Background:
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.
Conclusion:
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.
EBF recommendation on practical management of critical reagents for antidrug antibody ligand-binding assays
