Chapter 1 Licensed Pharmacists and Drug Safety
1. Licensed Pharmacist Management
1. Licensed Pharmacist Qualification System
a. Licensed Pharmacist The connotation of the 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
Main responsibilities of licensed pharmacists
4. Continuing education of licensed pharmacists
a. Continuing education content and format requirements
b. Continuing education credit management
2. Professional ethics and service standards for practicing pharmacists
1. Practice Pharmacist professional ethics
The specific contents of the professional ethics code for practicing pharmacists in my country
2. Pharmaceutical service standards for practicing pharmacists
The main contents of the pharmaceutical service standards for practicing pharmacists in my country
III. Drugs 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 for drug safety risk management
3. Goals and tasks of drug safety management in my country
a. Overall goals
b. Planning indicators
c. Main tasks
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d. Safeguard measures
4. National reform and improvement of drug production, distribution and use policies
The main contents of "Several Opinions on Further Reform and Improvement of Drug Production, Distribution and Use Policies"
Chapter 2 Medical and Health System Reform and National Essential Drug System
1. Deepening the Medical and Health System Reform
1. Basic Principles and Overall Goals
a. Basic principles
b. Overall goals
2. Establish a national basic medical and health system
Public health service system, medical The basic content of the service system, medical security system, and drug supply security system
3. Improve the institutional mechanism to ensure the effective and standardized operation of the medical and health system
Improve the basic content of the institutional mechanism
4. Drug supply guarantee system
The main requirements and contents of establishing and improving the drug supply guarantee system
2. National essential drug system
1. The connotation of the national essential medicine system
a. The definition and main content of essential medicines and the national essential medicine system
b. The goals of implementing the essential medicine system
c .Essential medicine management departments and functions
2. National essential medicine list management
a. Essential medicine selection principles and scope
b. Adjustment of the national essential medicine list Basis and cycle
c. Composition of the National Essential Medicines List
3. Quality supervision and management of essential medicines
a. Essential medicines quality supervision agencies and functions
b. Quality supervision requirements for essential drugs
c. Regulations on drug traceability systems
4. Essential drug procurement management
a. Essential drugs The overall idea of ??centralized procurement
b. Main measures for centralized procurement of essential drugs
5. Reimbursement and compensation of essential drugs
a. Reimbursement regulations for essential drugs
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b. Compensation regulations for essential drugs
6. Management of the use of essential drugs
Main requirements for the use of essential drugs
Chapter 3 Drug Supervision and Management System and legal system
1. Drug regulatory agencies
1. Drugs
Drug Supervision and Administration Department
Responsibilities of national and local drug supervision and administration departments related to drug management
2. Departments related to drug management
Health and Family Planning Department, Central Government Pharmaceutical management departments, development and reform macro-control departments, human resources and social security departments, industrial and commercial administration departments, industrial and information management departments, business management departments, customs, public security departments and other responsibilities related to drug management
2. Technical Support Institutions for Drug Supervision and Administration
Responsibilities of National Technical Institutions for Drug Supervision and Administration
China Institute for Food and Drug Control, National Pharmacopoeia Commission, Drug Evaluation Center, Food and Drug Responsibilities of the Review and Inspection Center, the Drug Evaluation Center, the National Traditional Chinese Medicine Variety Protection Review Committee, the Administrative Matters Acceptance Service and Complaint Reporting Center, and the Licensed Pharmacist Qualification Certification Center related to the practice of licensed pharmacists
3. Drug Management Legislation
1. Basic knowledge of law
Characteristics of law, legal origin, legal effect, legal liability
2. Drug management legal system and legal relationships
a. Drug management legal system
b. Drug management legal relationship
IV. Drug supervision and management administrative legal system
1. Administrative licensing
a. Principles and matters for establishing and implementing administrative licensing
b. Administrative licensing application and acceptance
c. Situations for revoking administrative licensing
2. Administrative enforcement
a. Types of administrative enforcement measures
b. Methods of administrative enforcement
3. Administrative penalties
Decisions and procedures for administrative penalties
4. Administrative reconsideration
Scope, application and deadline of administrative reconsideration
5. Administrative litigation
Scope, prosecution and acceptance of administrative litigation
Chapter 4 Drug R&D and Production Management
1. Drug R&D and Registration Management
1 .Drug development and quality management practices
