OBJECTIVE

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To provide a reference for optimizing the market access process for over-the-counter drugs （OTC） in China.

METHODS

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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

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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

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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.