WJPR Citation New

  All Since 2011
 Citation  2903  2393
 h-index  27  24
 i10-index  68  60

Login

Best Paper Awards

World Journal of Pharmaceutical Research (WJPR) will give best paper award in every issue in the form of money along with certificate to promote research activity of scholar.
            Best Paper Award :

Download Article: Click Here

Search

Track Your Article

Abstract

REGULATIONS AND REGISTRATION PROCESS OF MEDICINAL PRODUCTS AND MEDICAL DEVICES IN CIS COUNTRIES

Shaik Ayesha BI*, M. V. Nagabhushanam, G. Ramakrishna, P. V. Sivakrishna, Brahmaiah Bonthagarala

Abstract

The CIS region has a potential market for India. The registration of the drug products in CIS regions is a challenging task because these countries have no harmonized regulatory organization. The CIS region includes 12 countries such as Russia, Kyrgyzstan, Ukraine, Uzbekistan, Kazakhstan, Tajikistan, Turkmenistan, Armenia, Azerbaijan, Belarus, Georgia and Moldova, which require different regulatory guidelines for medicinal product registration as per their FDA guidelines. The different guidelines for the same region become a challenging task for the manufacturer and exporter. The registration of the same product for different countries of CIS is not possible with the same dossier due to the lack of their regulatory harmonization. These countries obey their country-specific dossier format, so to target these market manufacturers and exporters needs to submit different dossier documents for different countries. But Ukraine and Kazakhstan have harmonization and it varies in Uzbekistan and Tajikistan. Ukraine and Kazakhstan are also imposing strict rules and expecting USFDA level documents for approval. The overall conclusion is that harmonization in CIS is highly imbalanced, which affects both time and cost for product registration. Harmonization is the need of the era for easy product registration, and it will be beneficial for the manufacturer, regulator, importer, exporter, and to access medicines of high public health value.

Keywords: CIS region, drug product, guidelines, harmonization, regulatory, registration.


[Full Text Article]

Call for Paper

World Journal of Pharmaceutical Research (WJPR)
Read More

Email & SMS Alert

World Journal of Pharmaceutical Research (WJPR)
Read More

Article Statistics

World Journal of Pharmaceutical Research (WJPR)
Read More

Online Submission

World Journal of Pharmaceutical Research (WJPR)
Read More