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俄罗斯药品注册,EAEU药品注册新规

  The authorized federal executive body regulating drug registration is the Ministry of Health of the Russian Federation. The Department of State Regulation of the Circulation of Medicines of the Ministry of Health of the Russian Federation deals with the issues of registration of new and circulation of already registered drugs.
The following categories of drugs are subject to state registration:
1) original drugs;
2) reproduced drugs;
3) new combinations of previously registered drugs;
4) drugs, registered earlier, but produced in other dosage forms, in a new dosage.
The data on the registered medicinal product, including the pharmaceutical substance included in the composition of the medicinal product, are included in the State Register of Medicinal Products, and the applicant is issued a Registration Certificate of the medicinal product.
In accordance with Article 28 of the Federal Law of the Russian Federation of April 12, 2010 No. 61-ФЗ “On Circulation of Medicinal Products”, a registration certificate of a medicinal product with indication of dosage forms and dosages is issued indefinitely, with the exception of a registration certificate of a medicinal product issued with a validity period five years, for the first time drugs registered in the Russian Federation ”.
Upon the expiry of the five-year term, an unlimited registration certificate of the medicinal product is issued subject to confirmation of its state registration.
The procedure for registration of drugs consists of several basic steps:
Stage I Preparation of documents for the formation of a registration dossier, including reports on the results of clinical trials of a medicinal product for medical use conducted in the territory of the Russian Federation.
Stage II. Examination of the quality of the drug and an examination of the relationship of the expected benefit to the possible risk of using the drug:
- Quality control of the drug at an authorized Laboratory Center and approval of the Regulatory Document;
- Examination of the relationship of the expected benefits to the possible risk of use and approval of the Instructions for the medical use of the drug.
Stage III. Responses to requests from the Ministry of Health of Russia on the results of the examinations.
Stage IV. The decision by the Ministry of Health of Russia to decide on the state registration of a medicinal product, the inclusion of data on a registered medicinal product, including the pharmaceutical substance included in the composition of a medicinal product, in the state register of medicinal products and the registration certificate of the medicinal product
 
RusClinic CRO provides the following services for the registration of drugs:
• consulting the customer on drug registration issues;
• preparation of a plan for registration and a list of necessary documents;
• adaptation of documentation provided by foreign partners to the requirements of the Russian Federation;
• development of regulatory documentation for drugs;
• development of instructions for the medical use of drugs;
• preparation of models of primary and secondary packaging;
• development of analysis techniques;
• development of the composition and production technology of dosage forms;
• formation of the registration dossier;
• submission of the registration dossier to the authorized federal executive body carrying out
• state registration of medicines (Ministry of Health of the Russian Federation);
• organizing and conducting research on the comparative antimicrobial activity of antibiotics;
• organization and conduct of the test of comparative dissolution kinetics;
• support of the registration process;
• obtaining permits, decisions and official requests from an authorized federal executive body that conducts state registration of medicines;
• preparation of additional materials in accordance with the requests of the authorized federal executive body carrying out state registration of medicines;
• obtaining a Registration Certificate and approved documentation (ND, instructions for medical use, packaging mock-ups) for the medicinal product.
Changes to the documents contained in the registration dossier for a registered drug
In accordance with Part 1 of Article 30 of the Federal Law of the Russian Federation of April 12, 2010 No. 61-FZ “On Circulation of Medicinal Products”, “in order to amend the documents contained in the registration dossier for a registered medicinal product for medical use, the applicant submits authorized federal executive body statement on making such changes in the form established by the authorized federal executive body, and the amendments attached thereto to the specified documents as well as documents confirming the need for such changes. ”
The document confirming the introduction of changes to the documents contained in the registration dossier for a registered drug is the decision to amend the documents contained in the registration dossier for a registered drug.
Part 2 of Article 30 of the Federal Law of the Russian Federation of April 12, 2010 No. 61-ФЗ “On Circulation of Medicinal Products” provides several options for amending the documents contained in the registration dossier for a registered drug:
1) with the examination of medicinal products in terms of quality of medicinal product;
2) with the examination of medicines in terms of examination of the relationship of the expected benefits to the possible risk of using the drug for medical use;
3) with the examination of medicinal products in terms of the quality of the medicinal product and the ratio of the expected benefit to the possible risk of using the medicinal product for medical use;
4) without an examination of drugs.