a. Stages and purposes of drug clinical trials
b.Basic requirements for drug non-clinical research quality management practices and drug clinical trial quality management practices
2. Reform of drug registration management and review and approval system
a. Definition of drug registration and drug registration application
b. Drug registration management agency
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c. Drug registration classification
d. Drug approval documents
e. New drug monitoring period
f. Drug and medical device review and approval reform Content
3. Drug re-evaluation
Management of drug re-evaluation
2. Drug production management
1. Drug production license
a. Application and approval of drug production license
b. Drug production license management
2. Drug production quality management regulations
a.Basic requirements and implementation of GMP
b.Principles of drug batch division
c.Basic requirements for GMP certification and inspection
3.Consigned production of drugs Management
a. Definition of commissioned production
b. Restrictions on varieties of commissioned production
4. Drug recall management
a. Drug recall and the definition of drug safety hazards
b. Obligations of drug production and operating enterprises and user units regarding drug recalls
c. Voluntary recalls and ordered recalls
d .Supervision and management of drug recalls
Chapter 5 Drug business and use management
1. Drug business management
1. Drug business license
a. Application and approval of pharmaceutical business (wholesale, retail) license
b. Management of pharmaceutical business license
2. Drug business quality
Management Standards
a. Quality Management of Drug Wholesale
b. Quality Management of Drug Retail
c. Basic Content and Requirements of GSP Certification and Inspection
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3. Management of drug purchase and sale
a. Prohibition of operating without a license, sale of counterfeit and substandard drugs, and other prohibited business activities
b. Rules that should be followed when purchasing and selling drugs Regulations and Requirements
c. Management of purchase and sales personnel
d. Management of purchase and sale records and sales vouchers
4. Internet drug business management
a. Qualification, application and approval, supervision and management of Internet drug information services
b. Types of Internet drug trading services
c. Qualifications of entities engaged in Internet drug trading services , Application and approval, supervision and management
2. Drug use management
1. Pharmaceutical management of medical institutions
a. Main contents of pharmaceutical management of medical institutions
b. Pharmaceutical management organization and pharmaceutical department
2. Drug purchase and inventory management
a. Drug purchase regulations
b. Drug purchase inspection and acceptance system and purchase (acceptance) record management
c. Drug inventory management and storage and maintenance regulations
3. Prescription and dispensing management
a. Prescription and prescription management
b. Prescription issuance, dispensing and review
c. Prescription evaluation system
d. No one is allowed to engage in prescription dispensing work Regulations
e. Prescription retention period and destruction procedures
f. Regulations on the registration of special registers of narcotic drugs and psychotropic drugs
g. Violation of prescription management and dispensing requirements Legal responsibilities
4. Preparation management of medical institutions
a. Preparation and license management of medical institutions
b. Registration and variety scope of self-prepared preparations of medical institutions
c. Medical institution preparation registration approval document and approval number format
d. Dispensing and use of medical institution preparations
5. Drug clinical application management
a. Principles of rational drug use
b. Specific regulations on clinical application management of drugs
c. Hierarchical management of antibacterial drugs
d. Antibacterial drugs Purchase, use and regular evaluation
e. Antimicrobial drug prescription rights, dispensing qualification grant and supervision management
f. Antimicrobial drug clinical application monitoring, bacterial resistance monitoring and rational use
g. Abnormalities in the clinical application of antibacterial drugs and their treatment
3. Drug classification management
1. Establishment of a drug classification management system
a. The purpose of classified management of drugs
b. The responsibilities of licensed pharmacists and regulatory authorities in classified management
2. Implementation of classified management of non-prescription drugs and prescription drugs
a. Definition and basis of over-the-counter drugs, prescription drugs, and "double-span" drugs
b. Classification of over-the-counter drugs and management of proprietary labels
c. Management requirements for over-the-counter drugs
d. Management requirements for prescription drugs
e. Management requirements for “double-span” drugs
3. Selection and conversion evaluation of over-the-counter drug catalog
a .Selection, approval and release of over-the-counter drug catalogs
b.Conversion evaluation of prescription and over-the-counter drugs
4.Circulation management of prescription and over-the-counter drugs
a. Requirements for production and wholesale enterprises to sell prescription and over-the-counter drugs
b. Requirements for retail pharmacies to sell prescription 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 with prescriptions
IV. Medical insurance medication management
1. Basic medical insurance system
a.
