Department of Drug Regulatory Affairs, BVDU Poona College of Pharmacy, Pune, Maharashtra, India.
BVDU New Law College, Pune, Maharashtra, India.
Ther Innov Regul Sci. 2020 Jan;54(1):171-176. doi: 10.1007/s43441-019-00042-0. Epub 2020 Jan 6.
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.
在半监管市场中，不同国家对向特定国家或地区出口的注册要求有所不同。本研究的目的是对出口到坦桑尼亚、尼泊尔和柬埔寨的药品注册要求进行比较概述。特别是在非洲地区，东非包括坦桑尼亚在内是医药行业的新兴市场。坦桑尼亚食品和药品管理局是坦桑尼亚的药品监管机构，它遵循文件提交的通用技术文件（CTD）格式。然而，尼泊尔在医药行业方面仍属于发展中国家。尼泊尔的药品管理机构，药品管理局，有自己的国家特定的药品监管指南，但 CTD 格式也可接受用于文件提交。在柬埔寨，药品和食品局是隶属于柬埔寨卫生部的药品监管机构。由于柬埔寨被纳入东南亚国家联盟（东盟）机构，因此它遵循东盟 CTD（ACTD）格式进行文件提交。