Changes requiring examination of the medicinal product:
1. in case of changes in the instructions for use of the drug in relation to the information:
a) dosage form indicating the names and quantitative composition of active ingredients and the qualitative composition of excipients (if necessary, the quantitative composition of excipients);
b) pharmacodynamics and pharmacokinetics (with the exception of the pharmacokinetics of homeopathic medicines and herbal medicines);
c) indications for use;
d) contraindications for use;
e) precautions for use;
e) an indication of the possibilities and characteristics of the use of the drug for medical use by pregnant women, women during breastfeeding, children, adults with chronic diseases;
g) dosing regimen, methods of administration and use, if necessary, the time of taking the drug, the duration of treatment, including in children, before and after one year;
h) possible side effects and adverse reactions in the use of the drug;
i) symptoms of overdose, measures to assist overdose;
j) interaction with other drugs and (or) food products;
l) the form of release of the drug;
m) an indication (if necessary) of the peculiarities of the effect of the drug at the first dose or when it is canceled;
m) information on the possible effect of a medicinal product for medical use on the ability to drive vehicles and machinery;
o) the expiration date and an indication of the prohibition of the use of the medicinal product after the expiration date;
n) storage conditions;
p) vacation conditions;
2. in case of changes in the composition of the medicinal product for medical use;
3. in the event of a change in the place of production of a medicinal product for medical use;
4. in case of a change in the quality indicators of a medicinal product for medical use and (or) methods of quality control of a medicinal product for medical use;
5. in the event of a change in the shelf life of the drug for medical use.
6. in case of making other changes to the instruction on the medical use of the medicinal product, as well as to other documents contained in the registration dossier for the registered medicinal product.
The procedure for amending the documents contained in the registration dossier for a registered drug consists of several main steps:
Stage I Preparation of documents, the formation of a package of documents.
Stage II. Submission to the Department of State Regulation of the Circulation of Medicinal Products of the Ministry of Health of the Russian Federation of an application for amending the documents contained in the registration dossier for a registered drug, and a set of documents
Stage III. Getting the Decision on the direction to the expert institution assignment for the examination of the drug.
Stage IV. Examination of the drug.
Stage V Decisions to amend the documents contained in the registration dossier for a registered drug.
RusClinic CRO provides the following services for amending the documents contained in the registration dossier for a registered drug:
• Consultation of the customer regarding changes to the documents contained in the registration dossier for a registered drug;
• preparation of a plan for amending the documents contained in the registration dossier for the registered drug and a list of necessary documents;
• adaptation of documentation provided by foreign partners to the requirements of the Russian Federation;
• development of draft regulatory documentation (statement of changes to regulatory documentation) for medicinal products, taking into account the changes made;
• development of instructions for the medical use of drugs (statement of changes to the instructions for medical use), taking into account the changes made;
• preparation of models of primary and secondary packaging, taking into account the changes made;
• Formation of a package of documents for making changes to documents contained in the registration dossier for a registered drug;
• submission of a package of documents to an authorized federal executive body that carries out state registration of medicines (Ministry of Health of the Russian Federation);
• accompanying the process of making changes to the documents contained in the registration dossier for a registered drug;
• obtaining permits, decisions and official requests from an authorized federal executive body responsible for making changes to documents contained in the registration dossier for a registered drug;
• preparation of additional materials in accordance with the requests of the authorized federal executive body that makes changes to the documents contained in the registration dossier for a registered drug;
• obtaining the Decision on introducing changes to the documents contained in the registration dossier for the registered drug and the approved statements of changes to the ND, instructions for medical use, and packaging for the drug, taking into account the changes made.
Confirmation of state registration of drugs
In accordance with Article 28 of the Federal Law of the Russian Federation of April 12, 2010 No. 61-FZ “On the Circulation of Medicinal Products”, “a registration certificate of a medicinal product with indication of dosage forms and dosages is issued indefinitely, with the exception of a registration certificate of a medicinal product issued with a validity period five years, for the first time drugs registered in the Russian Federation ”.
Upon the expiry of the five-year term, an unlimited registration certificate of the medicinal product is issued subject to confirmation of its state registration.
