1. Industry authorities
Industry authorities
Source**: Guanyan Report Network.
Second, the industry supervision system
China has established a relatively complete system of drug regulatory laws and regulations, involving drug classification management, registration management, production management, quality management, etc., covering the whole process of drug research and development, production, circulation and use, and the specific laws and regulations and main contents are as follows:
(1) Drug classification management system
The Drug Administration Law of the People's Republic of China stipulates that the state implements a classified management system for prescription drugs and over-the-counter drugs. The specific measures shall be formulated by the drug regulatory department in conjunction with the competent health department.
Measures for the Classification and Management of Prescription Drugs and Non-prescription Drugs (for Trial Implementation) is a drug classification management method issued by the State Drug Administration. According to the different varieties, specifications, indications, dosages and routes of administration of drugs, drugs are managed as prescription drugs and over-the-counter drugs. Prescription drugs must be prescribed by a licensed physician or licensed physician assistant before they can be dispensed, purchased, and usedOver-the-counter drugs do not require a prescription from a licensed physician or licensed physician assistant to be used at your own discretion. According to the safety of drugs, over-the-counter drugs are divided into two categories: A and B. Wholesale enterprises dealing in prescription drugs and over-the-counter drugs and retail enterprises dealing in prescription drugs and Class A non-prescription drugs must have a "Pharmaceutical Business Enterprise License". Other commercial enterprises approved by the provincial drug regulatory department or its authorized drug regulatory department may retail Class B non-prescription drugs. Commercial enterprises retailing Class B OTC drugs must be equipped with full-time personnel with a high school education or above, who have passed the examination and obtained the employment certificate by the provincial drug regulatory department or its authorized drug regulatory department after professional training.
(2) Drug marketing and registration management system
Drug registration refers to the activities in which the drug registration applicant submits applications for drug clinical trials, drug marketing authorization, re-registration and supplementary applications in accordance with legal procedures and relevant requirements, and the drug regulatory department reviews the safety, effectiveness and quality controllability based on laws and regulations and existing scientific cognition to decide whether to agree to the application.
The Drug Administration Law of the People's Republic of China stipulates that drugs marketed in China shall be approved by the drug regulatory department and obtain a drug registration certificate.
The Measures for the Administration of Drug Registration issued by the State Administration for Market Regulation stipulate that when applying for drug registration, true, sufficient and reliable data, materials and samples shall be provided to prove the safety, effectiveness and quality controllability of the drug. The drug registration certificate is valid for five years, and the holder of the drug registration certificate shall continue to ensure the safety, efficacy and quality controllability of the marketed drug during the validity period, and apply for drug re-registration six months before the expiration of the validity period. The State Drug Administration has established a review and approval system for chemical raw materials, excipients and packaging materials and containers in direct contact with drugs. When approving drug preparations, chemical raw materials are reviewed and approved, and relevant excipients, packaging materials and containers that are in direct contact with drugs are reviewed together. The Center for Drug Evaluation (CDE) shall establish a registration platform for the information of packaging materials and containers of chemical raw materials, excipients and drugs in direct contact, publicize the relevant registration information for the relevant applicants or holders to choose, and conduct a review in connection with the review of the registration application of the relevant drug preparations.
(3) Drug marketing authorization holder system
A marketing authorization holder refers to an enterprise or drug development institution that has obtained a drug registration certificate. After the applicant obtains the drug registration certificate, he or she is the marketing authorization holder.
The Drug Administration Law of the People's Republic of China stipulates that the marketing authorization holder shall be liable for the non-clinical research, clinical trials, production and operation, post-marketing research, adverse reaction monitoring, reporting and treatment of the drug in accordance with the provisions of this law. The marketing authorization holder can produce the drug on its own or entrust the drug manufacturer to produce it. If the marketing authorization holder produces the drug on its own, it shall obtain the drug production license in accordance with the provisions of this Law;If the production is entrusted, it shall be entrusted to a qualified drug manufacturer. The marketing authorization holder and the entrusted manufacturer shall sign the entrustment agreement and the quality agreement, and strictly perform the obligations agreed in the agreement. The marketing authorization holder of a drug may sell the drugs for which it has obtained a drug registration certificate on its own, or may entrust a drug business enterprise to sell them. If a marketing authorization holder engages in drug retail activities, it shall obtain a drug business license.
