evaluation is taken:

  1. Conducted only for orphan products! Expert evaluation of documents submitted for the decision if the submitted product may be used as a medicine after obtaining state registration as an orphan medicinal product;
  2. expert evaluation of suggested methods of medicinal product quality control and quality of submitted medicinal product samples using these methods (further, expert evaluation of medicinal product quality control);
  3. expert evaluation of expected benefit to possible risk ratio from the use of the medicinal product.

Expert Evaluation Report is then made on the basis of expert evaluation results which is submitted from expert body (FGBU NTsESMP) to the Russian Ministry of Public Health. If the Report is positive, Minzdrav of Russia experts list the product in the National Register of Medicinal Products and issue Marketing Authorization. If in the course of conducted expert evaluation it was impossible to confirm quality or effectiveness/safety of the products, decision of refusal to issue Marketing Authorization for the product is given.

In initial registration of medicinal product in Russia, Marketing Authorization is issued for 5 years. Upon expiry of this term, Manufacturer submits documents for Marketing Authorization confirmation; then, Marketing Authorization without time limit is issued.