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Over-the-counter medicines have clear effectiveness, wide range of safety, low risk of misuse and abuse, determination of adaptive and usage usage, and are easy for people to judge, use and manage on their own.
addition, over-the-counter drugs in dosage form, specifications, taste, color, odor, packaging and other aspects can better meet the personalized needs of the population.
The Measures for the Administration of Drug Registration clearly stipulate that prescription drugs and over-the-counter drugs shall be subject to classification registration and conversion management, and if they meet one of the following conditions, they may directly apply for an over-the-counter drug listing license: (1) drugs that are already listed on the market with the same active ingredients, adaptive substances (or functional treatments), dosage forms and specifications within the territory; (2) Drugs that change dosage forms or specifications of over-the-counter drugs as determined by the State Drug Administration, but do not change the adaptation (or functional treatment), dosage and dosage methods of administration; (3) new compound preparations consisting of active ingredients of over-the-counter drugs determined by the State Drug Administration; and (4) other cases where over-the-counter drug listing permits are directly declared.
based on the characteristics of China's over-the-counter drug registration and declaration, around the above four cases, the formulation of over-the-counter drug licensing applications for technical requirements.
This guiding principle focuses on the overall consideration of the technical requirements involved in over-the-counter drug licensing applications, general principles and standards in research and development, such as the Drug Manufacturing Quality Management Practice (GMP), the Drug Clinical Trial Quality Management Practice (GCP), and the implementation of principles consistent with prescription drug listing licensing applications.
rules are as follows:
