First, the management of licensed pharmacists
1. Licensed pharmacist qualification system
A. the connotation of licensed pharmacist system
B. Licensed Pharmacist Management Department
2 licensed pharmacist qualification examination and registration management
A. Licensed pharmacist qualification examination
B. Registration management of licensed pharmacists
3. Responsibilities of licensed pharmacists
The main responsibilities of licensed pharmacists
4. Continuing education of licensed pharmacists
A. Content and form requirements of continuing education
B. Continuing education credit management
Second, the professional ethics and service standards of licensed pharmacists
1. Professional Ethics of Licensed Pharmacists
Specific contents of professional ethics of licensed pharmacists in China
2. Pharmaceutical service specification for licensed pharmacists
Main contents of pharmaceutical service standards for licensed pharmacists in China
Three. Drug and drug safety management
1. Drugs and drug safety
A. Definition and quality characteristics of drugs
B. The importance of drug safety
2. Drug safety management
A. Characteristics and classification of drug safety risks
B. Main measures of drug safety risk management
3. Objectives and tasks of drug safety management in China.
A. Overall objectives
B. Planning indicators
C. Main tasks
D. protection
4. The state reforms and improves the policy of drug production, circulation and use.
Main contents of "Several Opinions on Further Reforming and Perfecting the Policy of Drug Production, Circulation and Use"
Chapter II Reform of Medical and Health System and National Essential Medicine System
First, deepen the reform of the medical and health system.
1. Basic principles and overall objectives
A. Basic principles
B. Overall objectives
2. Establish a national basic medical and health system.
The basic contents of public health service system, medical service system, medical security system and drug supply security system.
3. Improve the system and mechanism to ensure the effective and standardized operation of the medical and health system.
Improve the basic content of the system and mechanism.
4. Drug supply guarantee system
Main requirements and contents of establishing and perfecting drug supply security system
Second, the national essential drug system
1. The connotation of national essential drug system
A. Definition and main contents of essential drugs and national essential drug system
B. Objectives of implementing the essential drug system
C. Departments and functions of essential drug management
2. Management of National Essential Drugs List
A. Principles and scope of selection of essential drugs
B. Basis and cycle of adjustment of national essential drugs list
C. Composition of the National Essential Drugs List
3. Quality supervision and management of essential drugs
A. quality supervision institutions for essential drugs and their functions
B. Requirements for quality supervision of essential drugs
C. Provisions on drug traceability system
4. Procurement management of essential drugs
A. the general idea of centralized procurement of essential drugs
B. Main measures for centralized procurement of essential drugs
5. Reimbursement and compensation for essential drugs
A. Provisions for reimbursement of essential drugs
B. Compensation clauses for essential drugs
6. Management of the use of essential drugs
Main requirements for using essential drugs
Chapter III Drug Supervision and Administration System and Legal System
I. Drug supervision and administration institutions
1. Drug supervision and administration department
Responsibilities of national and local drug supervision and administration departments related to drug administration
2. Relevant departments of drug supervision and administration.
Responsibilities related to drug management, such as health and family planning department, Chinese medicine management department, macro-control department of development and reform, human resources and social security department, industrial and information management department, commercial administration department, customs, public security department, etc.
Two, drug supervision and management technical support institutions
Responsibilities of National Medical Products Administration Technical Title Organization
China Food and Drug Inspection and Research Institute, National Pharmacopoeia Committee, Drug Evaluation Center, Food and Drug Audit and Inspection Center, Drug Evaluation Center, National Traditional Chinese Medicine Variety Protection Evaluation Committee, Administrative Matters Acceptance Service and Complaint Reporting Center, Licensed Pharmacist Qualification Certification Center, and the duties of licensed pharmacists.
Three. Drug administration legislation
1. Basic legal knowledge
Characteristics, sources, effects and responsibilities of law.