(4) Drug production licensing system
The Drug Administration Law of the People's Republic of China stipulates that to engage in drug production activities, it shall be approved by the people's drug regulatory department of the province, autonomous region and municipality directly under the Central Government to obtain a drug production license. Without a drug production license, no drug shall be produced. Those engaged in drug production activities shall comply with the good manufacturing practices for drug production, establish and improve the drug production quality management system, and ensure that the whole process of drug production continues to meet the statutory requirements. The Measures for the Supervision and Administration of Drug Production issued by the State Administration for Market Regulation have detailed provisions on drug production licensing, production management, supervision and inspection, etc.
(5) Drug business licensing system
The Drug Administration Law of the People's Republic of China stipulates that to engage in drug wholesale activities, it shall be approved by the people's drug regulatory department of the province, autonomous region and municipality directly under the Central Government to obtain a drug business license. To engage in drug retail activities, it shall be approved by the local people's drug regulatory department at or above the county level where it is located, and obtain a drug business license. Without a drug business license, no drug shall be dealt.
The Measures for the Administration of Drug Business Licenses issued by the former State Food and Drug Administration stipulate that the food and drug supervision and administration departments at the municipal level divided into districts or the county-level food and drug supervision and administration departments directly set up by the food and drug supervision and administration departments of provinces, autonomous regions and municipalities directly under the Central Government are responsible for the issuance, renewal, change and daily supervision and management of the "Drug Business License" of drug retail enterprises within their jurisdiction.
(6) Drug quality management system
The Drug Administration Law of the People's Republic of China stipulates that the drug regulatory department shall inspect the compliance of drug marketing authorization holders, drug manufacturers, drug trading enterprises, drug non-clinical safety evaluation research institutions, and drug clinical trial institutions with good manufacturing practices, good management practices for drug business, good management practices for drug non-clinical research, and good management practices for drug clinical trials, and supervise their continuous compliance with statutory requirements.
Before the implementation of the new version of the Drug Administration Law of the People's Republic of China, drug manufacturers and drug trading and circulation enterprises need to implement a certification management system in accordance with the requirements of the "Good Manufacturing Practice for Drugs" and the "Good Practice for Drug Operation", and issue GMP and GSP certificates respectively. According to the announcement of the State Food and Drug Administration on matters related to the implementation of the Drug Administration Law of the People's Republic of China (No. 103 of 2019), from December 1, 2019, the GMP and GSP certification of drugs will be cancelled, the application for GMP and GSP certification will no longer be accepted, and the GMP and GSP certificates of drugs will no longer be issued. Applications for certification accepted before December 1, 2019 shall be handled in accordance with the relevant provisions of GMP and GSP certification of original drugs. If the on-site inspection is completed before December 1, 2019 and meets the requirements, the drug GMP and GSP certificates will be issued. Where on-site inspections are required by current regulations, on-site inspections shall continue to be carried out after December 1, 2019, and the results of on-site inspections shall be notified to the enterprise;If the inspection does not meet the requirements, it shall be dealt with in accordance with the provisions and in accordance with law.
Although GMP certification and GSP certification have been cancelled, the drug regulatory department has inspected the implementation of GMP and GSP at any time, strengthened the dynamic management during and after the event, and strengthened the supervision of enterprises.
(7) National drug standards
The Drug Administration Law of the People's Republic of China stipulates that drugs shall comply with national drug standards. If the drug quality standard approved by the drug regulatory department is higher than the national drug standard, it shall be implemented in accordance with the approved drug quality standard;If there is no national drug standard, it shall meet the approved drug quality standards. **The Pharmacopoeia of the People's Republic of China and the drug standards promulgated by the drug regulatory department are the national drug standards.
