Regulatory Requirement For Registration of Cardiovascular Drug in CIS Cointries

Abstract

Cardiovascular which is relating to the circulatory system , Which include the heart and blood vessel and transports nutrients and oxygen to the tissue of the body and remove carbon dioxide and other waste from them. Drug which affect the cardiovascular system are among the most commonly used in medicine. Cardiovascular disease includes arteriosclerosis, coronary artery disease, heart valve disease, arrhythmia, heart failure, hypertension, orthostatic hypotension, shock, endocarditis, diseases of the aorta and its branches, disorders of the peripheral vascular system, and congenital heart disease. Amlodipine and valsartan tablets combination is selected for the project and this combination have a different strengths and selected strength is Amlodipine and valsartan (5mg/160mg). Two specific outlines have been distinguished in the growth of organizational representation in the CIS nations. Country like Ukraine, try to find market registration as per European/ICH point of assessment, but others, for example Russian federation and other Republic States impacted by the convention of the Soviet age.Generic drugs in CIS nations are registered and marketed under diverse registration conventions, because of various administrative procedure among the CIS nations.The CIS market is enormous, fast growing and clearly propose huge breaks for pharmaceutical companies.CIS countries consist Armenia, Azerbaijan, Russia, Ukraine, Kazakhstan, Belarus, Moldova, Georgia, Uzbekistan, Tajikistan and Kyrgyzstan and in all CIS countries regulation are semi-regulated and still it is improving. CIS countries having an individual regulation for the drug registration. However, In CIS some countries follow the ICH-CTD and some countries follow the own national format for the drug registration.The variances in the regulations of these countries, sometimes, create uncertainty while gathering a dossier to get the register their medicinal product. Thus this thesis to highlight common regulatory requirement of CIS countries and also differentiate them for better understanding of requirement and contribution the sponsor for filing the dossier in as several countries simultaneously.