2. Legal system and legal relationship of drug supervision
A. Legal system of drug administration
B. Legal relationship of drug administration
Four. Administrative legal system of drug supervision and management
1. Administrative license
A. Principles and matters of establishing and implementing administrative license
B. Application and acceptance of administrative license
C. Circumstances of revocation of administrative license
2. Administrative compulsion
A. Types of administrative coercive measures
B. Administrative law enforcement methods
3. Administrative punishment
Decisions and procedures of administrative punishment
4. Administrative reconsideration
Scope, application and time limit of administrative reconsideration
5. Administrative litigation
Scope, Prosecution and Acceptance of Administrative Litigation
Chapter IV Drug Development and Production Management
I. Drug development and registration management
1. Specification for drug development and quality management
A. stages and purposes of drug clinical trials
B. Basic requirements of quality management standards for non-clinical drug research and clinical drug trials
2. Reform of drug registration management and examination and approval system
A. Definition of drug registration and drug registration application
B. Drug registration agencies
C. Drug registration classification
D. Drug approval documents
E. Monitoring period of new drugs
F. Contents of the reform of drug and medical device review and approval
3. Drug reevaluation
Management of drug reevaluation
Second, drug production management
1. Pharmaceutical production license
A. Application and approval of pharmaceutical production license
B. Drug production license management
2. Regulations on Quality Management of Pharmaceutical Production
A. Basic requirements and implementation of A.GMP
B. principle of drug batch division
Basic requirements for C.c.GMP certification and inspection
3. Drug entrusted production management
A. Definition of entrusted production
B. restrictions on entrusted production varieties
4. Drug recall management
A. Definition of drug recall and drug safety hazards
B. Obligations of pharmaceutical producers, traders and users related to drug recall
C. Voluntary recall and ordered recall
D. Supervision and management of drug recall
Chapter V Administration of Drug Sales and Use
I. Drug management
1. Drug business license
A. Application and approval of drug trading (wholesale and retail) license
B. Drug business license management
2. Good quality management practices of pharmaceutical enterprises.
A. Quality management of drug wholesale
B. Quality management of drug retail
Basic contents and requirements of C.c.GSP certification and inspection
3. Drug purchase and sale management
First, it is forbidden to operate without a license, sell counterfeit and inferior drugs and other business activities that are not allowed.
B. Rules and requirements to be observed in the purchase and sale of drugs
C. management of purchasing and sales personnel
D. Management of purchase and sale records and sales vouchers
4. Internet drug management
A qualification, application, approval, supervision and management of drug information service on the internet
B. Types of Internet drug trading services
C. Subject qualification, application, approval, supervision and management of Internet drug trading services
Second, drug use management
1. Pharmaceutical Affairs Management in Medical Institutions
A. The main contents of pharmaceutical affairs management in medical institutions
B. Drug regulatory agencies and pharmaceutical departments
2. Drug procurement and inventory management
A. Drug procurement regulations
B. Drug purchase inspection and acceptance system and purchase (acceptance) record management
C. Provisions on the management, storage and maintenance of drug stocks
3. Prescription and deployment management
A. Prescription and prescription management
B. Prescription issuance, dispensing and review
C. Prescription review system
D. provisions prohibiting prescription dispensing.
E. Prescription shelf life and destruction procedures
F. Provisions for the registration of special books on narcotic drugs and psychotropic substances
G. Legal liability for violating prescription management and dispensing requirements
4. Preparation management of medical institutions
A. Establishment and licensing management of medical institutions
B. Registration and variety range of self-made preparations in medical institutions
Format of approval document and approval number of preparation registration in medical institutions
D. Preparation and use of preparations in medical institutions
5. Drug clinical application management
A. Principles of rational drug use
B. Specific provisions on the management of clinical application of drugs
C. Classified management of antibacterial drugs
D. Purchase, use and regular evaluation of antibacterial drugs
Prescription right, qualification granting, supervision and management of antibacterial drugs
F clinical application monitoring, bacterial resistance monitoring and rational use of antibacterial drugs
G. Abnormal clinical application of antibacterial drugs and its treatment
Three, drug classification management
1. Establishment of drug classification management system
A. The purpose of drug classification management
B. Responsibilities of licensed pharmacists and regulatory authorities in classified management
2. Implementation of classified management of over-the-counter drugs and prescription drugs
A. Definition and basis of over-the-counter drugs, prescription drugs and "double-span" drugs
B. Classification of OTC drugs and management of patent labels
C. Management requirements for over-the-counter drugs
D. Management requirements for prescription drugs
E. Management requirements for "double-span" drugs
3. OTC drug list selection and conversion evaluation
A. Selection, approval and publication of the catalogue and catalogue of over-the-counter drugs
B. evaluation of conversion between prescription drugs and over-the-counter drugs
4. Circulation management of prescription drugs and over-the-counter drugs
A. Requirements for selling prescription drugs and over-the-counter drugs by production and wholesale enterprises
B. Requirements for retail pharmacies to sell prescription drugs and over-the-counter drugs
C. Types of drugs that retail pharmacies are not allowed to operate
D types of drugs that retail pharmacies must sell by prescription.
Four, medical security drug management
1. Basic medical insurance system
A. Composition of basic medical insurance system in China
B coverage, overall planning level and payment method, overall planning fund and individual account, and fixed-point management of the basic medical insurance for urban workers.
