Pharmaceutical administration is a sub-discipline of the pharmaceutical sciences, which has the characteristics of a social science and use social, behavioral, administrative, economic, and legal sciences to study the influencing social factors and proper management system to ensure the quality of drug and pharmaceutical care and enhance the benign development of pharmacy business.

The main content of this course includes the drug definition, and drug classification, pharmacist functions, pharmaceutical organization and policy system, managerial principles and regulations and laws of pharmaceutical research, production, distribution and clinical use in China, and judge the legal and illegal behaviors according to the China’s pharmaceutical laws.

The teaching task of this course is to inculcate the pharmacy student with an understanding of administrative, economic, behavioral, and legal concepts in the pharmacy practices which help them to adapt to changing roles and functions in the future. It is a compulsory professional course to the pharmacy students. This course need class 32 hours totally.

 

Chapter 1st Introduction (4 class hours)

Purpose and requirements:

1. To master the definition and goals of pharmaceutical administration, curriculum system of discipline of pharmacy administration

2. To understand the differences between the discipline of pharmaceutical administration and other pharmaceutical sciences

Content:

Definition of Pharmaceutical Administration; The goals of Pharmaceutical Administration; Definition and objective of the discipline of Pharmaceutical Administration; Curriculum system of the discipline of Pharmaceutical Administration; Research fields of Pharmaceutical Administration

 

Chapter 2nd Drug and Pharmacist (4 class hours)

Purpose and requirements:

1. To master the definitions of a human drug, counterfeit drugs and substandard drugs in China.

2. To be familiar with the professional functions of a licensed pharmacist

Content:

Concepts of drug, counterfeit drug or substandard drug, new drug, originator drug, generic drug; Drug classification; Attributes of drugs; Essential roles & functions of pharmacists; Licensing requirements for pharmacists.

 

Chapter 3th System and Functions of Pharmaceutical Organizations (4 class hours)

Purpose and requirements:

1. To master the organization system of drug administration supervision in China

2. To be familiar with the administrative functions of China Drug and Food Administration

3. To understand the system and functions of WHO and FDA

Content:

Drug supervision and management organization system in China; Types of pharmacy practice units and pharmaceutical associations in China; The system and functions of WHO and FDA and other foreign pharmaceutical affairs

 

Chapter 4th National Drug Policy and Essential Drug Policy (4 class hours)

Purpose and requirements:

1. To master the key components of a national drug policy

2. To be familiar with the main contents of China’s essential drug policy

3. To understand a successful pharmaceutical policy

Content:

Definition of pharmaceutical policy and national drug policy; Objectives of a national drug policy; Key components of a national drug policy; Main contents of China’s essential drug policy; Evaluation method of the impact of a pharmaceutical policy

Chapter 5th Drug Administration Law of the People's Republic of China and pharmaceutical law system (6 class hours)

Purpose and requirements:

1. To master the definition and aim and core contents of drug administration law of China

2. To be familiar with the new drug approval process and the legal liabilities for producing and selling counterfeit drugs or substandard drugs in China

3. To understand pharmaceutical law system

Content:

Definition of Law; Pharmaceutical law system in China; The main contents of drug administration law of China; Drug quality standard; New drug approval process; Drug manufacturing and supplying management; legal liabilities for producing and selling counterfeit drugs or substandard drugs; Case analysis and discussion.

 

Chapter 6th Good manufacturing practices for pharmaceutical products in China (4 class hours)

Purpose and requirements:

1. To master the definition and aims and main provisions of good manufacturing practices.

2. To be familiar with the definitions of quality and quality risk management.

3. To understand the history of quality management

Content:

Definitions of quality and quality management; Definition of quality risk management; Evaluation tools of risk management; Aims and roles of GMP; The development history of good manufacturing practices; Main provisions for quality management, personnel, equipment, materials and products, documentation management, production management in the good manufacturing practices of China.

 

Chapter 7th Good supply practice for pharmaceutical products (4 class hours)

Purpose and requirements:

1. To master the definition of Good Supply Practices and the requirements of drug procurement for a distributor in accordance with the good supply practices of China.

2. To be familiar with the operation procedures for drug retail in the pharmacy.

3. To understand the regulations of online pharmacies in China.

Content:

Definitions of distribution and good distribution practices and good supplying practices; Value chain for pharmaceutical products; Main contents of Good Supplying practices in China; Quality management for wholesale of pharmaceutical products; The supply path of a disaster drug; Quality management for retail of pharmaceutical products; China’s policies on online pharmacies

 

Chapter 8 th Adverse Drug Reaction Reporting and Monitoring system (2 class hours)

Purpose and requirements:

1. To master the definition of adverse drug reactions and reporting and monitoring procedures of adverse drug reactions in China.

2. To be familiar with the types of adverse drug reactions and the methods for estimating the probability of adverse drug reactions.

3. To understand the Adverse Event Reporting System in U.S. and UK

Content:

Definition of adverse drug reactions; Types of adverse drug reactions; The methods for estimating the probability of adverse drug reactions; FDA's Adverse Event Reporting System (FAERS); Adverse Event Reporting System in the United Kingdom; The reporting and monitoring procedures of adverse drug reactions in China; Detection methods of Adverse Drug Reaction