Current situation research on the optimization path of market access for over-the-counter drugs in China and suggestions for the application of international experience
- VernacularTitle:我国非处方药市场准入优化路径现状调研及国际经验应用建议
- Author:
Na LU
1
;
Haiping HAO
2
;
Zuoqi DING
1
Author Information
1. School of International Pharmaceutical Business，China Pharmaceutical University，Nanjing 210009，China
2. School of Pharmacy，China Pharmaceutical University，Nanjing 210009，China
- Publication Type:Journal Article
- Keywords:
OTC;
market access;
registration review;
path optimization;
international experience
- From:
China Pharmacy
2025;36(12):1417-1423
- CountryChina
- Language:Chinese
-
Abstract:
OBJECTIVE To provide a reference for optimizing the market access process for over-the-counter drugs （OTC） in China. METHODS Based on literature review， questionnaire survey was designed and distributed via the Wenjuanxing platform to respondents from pharmaceutical enterprises， drug regulatory agencies， industry associations， medical institutions and universities. The collected survey data were then subjected to statistical analysis. RESULTS A total of 154 questionnaires were collected， all of which were valid. Among the respondents， 58.5% were from pharmaceutical enterprises， 18.8% were from the field of drug regulation， and the remaining 22.7% were from universities and medical institutions. More than half of the respondents had been working for 10 years or more. A total of 89.6% of the respondents called for the establishment of an independent review system for OTC. Additionally， 88.3% believed it was necessary to establish an OTC monograph system based on China’s national conditions. Meanwhile， 73.4% of respondents believed it was necessary to standardize the monograph inclusion procedures and processes， while 77.3% thought the specific process for switching prescription drugs to OTC status should be improved. Furthermore， 91.0% of the respondents considered that real-world data/evidence could contribute to simplifying the OTC market approval pathway， although challenges related to data quality and data accessibility were acknowledged. CONCLUSIONS The review cycle for China’s OTC market access mechanism is relatively long. A localized adaptation and optimization path of “institutional reconstruction-technological innovation-regulatory innovation” in a trinity is proposed to provide a decision-making basis for establishing a scientific and efficient OTC regulatory system with international experience serving as a reference.