Coverage, financing level, payment and subsidy, fee payment and fixed-point management of basic medical insurance for urban residents
Coverage, overall level and financing standard of new rural cooperative medical system
2. The basic medical insurance drug list
A. Principles and conditions for determining the medical insurance drug list
B drugs that are not included in the basic medical insurance coverage.
C. Classification, formulation and adjustment of medical insurance drug list
D. payment principles for the use of medical insurance drugs
E. Management requirements for the use of medical insurance drug list by designated medical institutions and retail pharmacies
3. Agreement management of designated medical institutions for basic medical insurance
Specific policies and requirements for agreement management of pharmaceutical institutions
Five, adverse drug reaction reporting and monitoring management
1. Definition and classification of adverse drug reactions
A. definition and distinction of adverse drug reactions and related terms
B. Classification of adverse drug reactions
2. Adverse drug reaction report and disposal
A. Supervision subject, scope and subject of adverse drug reaction reports
B. Reporting and handling of adverse drug reactions
C. Reporting and handling of adverse events in drug groups
D. reporting and handling of serious adverse drug reactions abroad
E. Regular safety update report
3. Monitoring of key drugs
Scope and requirements of key drug monitoring
4. Evaluation and control of adverse drug reactions
A. Evaluation and control of adverse drug reactions by pharmaceutical enterprises
B. Evaluation and control of adverse drug reactions by adverse drug reaction monitoring institutions
Chapter VI Administration of Traditional Chinese Medicine
First, Chinese medicine and its innovation and development
1. Classification of traditional Chinese medicine
Chinese herbal medicines, Chinese herbal pieces, Chinese patent medicines
2. Construction of innovative system of traditional Chinese medicine
Main contents of the outline of innovative development plan of traditional Chinese medicine
3. Chinese medicine legislation
A. Management system and development policy conforming to the characteristics of traditional Chinese medicine
B provisions of the Chinese medicine law on the protection, development and inheritance of Chinese medicine
Second, the management of Chinese herbal medicines
1. Provisions on the production, management and use of Chinese herbal medicines
A. Chinese herbal medicine planting and breeding management
B. Primary processing management of Chinese herbal medicines
C. Management requirements for self-cultivation, self-support and self-use of Chinese herbal medicines
2. Chinese herbal medicine production quality management norms
Basic requirements and implementation of GAP
3. Professional market management
A. conditions for entering the specialized market of Chinese herbal medicines to operate Chinese herbal medicines.
B. Management measures for the specialized market of Chinese herbal medicines
4. Provisions on imported medicinal materials
A. Application and approval of imported medicinal materials
B. approved drugs for imported medicinal materials. All these can be found on the internet. Line. www.med 126.com
5. Protection of wild medicinal resources
A. classification of national key protected wild medicinal materials
B. Management requirements for hunting and catching national key protected wild medicinal materials
C. export management of wild medicinal materials under special state protection
D. List of national key protected wild medicinal materials
Third, the management of Chinese herbal pieces
1. Production and management
A. supervision of the production and operation of Chinese herbal pieces
B. Provisions on the Administration of Fixed-point Production of Toxic Chinese Herbal Pieces
2. Management of Chinese herbal pieces in medical institutions
Management requirements of traditional Chinese medicine decoction pieces
Four, the management of Chinese patent medicines and traditional Chinese medicine preparations in medical institutions
Traditional Chinese medicine variety protection
A. the purpose and significance of variety protection of traditional Chinese medicine
B. the scope of application of the regulations on the protection of varieties of traditional Chinese medicine
C. Scope and classification of protected varieties of traditional Chinese medicine
D. Protection measures for protected varieties of traditional Chinese medicine
E. Requirements for preparation and use of traditional Chinese medicine preparations
F. Requirements for commissioned production of traditional Chinese medicine preparations by medical institutions
Chapter VII Administration of Specially Administered Drugs
I. Management of Narcotic Drugs and Psychotropic Substances
1. Definition and management departments of narcotic drugs and psychotropic substances
A. Definition and distinctive signs of narcotic drugs and psychotropic substances
B. Management departments and responsibilities of narcotic drugs and psychotropic substances
2. List of narcotic drugs and psychotropic substances
Varieties of narcotic drugs and psychotropic drugs produced and used in China
3. Production of narcotic drugs and psychotropic substances
A. Total output control
B. fixed-point production and channel restrictions
4. Management of narcotic drugs and psychotropic substances
A. Necessary conditions for fixed-point operation of enterprises