3. Major laws, regulations and policies of the industry
Policies such as the "Healthy China 2030" Planning Outline, the National Nutrition Plan (2017-2030) and the "Outline of the 13th Five-Year Plan for National Economic and Social Development of the People's Republic of China" have further highlighted the dominant role of prevention in the construction of "Healthy China", guided the people to strengthen health awareness, and the focus of healthy consumption demand will shift from disease treatment to prevention and health care. The deepening of these policies will bring broader market demand for OTC drug products. **Opinions on Accelerating the Development of Circulation and Promoting Commercial Consumption (Guo Ban Fa 2019 No. 42) issued by the General Office, the "National Plan for Deepening the Reform of "Delegating Power, Delegating Power and Improving Services" and Optimizing the Business Environment (Guo Ban Fa 2020 No. 43) and the supporting measures of various localities to support the liberalization of the operation of Class B non-prescription drugs.
The main laws and regulations of the industry
Source**: Guanyan Report Network.
Major policies of the industry
Source**: WWTQ
Note: The above information is for reference only, please refer to the body of the report for details.
The "In-depth Research and Development Prospect of China's OTC Drug Industry (2023-2030)" released by Guanyan Report Network covers the latest industry data, market hotspots, policy planning, competitive intelligence, market prospects**, investment strategies, etc. It is supplemented by a large number of intuitive charts to help enterprises in the industry accurately grasp the development trend of the industry, market trends, and correctly formulate corporate competitive strategies and investment strategies. Based on authoritative data released by the National Bureau of Statistics, the General Administration of Customs and the State Information Center, this report combines the environment in which the industry is located, and conducts market research and analysis from multiple perspectives such as theory to practice, from macro to micro.
The industry report is one of the important decision-making bases for enterprises, relevant investment companies and first-class departments in the industry to accurately grasp the development trend of the industry, gain insight into the industry competition pattern, avoid business and investment risks, and formulate correct competition and investment strategy decisions. This report is an indispensable and important tool for a comprehensive understanding of the industry and for investing in the industry. Over the years, Guanyan has provided professional industry analysis reports for tens of thousands of enterprises, consulting institutions, financial institutions, industry associations, individual investors, etc., and its customers include Huawei, PetroChina, China Telecom, China Construction, HP, Disney and other leading enterprises at home and abroad, and have been widely recognized by customers.
Outline of the Table of Contents
Chapter 1 2019-2023An overview of the development of China's OTC drug industry
Section 1 Overview of the development of the over-the-counter drug industry.
1. Relevant definitions of the over-the-counter drug industry.
2. Analysis of the characteristics of over-the-counter drugs.
3. Introduction to the basic situation of the over-the-counter drug industry.
Fourth, the business model of the over-the-counter drug industry.
1. Production mode.
2. Procurement mode.
3. Sales and service model.
5. Analysis of the main demand of the over-the-counter drug industry
Section 2 Life Cycle Analysis of China's OTC Drug Industry.
1. Overview of the life cycle theory of the OTC drug industry.
2. Life cycle analysis of the OTC drug industry.
Section 3 Analysis of economic indicators of the non-prescription drug industry.
1. Profitability analysis of the OTC drug industry.
2. Economic cycle analysis of the OTC drug industry.
3. Analysis of the improvement space of added value in the non-prescription drug industry.
Chapter 2 2019-2023Analysis of the market development status of the global OTC drug industry
Section 1 Review of the development history of the global OTC drug industry.
Section 2 Market size and regional distribution of the global OTC drug industry.
Section 3 Regional Market Analysis of Asian OTC Drug Industry.
1. Analysis of the market status of the Asian OTC drug industry.
2. Analysis of the market size and market demand of the Asian OTC drug industry.
3. Analysis of the market prospect of the Asian OTC drug industry.
Section 4 Regional Market Analysis of North American OTC Drug Industry.
1. Analysis of the market status of the North American OTC drug industry.
2. Analysis of the market size and market demand of the North American OTC drug industry.
3. Analysis of the market prospect of the North American OTC drug industry.
Section 5 Regional Market Analysis of the European OTC Drug Industry.
1. Analysis of the market status of the European OTC drug industry.
2. Analysis of the market size and market demand of the European OTC drug industry.
3. Analysis of the market prospect of the European OTC drug industry.
Section 6 Distribution trend of the world OTC drug industry from 2023 to 2030**.
