CDE PublicLy Solicits technical guidelines for the registration of chemical over-the-counter drug market (draft for comments)

Introduction: Aimed at coordinating the implementation of the Measures for the Administration of Drug Registrationthe drafting of the Technical Guidelines for the Registration of Chemical Over-the-Counter Drug Market (Draft for Comments) drafting instructions
In order to cooperate with the implementation of the Measures for the Administration of Drug Registration, standardize the research and development of over-the-counter drug in China, further clarify the requirements for the registration of chemical over-the-counter drug market, and the Drug Review Center has drafted the Technical Guidelines for the Registration of Chemical Over-the-Counter Drug Marketing, which forms a draft of the draftThe situation is explained as follows:, background and purpose
over-the-counter drugs have clear effectiveness, wide range of safety, low risk of misuse and abuse, indications and usage to determine, and easy for the population 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, prescription and over-the-counter drugs shall be classified and converted, and if they meet one of the following conditions, they may directly apply for a license for the listing of over-the-counter drugs: (1) drugs listed on the market by the same active ingredient, indications (or functional theme), dosage form and specification; The over-the-counter drug determined by the Supervisory Authority changes the dosage form or specification, but does not alter 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 ingredients of the over-the-counter drug as determined by the State Drug Administration; and (4) other cases where the license for the market for over-the-counter drugs 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 requirementsThese Guidelines focus on the overall considerations in the technical requirements involved in the over-the-counter drug listing license application, and the general principles and standards in research and development, such as the Drug Manufacturing Quality Management Practice (GMP), the Pharmaceutical Clinical TrialS Quality Management Practice (GCP), etc., and enforce the principles consistent with the prescription drug listing license applicationthese guidelines apply to chemical and pharmaceutical over-the-counter drugs2Drafting process
This guiding principle is led by a clinical department of chemical drugs, and the participating departments include: Chemical Pharmacology Department I and Ii, Department of Pharmacology, Department of Statistics and Clinical Pharmacology, Business Management Department, Quality DepartmentThe development of these guidelines was initiated in January 2020 and formed in May 2020, after discussion within the Drug Review Center, reviewed by the Technical Committee, and solicited the opinions of some industry experts and over-the-counter drug research and development enterprises, main contents and instructions
This guiding principle includes an overview, overall consideration, technical requirements, schedules and by-laws, combined with the characteristics of chemical over-the-counter drugs, from the pharmacology, pharmacology, clinical pharmacology, clinical aspects of the general principles of research and evaluation The study requirements for different declaration situations are detailed in the schedule Technical Guidelines for the Registration of Chemical Over-the-Counter Drugs (Draft for Comments) , Outline Over-the-Counter Drug refers to drugs approved by the State Drug Administration and do not require prescriptions from medical practitioners and medical assistants, and consumers may judge, purchase and use drugs at their own discretion Over-the-counter drugs have the characteristics of clear effectiveness, wide range of safety, low risk of misuse and abuse, indications and usage, and easy for people to judge, use and manage In 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 population the Measures for the Administration of Drug Registration (State Administration of Market Supervision and Administration Order No 27) clearly stipulates that prescription and over-the-counter drugs shall be classified and converted, and if they meet one of the following conditions, they may directly apply for a license for the listing of over-the-counter drugs: (i) drugs that have the same active ingredient, indications (or functional treatment), dosage type and specification signed on the market; 2) The over-the-counter drug regulatory authority shall change the dosage form or specification, but not the indications (or functional treatment), the dosage of the drug and the drug in which the drug is administered; (3) the new compound preparation consisting of the active ingredients of the over-the-counter drug as determined by the State Drug Administration; and (4) other cases where the license for the market for over-the-counter drugs is directly declared these 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 requirements These Guidelines focus on the overall considerations in the technical requirements involved in the over-the-counter drug listing license application, and the general principles and standards in research and development, such as the Drug Manufacturing Quality Management Practice (GMP), the Pharmaceutical Clinical TrialS Quality Management Practice (GCP), etc., and enforce the principles consistent with the prescription drug listing license application generally, over-the-counter drugs include chemicals, as well as traditional Chinese and natural medicines This guideline applies only to chemical and pharmaceutical over-the-counter drugs , the overall consideration according to the characteristics of