The composition of my country's basic medical insurance system
b. The coverage, overall planning level and payment methods, overall planning funds and personal accounts, and designated management of urban employee basic medical insurance
c. Urban residents The coverage, financing level, payment and subsidy, fee payment, and designated management of basic medical insurance
d. The coverage, overall planning level, and financing standards of new rural cooperative medical care
2 .Basic medical insurance drug catalog
a. Principles and conditions for determining the medical insurance drug catalog
b. Drugs that are not allowed to be included in the scope of basic medical insurance
c. Classification, formulation and adjustment of the medical insurance drug catalog
d. Payment principles for the use of medical insurance drugs
e. Management requirements for the use of the medical insurance drug catalog by designated medical institutions and retail pharmacies
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3. Basic medical insurance designated medical institution agreement management
Specific policies and requirements for medical institution agreement management
5. 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. Reporting and handling of adverse drug reactions
a. Adverse drug reaction reporting entities, reporting scope, and supervision entities
b. Reporting and handling of individual adverse drug reactions
c. Reporting and handling of adverse drug events in drug groups
d. Reporting and handling of serious adverse drug reactions occurring overseas
e. Regular safety update reports
3. Key drug monitoring
Scope and requirements of key drug monitoring
4. Evaluation and control of adverse drug reactions
a. Evaluation and control of adverse drug reactions by drug manufacturers
b. Evaluation and control of adverse drug reactions by adverse drug reaction monitoring agencies
Chapter 6 Management of Traditional Chinese Medicines
1. Traditional Chinese Medicine and Traditional Chinese Medicine Innovation and Development
1. Classification of Traditional Chinese Medicine
Traditional Chinese Medicine, Traditional Chinese Medicine Pieces, and Chinese Patent Medicines
2. Construction of Traditional Chinese Medicine Innovation System
The main contents of the Outline of the Traditional Chinese Medicine Innovation and Development Plan
3. Traditional Chinese Medicine Legislation
a. Management systems and development policies that are consistent with the characteristics of traditional Chinese medicine
b. The "Traditional Chinese Medicine Law" stipulates the protection, development and inheritance of traditional Chinese medicine
2. Management of traditional Chinese medicinal materials
1. Production, operation and use of traditional Chinese medicinal materials Regulations
a. Management of planting and breeding of Chinese medicinal materials
b. Management of primary processing of Chinese medicinal materials in origin
c. Management of self-growing, self-processing and self-use of Chinese medicinal materials Requirements
2. Good Manufacturing Practices for Traditional Chinese Medicinal Materials
Basic requirements and implementation of GAP
3. Professional market management
a. Conditions that those who enter the professional market for Chinese medicinal materials and operate Chinese medicinal materials should meet
b. Measures for the management of the professional market for Chinese medicinal materials
4. Regulations on imported medicinal materials
a. Application and approval of imported medicinal materials
b. Medical approval documents for imported medicinal materials are fully available online at www.med126.com
5. Protection of wild medicinal resources
a. Classification of national key protected wild medicinal species
b. National key protected wild medicinal materials hunting management requirements
c. National key protected wild medicinal materials export management
p>d. List of nationally protected wild medicinal materials
3. Management of traditional Chinese medicine pieces
1. Production and business management
a. Traditional Chinese medicine pieces Supervision of production and business operations
b. Provisions on designated production and operation management of toxic traditional Chinese medicine pieces
2. Management of traditional Chinese medicine pieces in medical institutions
Management
Management requirements for traditional Chinese medicine preparations
IV. Management of Chinese patent medicines and traditional Chinese medicine preparations in medical institutions
Protection of traditional Chinese medicine varieties
a. Traditional Chinese medicine varieties The purpose and significance of protection
b. The scope of application of the "Regulations on the Protection of Traditional Chinese Medicine Variety"
c. The scope and classification of protected varieties of traditional Chinese medicine
d. Traditional Chinese Medicine Protection measures for protected varieties
e. Requirements for the preparation and use of traditional Chinese medicine preparations
f. Requirements for the commissioned production of traditional Chinese medicine preparations in medical institutions
Chapter 7 Specially managed drugs Management
1. Management of narcotic drugs and psychotropic drugs
1. Definition and management department of narcotic drugs and psychotropic drugs
a. Narcotic drugs and psychotropic drugs Definition and proprietary signs
b. Management departments and responsibilities of narcotic drugs and psychotropic drugs
2. Catalog of narcotic drugs and psychotropic drugs
my country’s production and Varieties of narcotic drugs and psychotropic drugs used
3. Production of narcotic drugs and psychotropic drugs
a. Total production volume control
b. Designated production and channel restrictions
4. Operation of narcotic drugs and psychotropic drugs
a. Necessary conditions for designated operating enterprises
b. Approval of designated operating qualifications
