Drug Registration requirements for Pharmaceuticals in Emerging markets

  • Sri Lakshmi Sowjanya Reddy Singam MISS
  • Koushik Yetukuri
  • Rama Rao Nadendla


Registration of pharmaceutical drug products in emerging market is maximum worrying task. Although the requirements are harmonized in regulated international locations by way of CTD (Common technical document) submitting, yet others have considerable diversity in necessities. International conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) has brought regulatory authorities and pharmaceutical industries of US, Japan and Europe collectively for various factors of drug registration. But there is no such harmonized guideline for rising marketplace besides Association of Southeast Asian Nations (ASEAN) and Gulf Co-operation Council (GCC) where harmonization exists in clusters with their mutual situation. Quality, Safety and Efficacy information has significance importance in dossier registration. Pharmaceutical Industries has to conform with regulatory requirement in Emerging market and for betterment of public Health and protection. The business importance of markets is increasing globally. It is important for pharmaceutical enterprise to address the regulatory necessities for betterment of public and to ensure their place in the marketplace. The review additionally explains a short approximately extraordinary regulatory requirement for Registration of drug product in Emerging market and comparative data for registration of dossier software in Emerging marketplace.

Keywords: Dossier Registration, Emerging Markets, GCC, ASEAN, Common technical document (CTD), WHO, Harmonization, Drug Product


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How to Cite
Singam, S. L. S. R., K. Yetukuri, and R. R. Nadendla. “Drug Registration Requirements for Pharmaceuticals in Emerging Markets”. International Journal of Drug Regulatory Affairs, Vol. 8, no. 4, Dec. 2020, pp. 73-82, doi:10.22270/ijdra.v8i4.442.