over-the-counter drugs, there are the following overall considerations: (1) recognized on the basis of the listed over-the-counter drugs, combined with indications and variety characteristics, the development of suitable for China's population preferences and drug habits and controlled quality of over-the-counter drug varieties (ii) the evaluation of the clinical value (clinical needs) of over-the-counter drugs to meet the personalized drug demand of the chinese population, and not to make an advantageous comparison (iii) the long-term extensive domestic and foreign experience can be used as important evidence to assess the risk of over-the-counter drug listing in China and to consider appropriate simplification or exemption from listing registration-related clinical studies based on the results of the assessment (4) For over-the-counter drug varieties that are difficult to identify the reference formulation, the quality improvement method may be used to evaluate generic drugs under the premise of recognizing clinical value (clinical needs) Technical Requirements In accordance with article 36 of the Measures for the Administration of Drug Registration, the four cases in which an application for an over-the-counter drug listing permit can be directly submitted, respectively, from the pharmaceutical research, pharmacological toxicology research, clinical pharmacology research and clinical research to make recommendations on the relevant technical requirements, and the specific research requirements corresponding to the four situations are detailed in the schedule (i) Pharmaceutical research quality control is the basic requirement to support drug registration and listing The quality control requirements for over-the-counter drugs are consistent with those of prescription drugs For the varieties of reference preparation signed as approved, the comparative study of the pharmaceutical ratio should be carried out Considering that some over-the-counter drugs are on the market early and quality studies are inadequate, some indicators or limits of quality control are evaluated with current technical requirements For over-the-counter drug varieties that are difficult to identify the analogy, the quality improvement can be evaluated by means of quality improvement under the premise of recognition of clinical value (clinical needs) (ii) Pharmacological Toxicology Research for over-the-counter drug varieties that have long been widely used by people with a large base or have higher quality clinical research evidence, generally no longer require preclinical pharmacological research Where insufficient evidence is available to support human safety or efficacy, appropriate preclinical pharmacological toxicology studies should be considered to provide evidence of non-clinical efficacy and safety to support subsequent benefit risk assessments for human trials or human applications (iii) Clinical Pharmacology Research the development of generic over-the-counter drugs, followthe principles consistent with prescription drugs, and prove the biological equivalence with the reference agent through appropriate research For over-the-counter generics with local effects, bioequivalence studies may be exempted on the premise that the quality of the drug and local safety are basically consistent with the reference formulation the necessary bioequivalence or bioavailability comparison tests are required for over-the-counter drug varieties that change dosage or specification For new compounds consisting of identified over-the-counter active ingredients, consideration needs to be given to bioequivalence studies compared to unilateral use, as well as necessary drug interaction studies to declare new over-the-counter active ingredients, changes in the route of administration or the use of non-prescription drug (drug users), the necessary clinical pharmacological research should be carried out to examine the autokinetic characteristics of the human body, to support evidence of possible changes in the dose or mode of administration (iv) Clinical Research for varieties with strong evidence to support the safety and efficacy of over-the-counter drug pathways, the data obtained should be used to support registration, avoid unnecessary clinical studies and simplify the necessary clinical studies For over-the-counter drugs that have been listed abroad, we need to combine the time of listing approval, the basis of pre-market research, post-market application, and consider the clinical value (clinical needs) and the requirements of China's listing registration research For over-the-counter drugs with a good basis for overseas listing, you can refer to the Technical Guidelines for Accepting Overseas Clinical Trial Data, and the varieties that meet the requirements may be exempted from clinical studies, or only conduct validation studies of efficacy for over-the-counter drug varieties that change or change size, as well as new compounds consisting of identified over-the-counter active ingredients, there is no need to demonstrate clinical advantage sane with clear clinical value (clinical requirements) and no increased safety risk only change the taste, color, odor, coolness, consistency, hardness, packaging specifications, etc., and the change does not affect the quality and efficacy characteristics of the drug over-the-counter generic varieties, in addition to the necessary research to carry out imitation, no additional clinical research is required for some over-the-counter drug varieties with special characteristics in dosage form, drug delivery device, method of administration, etc., should provide additional basis for whether it conforms to the drug habits and convenience of the chinese population schedule of :