DRUG PRODUCT REGISTRATION IN SEMI-REGULATED MARKET

  • Jitendra Kumar Badjatya Department of Pharmacy, JJT University, Chudela, Jhunjhunu, Rajasthan. India
  • Ramesh Bodla (Department of Pharmaceutical Chemistry, DIPSAR New Delhi, India)

Abstract

There found a diversity of regulatory requirement in Semi regulated market. This region consists of mainly the
countries from Asia pacific, Latin America, Eastern Europe, Africa and Gulf countries. Countries from Asia pacific
and Gulf have somewhat harmonized their regulatory environment through The Association of Southeast Asian
Nations (ASEAN) and Gulf Co-operation Council (GCC) organizations, ROW countries yet to be harmonized
regulations in their respective regions.
The urgent requirement to rationalize & harmonize regulation was required by instance of rising cost of health care,
research & development and to meet the public requirement for safe and efficacious treatments to patient in need.
ICH committee has given priority to harmonize the format of reporting data for quality, safety and Efficacy in the
application dossier.
The commercial significance of ROW markets is increasing globally. It is crucial that pharmaceutical companies keep
up-to-date with the latest regulatory developments to ensure their place on the ROW market.
This paper favors the regulatory processes for gaining marketing authorization in ROW countries in terms of
technical data requirement for the dossier.
 

Keywords: DRA, ASEAN, GCC, BMR, ROW, CIS, DMF, TSE/BSE, ICH, FP.

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How to Cite
Badjatya, J. K., and R. Bodla. “DRUG PRODUCT REGISTRATION IN SEMI-REGULATED MARKET”. International Journal of Drug Regulatory Affairs, Vol. 1, no. 2, Feb. 2018, pp. 1-6, doi:10.22270/ijdra.v1i2.3.