Registration of medicines is a mandatory procedure, after which it becomes possible to bring the drug to the Russian market. For its successful implementation, it is necessary to prepare several documents, as well as subject a new drug to an examination.
Unfortunately, on the Russian territory, the state registration of medicinal products remains a laborious and time-consuming process and requires significant financial investments.
Our company has a rich experience in the implementation of such procedures. We will take care of all the preparation of the necessary documentation, and we will also be able to find out how correctly the required laboratory tests are completed and executed. Our employees are experienced professionals who will provide proper legal support and conduct testing at the proper level.
In this article, we will tell you what the state registration of medicines is, we will give information about which drugs this procedure is mandatory for, and also describe in detail the stages of its implementation.
What medicines must be registered?
State registration is mandatory for the following categories of medicines:
- Original drugs;
- Products containing substances identical to the original;
- Combinations of highly effective drugs that have already been registered;
- If there is a need to change the dosage and dosage form – in relation to previously registered drugs.
Registration of medicines is not necessary in the following situations:
- If the process of manufacturing drugs by pharmacies and individuals was carried out in accordance with the requirements of medical institutions and according to a unique recipe;
- Medicines that were purchased in foreign countries and were intended for personal use;
- Vegetable raw materials.
By contacting our company, you can count on professional assistance in drug registration. In addition, we are ready to give detailed advice on all your questions. Our qualified specialists always bring their activities to the desired result, that is, until they receive a registration certificate for any drug of foreign or Russian origin. The rich experience of work enables us to effectively solve all the problems arising in the process of paperwork and registration.
Stages of drug registration?
According to the rules for registration of medicines, the process prior to obtaining a certificate is the same for both domestic products and foreign manufacturers.
So, registration of medicines includes four sequential steps:
1. Registration and transfer of the registration documents to the Ministry of Health of the Russian Federation.
The goal of compiling such a dossier is the proper conduct of the registration procedure. At the same time, all the documentation necessary for the implementation of clinical trials is prepared.
- Administrative documentation.
- Information about the active substances that are involved in the manufacturing of the medicinal product.
- Characterization of the pharmaceutical qualities of the finished raw materials.
- Information directly related to the manufacturing process of a particular drug.
- Information obtained during drug testing.
- Data (preclinical) obtained during toxicological and pharmacological control.
- Data that were obtained during clinical trials.
What requirements must be observed when preparing documentation?
When registration of medicinal products is carried out, a mandatory requirement is the execution of documentation in Russian.
In this case, the following rules are observed:
- Documents that were previously issued by authorized structures of another state must be legalized through the consulate.
- The reports and certificates issued by the manufacturer must be certified by an authorized person.
- The data obtained during clinical and before clinical trials must be reflected in the original documents or copies, after which the authorized person puts their signature and seal.
- Descriptions of the preparation process and specifications should be provided in the form of copies.
Among the innovations in the field of drug registration is the fact that clinical trials are carried out in our country on mandatory conditions. Moreover, this condition applies to all funds. Such studies are not carried out only in the situation if the registration of medicines was carried out in Russia more than twenty years ago and the possibility of studying bioequivalence is excluded. For example, for drugs such as pancreatin and metronidazole, it is not possible to test for EB.
The cost and amount of research can be influenced by the following points:
- Type of product, method of administration and dosage form. When it comes to the reproduced product and its internal use, more than 20 healthy people are tested for bioequivalence. If such a drug is supposed to be used for parenteral purposes, then the effect of the original drug is tested on more than 60-70 patients.
- What pharmacotherapeutic group does this drug belong to and in what cases it is prescribed.
- The likelihood of conducting research in other states. If the tests and registration of medicines have already been carried out in the EAEU countries, there is automatically no need to repeat them. However, even after carrying out all the necessary checks abroad, this does not affect the number of medical clients living in other regions of the Russian Federation.
- Implementation of international multicenter tests, which are partially carried out on the territory of our country. If the Russian Federation has participated in any international study, the need for additional tests is excluded.
As evidenced by the rules for registration of medicines, if preclinical trials are performed outside Russia, the applicant must submit a personal report.
As for clinical trials, a special authorization document should be obtained from the Ministry of Health of the Russian Federation for their conduct. Roszdravnadzor controls the correctness of the above measures.
During the testing period, the registration process is temporarily suspended. In general, it can take 8-18 months to complete.
3. Conducting a quality examination, as well as an examination of the ratio of the potential benefit to the potential risk that may arise in the process of using the product - carried out after completing clinical trials.
This stage will be subdivided into two sub-stages, which will be discussed below.
Approval of the Normative Document. Quality control at FGBU NTsESMP.
After the clinical trial is completed, a report with the received data is sent. In this case, the applicant must provide a document confirming the payment of the state fee, as well as submit an application for the renewal of registration activities to the Ministry of Health of the Russian Federation. After the resumption of the procedure, the dossier is sent to the FGBU NCESMP. This is necessary for the production of quality expertise, as well as checking the ratio of the potential benefit to the potential risk that may arise in the process of using a particular drug.
As part of the above step, an examination of the declared quality control methods (Normative document) is carried out, as well as an examination of the quality of the available samples. This assumes that this technique can be used in the Laboratory.
In addition, when there is a registration of medicinal products in the Russian Federation, samples of the drug must be transferred by the manufacturer to the FGBU NCESMP of the Ministry of Health of Russia. This process has a 15-day period. However, the provision of samples is made only after the issuance of an authorization document for the implementation of the examination or the renewal of registration activities. Since the period for the transfer of drug samples is minimal, they must be imported approximately 30-60 days before proceeding to the third step.
Examination of the ratio of potential benefits to potential risks that may arise during the use and approval of the Instructions.
Based on the information displayed in the registration dossier, as well as on the clinical trials performed and the results of using the product, the specialists of the FGBU NCESMP carry out an examination and make the necessary changes to the Instruction. Then they draw up a conclusion on the safety and effectiveness of the drug.
The conclusion obtained as part of the examination procedure performed is sent from the FGBU NTsESMP to the Ministry of Health of the Russian Federation. If a positive decision was made, the specialists of the Ministry of Health of the Russian Federation include the drug in the state register and issue a Registration Certificate. If during the examination process it was not possible to verify the safety or quality of the drug, then the applicant receives a document stating that the registration of drugs in the Russian Federation cannot be carried out.
When the initial registration of medicinal products in Russia is performed, the certificate is issued for a 5-year period. After the end of this period, the manufacturer provides documents confirming the fact that the registration procedure for medicines has been carried out. Further, the registration certificate is provided indefinitely.
Duration of registration of medicines in Russia
According to Law No. 61-FZ “On Circulation of Medicines”, the period for registration of medicines reaches 215 working days. This period does not include the time allotted for the implementation of clinical trials.