B. Examination and approval of fixed-point business qualifications
C. procurement, sales and retail management
5. Use of narcotic drugs and psychotropic substances
A. Use approval and seal card management
B. Prescription qualification and prescription management
C. Loan and reserve clauses
6. Storage and transportation of narcotic drugs and psychotropic substances
A. Storage of Class I narcotic drugs and psychotropic substances
B. Storage of psychotropic substances in category II
C. Transportation and mailing management
D. Information management requirements for drug transportation between enterprises
Second, the management of toxic drugs for medical use
1. Definition and types of toxic drugs for medical use
A. Definition and special marks of toxic drugs for medical use
B. Varieties of toxic drugs for medical use
2. Production and management
A. Production and operation qualification management
B. Production management of toxic drugs
C. storage and transportation requirements
3. Use management
A. Provisions on supply allocation of medical institutions and retail pharmacies
B. Provisions on the allocation of toxic drugs required by scientific research and teaching units
Three. Management of precursor chemicals for drugs
1. Definition and classification of pharmaceutical precursor chemicals
A. Definition of drug precursor chemicals
B. Types and classification of pharmaceutical precursor chemicals
2. Management of the circulation and use of pharmaceutical precursor chemicals
Requirements for the purchase and sale of pharmaceutical precursor chemicals
Four, the management of compound preparations containing special drugs
1. Management of compound preparations containing narcotic drugs and psychotropic drugs
A. Variety range of compound preparations containing special drugs
B. Management of compound preparations containing special drugs
2. Management of compound preparations containing ephedrine
A. Business conduct management
B. Sales management
Verb (abbreviation for verb) Doping management
Definition and classification of stimulants
A. Definition of stimulants
B. Catalogue and classification of stimulants
2. Doping sales and use management
A. management of labels and instructions for drugs containing stimulants
B. Management of sales and use of protein assimilation agents and peptide hormones
Immutable Verb Vaccine Management
1. vaccine circulation management
A. Definition and classification
B. Reform of vaccine circulation mode and requirements for procurement, supply and distribution
C. Whole-course traceability system of vaccine and whole-course cold chain storage and transportation management system
2. Supervision and management of vaccines
Measures to deal with fake and shoddy vaccines with suspicious quality.
Chapter VIII Drug Standards and Drug Quality Supervision and Inspection
I. Management of Drug Standards
Drug standards and national drug standards
A. Standard classification and efficacy of drugs
B. definition and classification of national drug standards
C. Principles for setting drug standards
Second, drug instructions and label management
1. Basic requirements for drug instructions and labels
A. Definition and function of drug instructions and labels
B. Requirements for printing and writing of drug instructions and labels
C. Labeling and use requirements of drug names and registered trademarks
D. Identification of drugs for external use
2. Provisions on the administration of drug instructions
A. requirements for writing and revising instructions
B. Key points of compiling drug instructions
C. Basic contents of format and writing requirements of drug instructions
3. Provisions on the administration of drug labels
A. Classification and labeling contents of drug labels
B. Provisions on the labeling of the same drug variety
C. Provisions on the expiry date of drugs on drug labels
Three, drug quality supervision and inspection and drug quality announcement
1. Drug quality supervision and inspection institutions
A. Definition and nature of drug quality supervision and inspection
B. Drug quality supervision and inspection institutions
2 types of drug quality supervision and inspection
Spot check inspection, registration inspection, designated inspection and reinspection.
3. Drug quality announcement
A. Definition and function of drug quality announcement
B. Publishing rights and contents
Chapter IX Drug Advertising Management and Consumer Rights Protection
First, drug advertising management
1. Approval of drug advertisements
A. Definition of drug advertisement
B. Application, examination and publication of drug advertisements
2. Contents of drug advertisements
Content requirements of drug advertisements
3. Drug advertisement inspection
Contents and methods of drug advertisement inspection
4. Legal liability
Legal liability for violating drug advertisements
Two. anti- unfair competition law
Unfair competition behavior
A. definition of anti-unfair competition
B identification of confusion, competition restriction, commercial bribery, false propaganda, infringement of trade secrets, low-price dumping, unfair sales with prizes, and defamation of goodwill.
Third, protect consumers' rights and interests
1. Application of law
Definition of consumer and scope of application of consumer protection law
2. Consumer rights and interests
Right to safety, right to know, right to choose independently, right to fair trade, right to compensation, right to association, right to acquire knowledge, right to be respected, right to supervise and criticize.