c. Purchase, sale and retail management
5. Use of narcotic drugs and psychotropic drugs
a. Usage approval and seal card management
b. Prescription qualification and prescription management
c. Borrowing and preparation regulations
6. Storage and transportation of narcotic drugs and psychotropic drugs
a. Storage of narcotic drugs and first-category psychotropic drugs
b. Storage of Class II psychotropic drugs
c. Transportation and mailing management
d. Inter-enterprise drug transportation information management requirements
2. Management of toxic drugs for medical use
1. Definition and varieties of toxic drugs for medical use
a. Definition and special signs of toxic drugs for medical use
b. Types of toxic drugs for medical use
2. Production and business management
a. Production and business qualification management
b. Production management of toxic drugs
c. Storage and transportation requirements
3. Usage management
a. Supply and dispensing regulations for medical institutions and retail pharmacies
b. Regulations on the preparation of toxic drugs required by scientific research and teaching units
3. Management of pharmaceutical precursor chemicals
1. Definition and classification of pharmaceutical precursor chemicals
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a. Definition of pharmaceutical precursor chemicals
b. Types and classifications of pharmaceutical precursor chemicals
2. Pharmaceutical precursor chemicals Management of circulation and use
Purchase and sale requirements for pharmaceutical precursor chemicals
IV. Management of compound preparations containing special drugs
1. Containing narcotic drugs , Management of compound preparations of psychotropic drugs
a. Scope of varieties of compound preparations containing special drugs
b. Operation and management of compound preparations containing special drugs
2. Management of compound preparations containing ephedrine
a. Business behavior management
b. Sales management
V. Management of stimulants
1. Definition and classification of stimulants
a. Definition of stimulants
b. Catalog and classification of stimulants
2. Management of stimulant sales and use
a. Management of labels and instructions for drugs containing stimulants
b. Management of sales and use of anabolic preparations and peptide hormones
6. Management of vaccines
1. Vaccine circulation management
a. Definition and classification
b. Vaccine circulation method
formal reform and procurement, supply, and distribution requirements
c. Full vaccine traceability system and full cold chain storage and transportation management system
2. Vaccine supervision and management
Measures for handling vaccines that are found to be fake or of questionable quality
Chapter 8 Drug Standards and Drug Quality Supervision and Inspection
1. Drug Standard Management
Drug Standards and National drug standards
a. Classification and effectiveness of drug standards
b. Definition and categories of national drug standards
c. Principles for the formulation of drug standards
II. Drug Instructions and Label Management
1. Basic requirements for drug instructions and labels
a. The definition and function of drug instructions and labels
b .Requirements for drug instructions, label printing and text expression
c. Labeling and use requirements of drug names and registered trademarks
d. Labeling of external drugs
2. Regulations on the management of drug instructions
a. Requirements for writing and modifying instructions
b. Key points for writing drug instructions
c. Format and writing requirements for drug instructions Basic content
3. Drug label management regulations
a. Classification and labeling content of drug labels
b. Regulations on drug labels of the same variety
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c. Regulations on the validity period of drugs on drug labels
3. Drug quality supervision and inspection and drug quality announcement
1. Drug quality supervision and inspection and inspection agencies
a. The 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 inspection, registration inspection, designated inspection and re-inspection
3. Drug quality announcement
a. Definition and function of drug quality announcement
b. Release authority and Published Content
Chapter 9 Drug Advertising Management and Consumer Rights Protection
1. Drug Advertising Management
1. Approval of Drug Advertising
a. Definition of drug advertising
b. Application, review and release of drug advertising
2. Content of drug advertising
Requirements for drug advertising content
3. Inspection of drug advertisements
Contents and methods of inspection of drug advertisements
4. Legal liability
Legal liability for violations of drug advertisements
2. Anti-unfair competition law
Unfair competition behavior
a. Definition of anti-unfair competition
b. Confusion Behaviors, restrictive competition, commercial bribery, false publicity, infringement of trade secrets, low-price dumping, unfair sales with prizes, and defamation of goodwill
3. Protection of consumer rights
p>1. Applicable law
The definition of consumers and the scope of application of the Consumer Rights Protection Law
2. The rights and interests of consumers
Safety The right to protection, the right to know the truth, the right to choose independently, the right to fair trade, the right to compensation, the right to association, the right to acquire knowledge, the right to be respected, the right to supervise and criticize
3. Obligations of operators
Obligations that operators should fulfill
4. Protection of consumer rights and interests
Measures to protect consumer rights and interests
5. Resolution of disputes
p>a. Ways to resolve disputes
b. Special rules for dispute resolution
Chapter 10 Legal Responsibilities for Drug Safety
1. Drug Safety Legal responsibilities and characteristics
Definition and types of legal responsibilities for drug safety
