Masterarbeit

Regulatory Environment for medicinal products in Russian Federation

Kristina Mumber (2006)

Language: English

With the collapse of the Soviet Union each country started to build its own pharmaceutical market. Russia, which was the main raw materials supplier, remained almost without medicinal products manufacturers.

Healthcare in Russia remains in a poor state. Public hospitals and polyclinics face severe funding shortages and a population in seemingly ever-poorer health. Relying heavily on imports, the 1998 economic crisis left Russia with severe drugs shortages. Prices doubled and imports fell.
The Russian pharmaceutical market has been rapidly expanding over the last several years. This has been the result of a steady increase in the importation of pharmaceuticals. Today, the local drug research and development industry is underdeveloped and weak. The Russian pharmaceutical market is dominated by imported pharmaceuticals. Annual growth in this sector is expected to continue to grow driven by rising incomes, consumer spending, increased efficiency in domestic distribution and increased government funding for drugs.

Recent reforms in healthcare funding and specifically the introduction of the state drug reimbursement system have been the main driving forces of this market in 2005.
Keeping up with legislative changes, presidential decrees and government resolutions is a challenging task. Uneven implementation of laws creates further complications; various officials, branches of government and jurisdictions interpret and apply regulations with little consistency and the decisions of one may be overruled or contested by another. President Putin has stressed the need for consistent application of national law, and his seven regional Presidential Representatives have begun to review regional legislation and regulations to ensure their consistency with national law. The major difficulties in this sector are a lack of transparency in the registration and certification systems and a large percentage of counterfeit medicines.
This master thesis comprises eight main sections: Demographic, Socio-Economic and Political Overview, Organisation of the Health Sector, Russian Pharmaceutical Market, GMP, Registration of Pharmaceutical Products in Russia, Certification of Pharmaceuticals, Pharmacovigilance, and Clinical Research.

The focus lies on medicinal products. The corresponding regulatory procedures for borderline products, cosmetics, biotech products, and medical devices are not part of this thesis.

Pages: 54
Annexes: 16