Section 7 Global OTC Drug Industry Market Size, 2023-2030**.
Chapter IIIAnalysis of the industrial development environment of China's non-prescription drug industry
Section 1 Analysis of China's Macroeconomic Environment.
Section 2 Analysis of the impact of China's macroeconomic environment on the OTC drug industry.
Section 3 Analysis of the policy environment of China's non-prescription drug industry.
1. The current situation of the industry regulatory system.
Second, the main policies and regulations of the industry.
3. Main industry standards.
Section 4 Analysis of the impact of the policy environment on the OTC drug industry.
Section 5 Analysis of the Industrial and Social Environment of China's Non-prescription Drug Industry
Chapter IVThe situation of China's OTC drug industry
Section 1 Introduction to the development of China's non-prescription drug industry.
1. Review of the development process of the industry.
2. Analysis of industry innovation.
3. Analysis of the development characteristics of the industry.
Section 2 Market Size Analysis of China's OTC Drug Industry.
1. Factors affecting the market size of China's OTC drug industry.
2. The market size of China's over-the-counter drug industry.
3. Analysis of the market size of China's over-the-counter drug industry.
Section 3 Analysis of China's Non-prescription Drug Industry**.
1. The largest scale of China's over-the-counter drug industry.
2. Characteristics of China's over-the-counter drug industry.
Section 4 Analysis of the demand of China's non-prescription drug industry.
1. The demand scale of China's over-the-counter drug industry.
2. Characteristics of demand in China's non-prescription drug industry.
Section 5 Analysis of the Supply and Demand Balance of China's Non-prescription Drug Industry.
Chapter 5Analysis of the industrial chain and market segments of China's OTC drug industry
Section 1 Overview of the industrial chain of China's non-prescription drug industry.
1. Introduction to the principle of the industrial chain model.
Second, the operation mechanism of the industrial chain.
3. The industrial chain of the over-the-counter drug industry**.
Section 2 Analysis of the industrial chain of China's non-prescription drug industry.
First, the development status of upstream industries.
2. Analysis of the impact of the upstream industry on the OTC drug industry.
Third, the development status of downstream industries.
4. Analysis of the impact of downstream industries on the OTC drug industry.
Section 3 Analysis of market segments of China's over-the-counter drug industry.
First, market segment one.
Second, market segment two.
Chapter 6 2019-2023Market competition analysis of China's OTC drug industry
Section 1 Analysis of the current situation of competition in China's non-prescription drug industry.
1. Analysis of the competitive landscape of China's non-prescription drug industry.
Second, the main products of China's non-prescription drug industry
Section 2 Analysis of the concentration of China's OTC drug industry.
1. Analysis of the influencing factors of market concentration in China's over-the-counter drug industry.
2. Analysis of the market concentration of China's non-prescription drug industry.
Section 3 Analysis of the Competitive Characteristics of China's OTC Drug Industry.
1. Characteristics of regional distribution of enterprises.
Second, the distribution characteristics of enterprise scale.
3. Characteristics of the distribution of enterprise ownership.
Chapter 7 2019-2023Model analysis of China's OTC drug industry
Section 1 Analysis of the Competition Structure of China's OTC Drug Industry (Porter's Five Forces Model).
1. The principle of Porter's Five Forces Model.
Second, the bargaining power.
3. Bargaining power of buyers.
Fourth, the threat of new entrants.
5. Threat of substitutes.
Sixth, the degree of competition in the same industry.
7. Conclusion of Porter's Five Forces Model.
Section 2 SWOT Analysis of China's OTC Drug Industry.
1. Overview of the SOWT model.
Second, the analysis of industry advantages.
Third, the disadvantages of the industry.
Fourth, industry opportunities.
5. Industry threats.
6. SWOT analysis conclusions of China's OTC drug industry.
Section 3 Analysis of the Competitive Environment of China's OTC Drug Industry (PEST).
1. Overview of the PEST model.
Second, policy factors.
3. Economic factors.
Fourth, social factors.
Fifth, technical factors.
6. Conclusions of PEST model analysis.
Chapter 8 2019-2023Analysis of the demand characteristics and dynamics of China's non-prescription drug industry
Section 1 Market dynamics of China's OTC drug industry.