a. Definition of legal responsibilities for drug safety
b. Types of legal responsibilities for drug safety
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2. Production and sales of counterfeit and substandard drugs
Legal liability
1. Legal liability for producing and selling counterfeit drugs
a. Identification of counterfeit drugs
b. Administrative liability for producing and selling counterfeit drugs
c. Criminal liability for producing and selling counterfeit drugs
2. Legal liability for producing and selling inferior drugs
a. Identification of inferior drugs
b. Administrative liability for the production and sale of inferior drugs
c. Criminal liability for the production and sale of inferior drugs
3. Legal liability for violation of drug supervision and administration regulations
p>1. Legal liability related to unlicensed production and operation
a. Legal liability for unlicensed production and operation of drugs
b. From unlicensed production and operation enterprises Legal liability for purchased drugs
2. Legal liability for violation of drug quality management regulations
Failure to implement the "Good Manufacturing Practice for Drugs" and "Good Manufacturing Practice for Drugs" as required Legal liability
3. Legal liability related to licenses and approval documents
a. Legal liability for forging, altering, buying and selling, renting, or lending licenses or drug approval documents
b. Legal liability for fraudulently obtaining licenses or approval documents
4. Legal liability for drug commercial bribery
a. Secretly giving money during drug purchase and sale activities , Legal liability for accepting kickbacks or other benefits
b. Legal liability for accepting property or other benefits during drug purchase and sales activities
5. Legal liability for violating adverse drug reaction reporting and monitoring regulations
Legal liability of drug production, distribution and user units that violate adverse drug reaction reporting and monitoring regulations
6. Legal liability of violation of drug recall management regulations
Drugs The legal liability of production, operation and user units for failing to perform their obligations related to recalls
7. Legal liability for other violations of drug supervision and management regulations
a. Violations of the imported drug registration and filing management system Legal liability
b. Legal liability of medical institutions for selling preparations to the market
c. Legal liability of drug dealers for violating purchase and sales record requirements and drug sales behavior regulations
d. Legal liability for violating drug labeling management regulations
IV. Legal liability for violating special management drug management regulations
1. Legal liability for violating narcotic drugs and psychotropic drugs management regulations
a. Legal liability of designated production enterprises
b. Legal liability of operating enterprises
c. Legal liability of medical institutions
d .Legal responsibilities of practicing physicians
e.Legal responsibilities of prescription dispensers and checkers
f.Legal responsibilities of drug regulatory authorities and health authorities
2. Legal liability for violating regulations on the management of pharmaceutical precursor chemicals
a. Legal liability for smuggling, illegal trading of ephedrine compound preparations, etc.
b. Violation of pharmaceutical precursors Legal liability for the management of precursor chemicals
3. Legal liability for violation of the management of toxic drugs
Legal liability for the unauthorized production, acquisition, and distribution of toxic drugs
5. Legal liability for violation of relevant provisions of the Traditional Chinese Medicine Law
1. Legal liability for violation of the registration management regulations for holding traditional Chinese medicine clinics, preparing traditional Chinese medicine pieces, and entrusting the preparation of traditional Chinese medicine preparations
a. Legal liability for failing to do so when filing should be done, or for providing false materials when filing
b. Punishment for using traditional techniques to prepare traditional Chinese medicine preparations and failing to file in accordance with regulations or failing to prepare traditional Chinese medicine preparations in accordance with the requirements stated in the filing materials
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2. Legal liability for the use of highly toxic and highly toxic pesticides during the cultivation of Chinese medicinal materials
Legal liability for the illegal use of highly toxic and highly toxic pesticides
Eleventh Chapter Management of Medical Devices, Health Food and Cosmetics
1. Medical Device Management
1
.Basic requirements for medical device management
a. Definition of medical devices. Medical. Fully available online. www.med126.com
b. Classification of medical devices
c. Product registration and filing management
d. Medical device registration certificate format and filing voucher format
e. Medical device instructions and label management
2. Medical device business and use management
a. Medical device business classification management
b. Medical device business license management
c. Business quality Basic requirements for management regulations
d. Medical device use management
3. Handling of medical device adverse events and problem product reporting
a. Medical device adverse events Monitoring
b. Medical device re-evaluation and result processing
c. Medical device recall management
2. Health food management, formula foods for special medical purposes and infants Management of formula foods
Basic requirements for health food management
a.Definition of health food
b.Characteristics of health food
c. Health food approval number management
3. Cosmetics management
Basic requirements for cosmetics management
a. Definition and classification of cosmetics
b. Cosmetics production license and approval number management