Illustrated drug over-the-counter drug market license application technical guidance.

On July 6, CDE issued the Technical Guidelines for the Registration of Chemical Over-the-Counter Drugs (Draft for Comments) for public commentover-the-counter drugs have clear effectiveness, wide range of safety, low risk of misuse and abuse, indications and usage, and easy for people to judge, use and manage the characteristicsIn addition, over-the-counter drugs in dosage form, specifications, taste, color, odor, packaging and other aspects can better meet the personalized drug needs of the populationthe Measures for the Administration of Drug Registration clearly stipulates that prescription and over-the-counter drugs shall be classified and converted, and if they meet one of the following circumstances, they may directly apply for a license for the listing of over-the-counter drugs:(1) drugs with the same active ingredient, indications (or functional theme), dosage form and specifications, and(2) are listed by the National Drug; The over-the-counter drug as determined by the Supervisory Authority changes the dosage form or specification, without changing the indications (or functional treatment), the dose of administration and the drug in which the drug is administered;(3) a new compound formulation consisting of the active ingredient of the over-the-counter drug as determined by the State Drug Administration, and(iv) other cases where the over-the-counter drug market license is directly declaredthese guidelines are based on the characteristics of China's over-the-counter drug registration declaration, around the above four situations, the development of over-the-counter drug listing license application technical requirementsThis guiding principle focuses on the overall consideration of the technical requirements involved in the over-the-counter drug listing license application, the general principles and standards in research and development, such as the Drug Manufacturing Quality Management Practice (GMP), the Drug Clinical Trial Sypt code (GCP), etc., and implements the principles consistent with the prescription drug listing license applicationThe specific rules ofare as follows:.