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Pharmaceutical Product Registration Requirements in ASEAN & CIS Countries

Rao MS, Dixit M, Charyulu RN, Shetty A, Bengre P, Thomas S


The Association of Southeast Asian Nations (ASEAN) and the Commonwealth of Independent States (CIS) nations are two of the emerging pharmaceutical markets. There is a rise in income levels of middle class, rise in health consciousness and growing burden of disease among the aged groups which has led to an increased demand for general and lifesaving medicines in the emerging pharmaceutical markets. This paper approaches the pharmaceutical product registration requirements in ASEAN and CIS countries. Diversity of regulatory requirements is noticed among the two regions; hence it is difficult to obtain marketing approval for pharmaceuticals at the same time in these nations because of unnecessary duplication of work, waste of valuable resources etc. Further attempts needs to be carried out globally to harmonise regulations so that the drug approval process becomes easy and duplication of work and waste of valuable resources is avoided.


Keywords: ASEAN, CIS, CTD, ACTD, harmonisation

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