Section 2 Analysis of the characteristics of the consumer market of China's non-prescription drug industry.
1. Demand preference.
2. Preferences.
3. Brand preference.
4. Other preferences.
Section 3 Analysis of the cost structure of the over-the-counter drug industry.
Section 4 Analysis of influencing factors in the non-prescription drug industry.
1. Supply and demand factors.
Second, the cost factor.
3. Other factors.
Section 5 Analysis of the current situation of China's non-prescription drug industry.
Section 6 Average Trend of China's Non-prescription Drug Industry.
1. Analysis of the average trend of China's non-prescription drug industry.
2. Factors influencing the average ** change in China's non-prescription drug industry.
CHAPTER IXMonitoring of the operation data of the industry to which China's non-prescription drug industry belongs
Section 1 Analysis of the overall scale of China's non-prescription drug industry.
1. Analysis of the number and structure of enterprises.
2. Analysis of the scale of industry assets.
Section 2 Analysis of the production, sales and expenses of China's non-prescription drug industry.
1. Current assets.
Second, sales revenue analysis.
3. Liability analysis.
Fourth, the analysis of profit scale.
5. Analysis of output value.
Section 3 Analysis of the Financial Indicators of China's Non-prescription Drug Industry.
1. Industry profitability analysis.
2. Analysis of the solvency of the industry.
3. Analysis of industry operating capabilities.
Fourth, the analysis of industry development capabilities.
Chapter 10 2019-2023Analysis of the regional market status of China's OTC drug industry
Section 1 Analysis of the regional market size of China's non-prescription drug industry.
1. Factors affecting the regional market distribution of the OTC drug industry.
2. Regional market distribution of China's over-the-counter drug industry.
Section 2 Market Analysis of the OTC Drug Industry in East China.
1. Overview of East China.
2. Analysis of the economic environment in East China.
3. Market analysis of the over-the-counter drug industry in East China.
1) The market size of the OTC drug industry in East China.
2) The market status of the OTC drug industry in South China.
3) Market size of the OTC drug industry in East China**.
Section 3 Market Analysis in Central China.
1. Overview of Central China.
2. Analysis of the economic environment in central China.
3. Market analysis of the over-the-counter drug industry in central China.
1) The market size of the OTC drug industry in Central China.
2) The market status of the OTC drug industry in Central China.
3) The market size of the OTC drug industry in Central China**.
Section 4 Market Analysis in South China.
1. Overview of South China.
2. Analysis of the economic environment in South China.
3. Market analysis of the over-the-counter drug industry in South China.
1) The market size of the OTC drug industry in South China.
2) The market status of the OTC drug industry in South China.
3) Market size of the OTC drug industry in South China**.
Section 5 Market Analysis of Non-prescription Drug Industry in North China.
1. Overview of North China.
2. Analysis of the economic environment in North China.
3. Market analysis of the over-the-counter drug industry in North China.
1) The market size of the OTC drug industry in North China.
2) The market status of the OTC drug industry in North China.
3) The market size of the OTC drug industry in North China**.
Section 6 Market Analysis in Northeast China.
1. Overview of the Northeast region.
2. Analysis of the economic environment in Northeast China.
3. Market analysis of the over-the-counter drug industry in Northeast China.
1) The market size of the OTC drug industry in Northeast China.
2) The market status of the OTC drug industry in Northeast China.
3) The market size of the OTC drug industry in Northeast China**.
Section 7 Market Analysis in Southwest China.
1. Overview of the Southwest Region.
2. Analysis of the economic environment in southwest China.
3. Market analysis of the over-the-counter drug industry in southwest China.
1) The market size of the OTC drug industry in Southwest China.
2) The market status of the OTC drug industry in Southwest China.
3) Market size of the OTC drug industry in Southwest China**.
Section 8 Market Analysis in Northwest China.
1. Overview of the Northwest Territories.
2. Analysis of the economic environment in Northwest China.
3. Market analysis of the non-prescription drug industry in Northwest China.
1) The market size of the OTC drug industry in Northwest China.
