Pharmaceutical Product Registration Requirements in ASEAN & CIS Countries

Authors

  • Rao MS Department of Drug Regulatory Affairs, NGSM Institute of Pharmaceutical Sciences, Nitte University, Mangalore-575018, Karnataka, India
  • Dixit M Department of Drug Regulatory Affairs, NGSM Institute of Pharmaceutical Sciences, Nitte University, Mangalore-575018, Karnataka, India
  • Charyulu RN Department of Drug Regulatory Affairs, NGSM Institute of Pharmaceutical Sciences, Nitte University, Mangalore-575018, Karnataka, India
  • Shetty A Department of Drug Regulatory Affairs, NGSM Institute of Pharmaceutical Sciences, Nitte University, Mangalore-575018, Karnataka, India
  • Bengre P Department of Drug Regulatory Affairs, NGSM Institute of Pharmaceutical Sciences, Nitte University, Mangalore-575018, Karnataka, India
  • Thomas S Department of Drug Regulatory Affairs, NGSM Institute of Pharmaceutical Sciences, Nitte University, Mangalore-575018, Karnataka, India

DOI:

https://doi.org/10.37591/rrjodfdp.v1i2.311

Abstract

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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Published

2019-03-19

Issue

Vol. 1 No. 2 (2014)

Section

Review Article

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