The latest updates in the legislation on the circulation of medicines in Russia. Part 1.
Medicines and their circulation norms according to the Federal legislation of the Russian Federation
Federal Law No. 429-FZ "On Amendments to Federal Law No. 61-FZ "On the Circulation of Medicines" (hereinafter referred to as the "Law on the Treatment of Drugs") was signed by the President of the Russian Federation on December 22, 2014.
According to it, a number of important amendments were made to the Federal Law. The fundamental innovations have been in force since July 1, 2015, some provisions took force on January 1, 2016, and the final part of the innovations - on January 1, 2017. Now, we will address the important innovations in the law on the treatment of drugs.
What has changed in the law on the treatment of drugs
The most intensive new set of amendments to the law was prepared in 2013-2014 with the aim of fixing the existing shortcomings. Then a number of options, among which was law N 555485-6, later adopted by the State Duma of the Russian Federation, were considered.
According to the explanatory text to this law, the purpose of the innovations is to regulate the range of medicines available on the market, to ensure their quality and grant the required additional powers for the federal executive bodies. The necessity is due to the practical application of the law on the circulation of medicines, the growth in applicant satisfaction with the registration progress of medicines.
Updating existing concepts and formation new terminology
The innovations in the law on the circulation of medicines specify the concepts that were established earlier. Moreover, they complement them with a number of new definitions.
The law fixes definitions for parts of the medicinal categories, among which are:
- Orphan;
- biological;
- bioanalogical;
- Homeopathic;
- biotechnological;
- gene therapeutic;
- immunobiological.
Also take notice of the clarification of the following concepts:
- pharmaceutical substance;
- international non-proprietary name;
- the trade name of a medicinal product.
Details about the designation of ownership, as well as the holder of the medicinal product registration certificate, were introduced into the law on the treatment of medicines.
In accordance with the new rules under this subject the following categories are understood: A medicine developer, a manufacturer of medicines, as well as another legal entity that has the right to possess a medicinal product registration certificate. They are responsible for the quality, effectiveness, and safety of medicines.
The medicines capable of replacing one another
What is an interchangeable medicine? It is a medicine to which the therapeutic equivalence or bioequivalence of a correlated medicine is proven.
In this case, this drug must have the following equivalent properties with respect to the first:
- qualitative and quantitative composition;
- active ingredients;
- composition of auxiliary ingredients;
- dosage form;
- way of administration.
The expert commission of the relevant institution implements the analysis of medicines for their interchangeability during the state registration of medicines procedure. The process for determining the interchangeability of medicines for the purpose of further medical application is formed by the special decree of the Government of the Russian Federation, which was adopted in July 2015.
Registration of medicines and implementation of clinical expertise
Some statistics. On the Russian pharmaceutical market, 77% of the drugs are reproduced. 23% are original pharmaceutical products.
The Ministry of Health of the Russian Federation believes that there is an excessive amount of generic drugs on our country's market. When compared with other countries, in Germany there is only 35%, in Japan - 30%, and in the USA - 12%.
Due to this as well as a number of other reasons, active changes in the law on medicine treatment have been made, and the stages for the implementation of clinical trials and the registration of pharmaceutical products have been optimized.
As part of the new changes, there are procedures that also address a number of issues regarding the registration of drugs. They came into force gradually, in 3 stages: From 1 July 2015, from 1 January 2016, and from 1 January 2017.