DRW Monthly
November 2009
Issue No. 35
Navigating Pharmaceutical Product Registration in the Russian Federation
The Russian Federation government has issued many regulations over the past decade to improve its drug registration system and to introduce drug safety measures to protect the public health. Despite its efforts, however, the registration system remains relatively cumbersome and lacking in transparency. Importers must navigate numerous bureaucratic layers and follow complicated procedures as well contend with significant cultural and language barriers as they attempt to register their pharmaceutical products. Consequently, importers are strongly encouraged to collaborate with either a company that is already incorporated in Russia and belongs to a US parent company, a Russian distributor/authorized agent, or a consulting company to ensure success with this process.
Registration Process
Although importers are advised to partner with in-country experts, it is still essential for them to understand the underlying governmental operations and regulations in order to monitor the progress of their own registration process. As mentioned earlier, the underlying bureaucratic structure within the Russian Federation is in itself rather complex. To begin with, authority over healthcare issues is shared between the Ministry of Health and Social Development and the Federal Supervision Service for Public Health and Social Affairs (Federal Health Service). The Ministry of Health defines state policy and issues administrative healthcare regulations relating to the production, quality and distribution of pharmaceuticals. It is the state authority, the Federal Health Service, however, that actually performs the control and supervisory functions of this process. In accordance with the Federal Law on Pharmaceuticals No. 86-FZ of June 22, 1998, which later became known as the Pharmaceutical Law, as amended on December 18, 2006, the Federal Health Service has primary responsibility for the administrative aspects of medicinal product registration as well as for coordinating the activities of specialized departments and committees within the department.(1)
Consequently, the Federal State Institution "Scientific Center for Expertise of the Remedies for Medical Use" (FGU "NCESMP"), a specialized component within the Federal Health Service, performs the actual review of the Registration Application Dossier to evaluate the medicinal products. The FGU "NCESMP" responsibilities include:
- examining each application dossier to verify its compliance with current legislative requirements;
- preparing contracts and finance/payment documents;
- coordinating the pre-registration process; and
- maintaining databases on the submitted approved documentation, variations and registered products.(2)
Within the FGU "NCESMP", two institutes exist to conduct expert assessments on various aspects of the application dossier. The Institute for Preclinical and Clinical Expertise of Drugs, which reviews the toxico-pharmacological and clinical documentation on medicinal products, and the Institute for Standardization of Drugs, which assesses the chemical-pharmaceutical documentation, specifications and routine methods of quality control of the finished medicinal products. Based on the Institutes' recommendations, the Federal Health Service issues a Registration Certificate with unlimited validity in the manufacturer's name along with a certified Patient Insert and Specifications with methods of control of the finished product.(3)
Registration Documentation Requirements
The four categories of medicinal products subject to Russian state regulation include:
- new pharmaceuticals;
- new combinations of previously registered pharmaceuticals;
- pharmaceuticals previously registered but produced in other medical forms (e.g., new doses or with other compositions of supplementary substances); and
- generic pharmaceutical products.
The state registration process currently involves several stages of review from expert assessment, pre-clinical and clinical studies to confirmation of regulatory documentation. An additional complicating factor in the process stems from frequent amendments to existing regulatory requirements which have resulted in repeated document changes.
The process, which can take a year or more to complete, and begins with the importer signing a contract and submitting several required documents to the FGU "NCESMP." The following documents must be filed with the Federal Health Service to complete the registration process:
- an application for state registration of a pharmaceutical;
- document(s) evidencing payment of state registration fee;
- generic pharmaceutical products
- the legal address of the pharmaceutical manufacturer;
- the name of the pharmaceutical, including international non-proprietary name, the scientific name in Latin and main chemical synonyms;
- the original or trade name of the pharmaceutical if it is registered as a trademark according to the Russian legislation on trademarks;
- a list of ingredients, specifying their quantity;
- instructions for use of the pharmaceutical that are in compliance with the requirements of the Pharmaceutical Law requirements;
- a quality certificate for the pharmaceutical;
- manufacturing data pertaining to the pharmaceutical and pharmacopoeia;
- a description of the methods used for quality control in the production of the pharmaceutical;
- all results of preclinical studies;
- results of pharmacological and toxicological tests conducted on the pharmaceutical;
- results of the relevant clinical trials;
- samples of the pharmaceutical for examination of its quality;
- proposals for pricing; and
- documents confirming registration of the pharmaceutical if it was registered outside Russia.
All of the above listed documents must be filed in the Russian language or be supplied with a certified Russian translation.(4)
Certification Requirement
In addition to the registration procedures mandated for importers, a Certificate of Medical Registration must be obtained. The Federal Service for Supervision in the Area of Health Protection and Social Development issues this Certificate which is valid for either 5 or 10 years.
The Certificate product registration process consists of submitting documents that display product characteristics and product/manufacturing conditions in order to demonstrate conformity with various sanitary requirements.(5)
Future Outlook
The Ministry of Health seeks increased regulation of medicinal products which has resulted in a steady stream of new and amended legislation. Although some laws have passed to make it easier for importers to register their pharmaceutical products, significant barriers still exist in the process. While the Ministry has made an effort to increase transparency and support the registration of foreign medicinal products through its launch of a website dedicated to regulatory issues, the website is still only available in Russian. It seems that as long as Russia maintains a separate and independent regulatory system, the registration of foreign medicinal products will be hampered. The sooner the Russian government aligns itself with US and EU regulatory practices, the stronger and more efficient the process will be.
Related Resources
Certificate of Product Registration
"Chapter 12: Russian Federation." Global Pharmacovigilance Laws & Regulations: The Essential Reference, Food & Drug Law Institute, 06.12.2009
Drug Regulatory Requirements in Russia
Practical Guide on Registering and Certifying Pharmaceuticals in Russia
US Foreign & Commercial Service. STAT-USA Database.
Russia. Format and Content of Applications.
Tarius Expert Summary. October 2009.
Russia. Products Requiring Marketing Authorizations.
Tarius Expert Summary. October 2009.
Russian Federation. Changes in Pharmaceutical Licensing.
(1) "Chapter 12: Russian Federation." Global Pharmacovigilance Laws & Regulations: The Essential Reference, Food & Drug Law Institute, 06.12.2009, p.205
(2) Russia. Format and Content of Applications.Tarius Expert Summary. October 2009.
(3) Ibid.
(4) "Chapter 12: Russian Federation." Global Pharmacovigilance Laws & Regulations: The Essential Reference, Food & Drug Law Institute, 06.12.2009, pp.206-207
(5) Certificate of Product Registration
If you desire further information about this topic or any other regulatory issue, please feel free to contact me:
Diane R. Whitworth
DRW Research & Information Services, LLC
(tel.) 301.916.9669
drwresearch@comcast.net
To be removed from this newsletter mailing list, please send an email to drwresearch@comcast.net and type "remove" in the subject line.
|
