Regulatory system changes in Russia: A historical review and future perspectives

Raimond Lozda

doi:10.1177/2168479015627853

Regulatory system changes in Russia: A historical review and future perspectives

Raimond Lozda

Research output: Contribution to journal › Review article › peer-review

2 Citations (Scopus)

Abstract

The Russian pharmaceutical market is expected to grow and attract foreign investors. Nevertheless, the frequent changes in regulatory legislation make the process of marketing authorization in Russia much more challenging than in Europe. In the present review, an insight into the practical issues caused by the implementation of the new marketing authorization law from 2010 until now is provided. The outcome of the new law application is contrary to the old one from 1998, which was amended once in 2000. To date, it has already been revised 19 times. The reasons for the frequent amendments as well as future perspectives are provided.

Original language	English
Pages (from-to)	414-418
Number of pages	5
Journal	Therapeutic Innovation and Regulatory Science
Volume	50
Issue number	4
DOIs	https://doi.org/10.1177/2168479015627853
Publication status	Published - Jul 2016
Externally published	Yes

Keywords*

Eurasian economic union
New law
Regulatory affairs
Roszdravnadzor
Russia

Field of Science*

3.1 Basic medicine
3.3 Health sciences

Publication Type*

1.1. Scientific article indexed in Web of Science and/or Scopus database

UN SDGs

This output contributes to the following UN Sustainable Development Goals (SDGs)

Access to Document

10.1177/2168479015627853

Cite this

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title = "Regulatory system changes in Russia: A historical review and future perspectives",

abstract = "The Russian pharmaceutical market is expected to grow and attract foreign investors. Nevertheless, the frequent changes in regulatory legislation make the process of marketing authorization in Russia much more challenging than in Europe. In the present review, an insight into the practical issues caused by the implementation of the new marketing authorization law from 2010 until now is provided. The outcome of the new law application is contrary to the old one from 1998, which was amended once in 2000. To date, it has already been revised 19 times. The reasons for the frequent amendments as well as future perspectives are provided.",

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author = "Raimond Lozda",

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year = "2016",

month = jul,

doi = "10.1177/2168479015627853",

language = "English",

volume = "50",

pages = "414--418",

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T2 - A historical review and future perspectives

AU - Lozda, Raimond

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PY - 2016/7

Y1 - 2016/7

N2 - The Russian pharmaceutical market is expected to grow and attract foreign investors. Nevertheless, the frequent changes in regulatory legislation make the process of marketing authorization in Russia much more challenging than in Europe. In the present review, an insight into the practical issues caused by the implementation of the new marketing authorization law from 2010 until now is provided. The outcome of the new law application is contrary to the old one from 1998, which was amended once in 2000. To date, it has already been revised 19 times. The reasons for the frequent amendments as well as future perspectives are provided.

AB - The Russian pharmaceutical market is expected to grow and attract foreign investors. Nevertheless, the frequent changes in regulatory legislation make the process of marketing authorization in Russia much more challenging than in Europe. In the present review, an insight into the practical issues caused by the implementation of the new marketing authorization law from 2010 until now is provided. The outcome of the new law application is contrary to the old one from 1998, which was amended once in 2000. To date, it has already been revised 19 times. The reasons for the frequent amendments as well as future perspectives are provided.

KW - Eurasian economic union

KW - New law

KW - Regulatory affairs

KW - Roszdravnadzor

KW - Russia

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DO - 10.1177/2168479015627853

M3 - Review article

AN - SCOPUS:84983350488

SN - 2168-4790

VL - 50

SP - 414

EP - 418

JO - Therapeutic Innovation and Regulatory Science

JF - Therapeutic Innovation and Regulatory Science

IS - 4

ER -

Regulatory system changes in Russia: A historical review and future perspectives

Abstract

Keywords*

Field of Science*

Publication Type*

UN SDGs

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