Why is it necessary to change over to GMP standard in Russia?
Home»GMP»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:
- Protecting market from unfair foreign
producers, which will lead to increase in the share of Russian
products on the market.
- Improvement
of pharmaceutical industry as a whole, according to the world level
- both in its structure, and the quality and nomenclature of
manufactured products.
- 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.