Introduction of OTC Monograph System in USA and Its Enlightenment to China
- VernacularTitle:美国非处方药专论制度介绍及对我国的启示
- Author:
Yufei ZHANG
1
;
Chendong DONG
2
;
Zizhe WANG
1
;
Ningying MAO
1
Author Information
1. School of International Pharmaceutical Business，China Pharmaceutical University，Nanjing 211198，China
2. China Resources Sanjiu Medical & Pharmaceutical Co.，Ltd.，Guangdong Shenz hen 518110，China
- Publication Type:Journal Article
- Keywords:
OTC drug;
Registration and evaluation;
Monograph syst em;
USA;
Enlightenment
- From:
China Pharmacy
2020;31(7):769-773
- CountryChina
- Language:Chinese
-
Abstract:
OBJECTIVE：To put forward some suggestions for the implementation of OTC monograph in China. METHODS ： Literature research was used to comprehensively review the concept ，emergence and development ，function of OTC monograph in USA；referring to experience in USA ，the necessity and feasibility of monograph system for OTC registration and evaluation in China were explored ，and some suggestions were put forward to the implementation of OTC monograph in China. RESULTS & CONCLUSIONS：OTC monograph in USA refers to the regulatory standards that should be followed when selling OTC products not included in new drug applications. The monograph originates from the re-evaluation project of the effectiveness of OTC drugs ， which plays a special role in accelerating the drug marketing and promoting product innovation. The OTC monograph system is necessary to help to optimize the OTC registration and evaluation ，but at present ，the conditions to establish and implement OTC monograph are not yet ripe in China. Based on the optimization of resource allocation and infrastructure construction ，national OTC drug management experience ，OTC monograph can play a full part in OTC registration and evaluation ，in terms of carrying out in-depth research ，taking pilot test ，improving risk management system and enhancing drug review resource allocation ability.
