Technical Guidelines for Marketing and Registration of
Over-The-Counter Chemical Drugs
(Draft for Comments)
Over-the-counter (OTC) drugs refer to drugs approved by the NMPA, which are not required to be prescribed by medical practitioners or assistant medical practitioners, and can be purchased and used by consumers at their own discretion. OTC drugs are characterized by clear effectiveness, a wide range of safety, low risk of misuse and abuse, fixed indications and usage, and easy to be judged, used and managed by people at their own discretion. In addition, OTC drugs can better meet the individualized drug demands of the population in terms of dosage form, strength, taste, color, odour, and package.
The Provisions for Drug Registration (Order No. 27 of the State Administration for Market Regulation) clearly stipulates that prescription drugs and OTC drugs shall be subject to classified registration and conversion management. Under any of the following circumstances, an application for marketing authorization of an OTC drug may be directly filed: (1) There is already an OTC drug marketed with the same active ingredients, indications (or functions), dosage forms and strengths as the drug in the territory; (2) The dosage form or strength is changed for an OTC drug determined by NMPA, but the indication (or function), dosage or route of administration of the drug is not changed; (3) A new compound preparation composed of active ingredients of an OTC drug determined by NMPA is used; (4) Other circumstances for directly filing an application for OTC drug marketing authorization.