In accordance with Article 29 of the Federal Law of the Russian Federation of April 12, 2010 No. 61-ФЗ “On Circulation of Medicines”:
- an application for confirmation of the state registration of a medicinal product is submitted to the Ministry of Health of the Russian Federation no earlier than one hundred eighty days before the expiry of the registration certificate of the medicinal product;
- confirmation of the state registration of a medicinal product is carried out according to the results of an examination of the relationship of the expected benefit to the possible risk of using the medicinal product based on the results of monitoring the effectiveness and safety of the medicinal product;
- during the procedure of confirming the state registration of a medicinal product, its circulation in the Russian Federation is not suspended.
The procedure for confirming the state registration of drugs consists of several basic steps:
Stage I Preparation of documents, the formation of the registration dossier.
Stage II. Submission to the Department of State Regulation of the Circulation of Medicinal Products of the Ministry of Health of the Russian Federation, which carries out the state registration of medicinal products, statements on the confirmation of state registration of the medicinal product, as well as a set of documents
Stage III. Getting a decision on the examination of the relationship of the expected benefits to the possible risk of using the drug.
Stage IV. Examination of medicinal products in terms of examining the relationship of the expected benefit to the possible risk of using a medicinal product and an examination of the quality of the medicinal product, in the event of changes in the regulatory documentation or regulatory document.
Stage V The decision to confirm the state registration of the drug.
CJSC "RUSKLINIK" provides the following services for the confirmation of state registration of drugs:
• consultation of the customer on the issues of confirmation of registration of drugs;
• preparation of a plan to confirm registration and a list of required documents;
• adaptation of documentation provided by foreign partners to the requirements of the Russian Federation;
• formation of a package of documents;
• development of instructions for the medical use of drugs;
• preparation of models of primary and secondary packaging;
• formation of the registration dossier;
• submission of the registration dossier to the authorized federal executive body in charge of the state registration of medicines (Ministry of Health of the Russian Federation);
• support of the registration confirmation process;
• obtaining permits, decisions and official requests from an authorized federal executive body that confirms the state registration of medicines;
• preparation of additional materials in accordance with the requests of the authorized federal executive body that confirms the state registration of medicines;
• obtaining an unlimited Drug Registration Certificate.




Representatives of the regulatory authority of Kazakhstan reported that the first applications for registration of medicines had already been submitted according to the unified rules of the EAEU, and representatives of the regulator of Belarus confirmed their readiness to accept such applications.
In 2018, the EEC plans to adopt “third-level” acts regulating the common market of medicines in the EAEU: 67 documents relating to the production, clinical studies, regulation of medicinal herbal preparations, and preparation of registration dossiers.
The rules for registration and examination of medicinal products for medical use within the EAEU, approved by the decision of the EEC Council of November 3, 2016 No. 78 (the “Rules”), entered into force on May 6, 2017.
The rules provide two procedures for the registration of drugs:
1) the mutual recognition procedure, in which the registration is carried out first in the reference state chosen by the applicant, then in the recognition states at the request of the applicant;
2) a decentralized procedure whereby registration is carried out simultaneously by several Member States that have filed an application for registration of a drug, with the choice of a reference state.
A registration certificate for a newly registered medicinal product in a reference state is issued for a period of 5 years, after which, subject to confirmation of its registration (re-registration) of a medicinal product, an indefinite registration certificate is issued.
As part of the registration dossier when submitting an application for registration, confirmation of registration (re-registration), bringing the medicinal product into compliance with the EAEU requirements, the applicant must present a valid document confirming compliance of the production site (production sites) where the finished dosage form is produced and issuing quality control of the medicinal product , declared for registration (re-registration), requirements of good production practice of the EAEU.
Before December 31, 2018, instead of such a document, the applicant is entitled to submit a document confirming compliance with the requirements of good manufacturing practice, issued to the manufacturer of the medicinal product by the authorized body of the EAEU Member State.
For the purpose of registration in accordance with the Rules, preclinical studies of drug safety are carried out in accordance with the requirements of the rules of good laboratory practice of the EAEU, clinical studies - in accordance with the requirements of the rules of good clinical practice of the EAEU.
During the examination of medicinal products, preclinical and clinical studies conducted in non-EAEU member states are reviewed on the condition that they are planned, conducted and described in the clinical or preclinical research report, respectively, according to:
- requirements of good laboratory practice, equivalent to the requirements of the EAEU (or not less) - in relation to preclinical studies;
- requirements of good clinical practice, equivalent to the requirements of the EAEU (or not lower), as well as the principles of the Helsinki Declaration of the World Medical Association "Ethical principles of medical research with human participation as an object of study" - applied to clinical studies.