| Autor: |
Shelke TV; Department of Drug Regulatory Affairs, BVDU Poona College of Pharmacy, Pune, Maharashtra, India., Khante S; Department of Drug Regulatory Affairs, BVDU Poona College of Pharmacy, Pune, Maharashtra, India., Sarda MB; BVDU New Law College, Pune, Maharashtra, India., Mahadik KR; Department of Pharmaceutical Chemistry, BVDU Poona College of Pharmacy, Pune, Maharashtra, India., Gaikwad VL; Department of Pharmaceutics, BVDU Poona College of Pharmacy, Erandwane, Pune, 411038, Maharashtra, India. vinod_gaikwad29@yahoo.com. |
| Abstrakt: |
In the semiregulated market, different countries have varying requirements of registration for export to such a specific country or region. The objective of the present study is to give a comparative overview of pharmaceutical registration requirements for export to Tanzania, Nepal, and Cambodia. In the African region especially, east Africa including Tanzania is an emerging market for pharmaceuticals. The Tanzania Food and Drugs Authority is the drug regulatory body in Tanzania and it follows the Common Technical Document (CTD) format for dossier submission. However, Nepal is still a developing country with respect to the pharmaceutical sector. The drug governing body in Nepal, Department of Drug Administration, has its own nation-specific guidelines for drug regulation, but the CTD format is also acceptable for dossier submission. In Cambodia, the Department of Drugs and Food is the drug regulatory authority that comes under the Ministry of Health of Cambodia. As Cambodia is included in the Association of Southeast Asian Nations (ASEAN) body, it follows the ASEAN CTD (ACTD) format for dossier submission. |
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