2) The market status of the OTC drug industry in Northwest China.
3) Market size of the OTC drug industry in Northwest China**.
Chapter XICompany analysis of the OTC industry (adjusted for data updates).
Section 1 Enterprises.
First, the company profile.
Second, the main products.
3. Operation.
1. Main economic indicators.
2. Analysis of corporate profitability.
3. Analysis of corporate solvency.
4. Analysis of enterprise operation capabilities.
5. Analysis of enterprise growth ability.
Fourth, the company's advantages analysis.
Section 2: Enterprises.
First, the company profile.
Second, the main products.
3. Operation.
Fourth, the company's advantages and disadvantages analysis.
Section 3: Enterprises.
First, the company profile.
Second, the main products.
3. Operation.
Fourth, the company's advantages analysis.
Section 4 Enterprises.
First, the company profile.
Second, the main products.
3. Operation.
Fourth, the company's advantages analysis.
Section 5 Enterprises.
First, the company profile.
Second, the main products.
3. Operation.
Fourth, the company's advantages analysis.
Section 6 Enterprises.
First, the company profile.
Second, the main products.
3. Operation.
Fourth, the company's advantages analysis.
Section 7: Enterprises.
First, the company profile.
Second, the main products.
3. Operation.
Fourth, the company's advantages analysis.
Section 8 Enterprises.
First, the company profile.
Second, the main products.
3. Operation.
Fourth, the company's advantages analysis.
Section 9 Enterprises.
First, the company profile.
Second, the main products.
3. Operation.
Fourth, the company's advantages analysis.
Section 10 Enterprises.
First, the company profile.
Second, the main products.
3. Operation.
Fourth, the company's advantages analysis.
Chapter 12 2023-2030Analysis of the development prospects of China's over-the-counter drug industry
Section 1 Analysis of the future development prospects of China's non-prescription drug industry.
1. Analysis of the domestic investment environment of the over-the-counter drug industry.
2. Market opportunity analysis of China's OTC drug industry.
3. Investment growth rate in China's over-the-counter drug industry**.
Section 2 Future Development Trends of China's OTC Drug Industry**.
Section 3 Scale Development of China's OTC Drug Industry**.
1. The market size of China's over-the-counter drug industry**.
2. The growth rate of the market size of China's non-prescription drug industry**.
3. The output value of China's non-prescription drug industry**.
Fourth, the growth rate of the output value of China's non-prescription drug industry**.
5. Supply and demand of China's non-prescription drug industry**.
Section 4 Profit Trend of China's OTC Drug Industry**.
Chapter 13 2023-2030Analysis of entry barriers and investment risks in China's OTC drug industry
Section 1 Analysis of Barriers to Entry in China's OTC Drug Industry.
1. Analysis of financial barriers in the over-the-counter drug industry.
2. Analysis of technical barriers in the over-the-counter drug industry.
3. Analysis of talent barriers in the non-prescription drug industry.
4. Analysis of brand barriers in the over-the-counter drug industry.
5. Analysis of other barriers in the OTC drug industry.
Section 2 Risk Analysis of the OTC Drug Industry.
1. Macro environmental risks in the OTC drug industry.
2. Technical risks in the OTC drug industry.
3. Competition risks in the OTC drug industry.
4. Other risks in the non-prescription drug industry.
Section 3 Problems in China's OTC Drug Industry.
Section 4 Analysis of Problem Solving Strategies in China's OTC Drug Industry.
Chapter 14 2023-2030Research conclusions and investment recommendations for China's OTC drug industry
Section 1 A review of research on China's non-prescription drug industry in the world.
First, the investment value of the industry.
2. Industry risk assessment.
Section 2 Analysis of the entry strategy of China's non-prescription drug industry.
First, the target customer group of the industry.
Second, the selection of market segments.
Third, the choice of regional market.
Section 3 Analysis of marketing strategies in the OTC drug industry.
1. Product strategy of the OTC drug industry.
2. Pricing strategy of the OTC drug industry.
3. Channel strategy of the OTC drug industry.
Fourth, the over-the-counter drug industry strategy.
Section 4 Investment Advice from Analysts.