Why is it necessary to change over to GMP standard in Russia?

The Government taken a number of measures to modernize all pharmaceutical market. The main task today is focus on the national pharmaceutical industry to ensure not only internal market but also foreign. In this regard, in September 1, 2010 came into force the Law "Inversion of drugs", according to which all Russian companies will have to go to the GMP standard by 2014.

The issue of introducing GMP rules has a long history.

Necessity transition to GMP for the past few years hotly debated by all members of national and foreign pharmaceutical market. Given the magnitude of the project, including the procedure of the transition is accompanied by resolutions of the Government of the Russian Federation, which currently requires the implementation of certain phases of the modernization of enterprises.

There are several main reasons, motivations for the transition to GMP standard:

  1. Protecting market from unfair foreign producers, which will lead to increase in the share of Russian products on the market.
  2. Improvement of pharmaceutical industry as a whole, according to the world level - both in its structure, and the quality and nomenclature of manufactured products.
  3. Development of national medical and pharmaceutical industry by creating a modern laboratory and technological bases.

Transition to GMP provides a mechanism for protect consumers, not only for Russian companies, but also overseas.


For national pharmaceutical industry compliance GMP standards is a competitive advantage, provided that only about 10% of all businesses operate on standard GMP.

Companies that long before its use in the production of GMP quality standards introduced in the production tough measures for control product quality, today are the leaders.

Health Ministry plans to prepare a number measures to facilitate expensive transition to international standards for the Russian pharmaceutical companies, provided that "The main priority should be the principle of improving the quality of products that meet primarily the interests of the patient and is accompanied by the provision of high quality and decent medical care," - said head of Health Ministry.