3. Obligations of the operator
Obligations to be performed by operators
4. Protection of consumer rights and interests
Measures to protect consumers' rights and interests
5. Settlement of disputes
A. methods of dispute settlement
B. Special rules for the settlement of disputes
Chapter X Legal Liability for Drug Safety
First, the legal responsibility and characteristics of drug safety
Definition and types of legal liability for drug safety
A. Definition of legal liability for drug safety
B. Types of legal liability for drug safety
Two, the legal responsibility for the production and sale of counterfeit drugs and inferior drugs
1. Legal responsibility for producing and selling counterfeit drugs
A. Identification of counterfeit drugs
B. Administrative responsibility for producing and selling counterfeit drugs
C. Criminal responsibility for producing and selling counterfeit drugs
2. Legal responsibility for producing and selling inferior drugs
A. Identification of inferior drugs
B. Administrative responsibility for producing and selling inferior drugs
C. Criminal responsibility for producing and selling inferior drugs
Three, in violation of the provisions of the drug supervision and management of legal responsibility
1. Legal liability of unlicensed production and operation
A. Legal liability for producing and selling drugs without a license
B. Legal liability for purchasing drugs from unlicensed production and operation enterprises
2. Legal liability for violating drug quality management norms
The legal responsibility for failing to implement the good manufacturing practice and the quality management standard of drug business in accordance with the regulations.
3. Legal responsibilities related to licenses and approval documents
Legal liability for forging, altering, buying, selling, renting or lending licenses or drug approval documents.
B. Legal liability for defrauding licenses or approval documents
4. Legal liability of drug commercial bribery
Legal liability for secretly giving or accepting kickbacks or other benefits in drug purchase and sale activities
B legal liability for accepting property or other benefits in drug purchase and sale activities
5. Legal liability for violating the provisions on reporting and monitoring of adverse drug reactions.
Legal liability of drug production, marketing and use units in violation of the provisions on reporting and monitoring of adverse drug reactions.
6. Legal liability for violating the regulations on drug recall management
The legal responsibility of the drug production, marketing and use unit for failing to fulfill the relevant obligations of recall.
7. Legal liability for other acts in violation of drug supervision and administration regulations.
A. Legal liability for violating the registration and filing management system of imported drugs
B. Legal liability of medical institutions to sell preparations to the market
C. Legal liabilities of pharmaceutical trading enterprises in violation of the requirements of purchase and sale records and the provisions of drug sales behavior
D. legal liability for violating drug labeling regulations
Four, in violation of the provisions of the special management of drugs management legal responsibility.
1. Legal liability for violating the regulations on the administration of narcotic drugs and psychotropic substances
A. Legal responsibilities of designated production enterprises
B. Legal liability for running a business
C. Legal responsibilities of medical institutions
D. Legal responsibilities of medical practitioners
E. Legal responsibilities of prescription dispensers and auditors
F. Legal responsibilities of drug regulatory authorities and health authorities
2. Legal liability for violating the regulations on the administration of pharmaceutical precursor chemicals.
A. Legal responsibilities for smuggling and illegal trading of ephedrine compound preparations.
B. Legal liability for violating the Regulations on the Administration of Drugs and Precursor Chemicals
3. Legal liability for violating the provisions on the administration of toxic drugs
Legal liability for unauthorized production, purchase and operation of toxic drugs
Five, in violation of the relevant provisions of the law of traditional Chinese medicine legal responsibility
1. Legal responsibility for violating the provisions on the record management of holding Chinese medicine clinics, processing Chinese herbal pieces and entrusting the preparation of Chinese medicine preparations.
A legal liability for filing without filing, or providing false materials when filing.
B. Punishment for failing to record the traditional Chinese medicine preparation according to the regulations or preparing the traditional Chinese medicine preparation according to the requirements specified in the filing materials.
2. The legal responsibility of using highly toxic and highly toxic pesticides in the process of planting Chinese herbal medicines.
Legal liability for illegal use of highly toxic and toxic pesticides
Chapter II XI Management of Medical Devices, Health Food and Cosmetics
I. Management of Medical Devices
1. Basic requirements of medical device management
A. definition of medical device medicine. All of them. Open. Line. Provide. www.med 126.com
B. Classification of medical devices
C. Product registration and filing management
D. Format of medical device registration certificate and filing certificate
E. Management of medical device instructions and labels
2. Medical device operation and use management
A. Classified management of medical device business
B. Management of medical device business license
C. Basic requirements of operational quality management norms
D. Use and management of medical devices
3. Handling of medical device adverse events and problem product phone calls
A. Monitoring of medical device adverse events
B. Re-evaluation and result processing of medical devices
C. Medical device recall management
Two, health food management, special medical use formula food and infant formula food management
Basic requirements of health food management
A. Definition of health food
B. Characteristics of health food
C. Management of health food approval number
Third, cosmetics management
Basic requirements of cosmetics management
A. Definition and classification of cosmetics
B. Management of cosmetics production license and approval number