Part 1.
Current status of the pharmaceutical and biotechnology industry

Chapter 01 Current Status of the Domestic Pharmaceutical and Biotechnology Industry
Chapter 02: Current Status of the Global Pharmaceutical Industry

Part 2.
New drug development

Chapter 01 Understanding Drugs
Chapter 02 Understanding New Drug Development

Part 3.
clinical trials

Chapter 01 Nonclinical Trials (Good Laboratory Practice, GLP)
Chapter 02 Clinical Trials (Good Clinical Practice, GCP)

Part 4.
Pharmaceutical licensing

Chapter 01 Pharmaceutical Approval System
Chapter 02 Post-Market Safety Management Information for Pharmaceuticals, etc.

Part 5.
Pharmaceutical prices

Chapter 01 Drug Price Listing
Chapter 02 Post-Pharmaceutical Price Management System

Part 6.
National Health Insurance

Chapter 01 National Health Insurance
Chapter 02 Health Insurance and Medical Expenses

Part 7.
Pharmaceutical manufacturing quality control

Chapter 01 Good Manufacturing Practices (GMP)
Chapter 02 Validation

Part 8.
Pharmaceutical distribution

Part 9.
Pharmaceutical and Biomarketing

Chapter 01 What is Pharmaceutical Biomarketing?
Chapter 02 New Changes in Pharmaceutical and Biomarketing

The pharmaceutical and biotechnology industry is an industry that directly affects human life and health. It is an industry that researches and develops new drug candidates, undergoes GLP and GCP processes, receives approval for the drug, and then produces, sells, and markets it in GMP facilities. It then goes through a post-marketing re-examination and re-evaluation process to continuously prove its safety and efficacy. It is strictly regulated by the government.
It is also a high-tech value-added industry that encompasses all processes from research and development for new drug development to production and sales of raw materials and finished pharmaceutical products. It is a future new growth engine industry with high technology intensity and the potential to create very high added value depending on whether or not new products are developed. It is an industry with distinct characteristics that set it apart from other industries, and it is an industry that requires a high level of expertise in each field.


In order to understand the pharmaceutical and biotechnology industry more accurately, I provided practical problems in a practical book on the pharmaceutical and biotechnology industry. However, many readers requested answers to these practical problems, so I wrote this book.


The practical problems were created by the author from 2016 to the present, when he was studying pharmaceutical industry-related subjects such as Introduction to Pharmaceutical Industry, Clinical Trial Management, Pharmaceutical Licensing, Health Insurance Policy, Introduction to Pharmaceutical Pricing Policy, Pharmaceutical Industry Policy, GMP, Production Management, Pharmaceutical Marketing, Global Pharmaceutical Marketing, and Bio-Industry Market Evaluation, so that all students could participate, think, and ask questions to more easily understand the questions they had.


The pharmaceutical and biotechnology industry, unlike other industries, is a field that deals with the diseases and health of patients, so it is regulated, and it is necessary to understand that various related departments and people are involved until the patients, the final beneficiaries of the medicines, receive treatment, including understanding the pharmaceutical industry, the new drug development process, clinical trial stage, drug approval/licensing decision process, post-marketing drug safety management, production, GMP, Validation, GSP, insurance drug prices and guideline decisions, hospital purchases, and doctors' prescription decisions.
In other words, the pharmaceutical industry must first understand the specific circumstances of the overall pharmaceutical industry and the current and future pharmaceutical industry market trends.
For this reason, the answers to practical problems may vary depending on the positions of various stakeholders, including regulatory agencies, pharmaceutical companies, distribution companies, medical professionals and pharmacies, who are the primary customers of the pharmaceutical industry, and patients, who are the final consumers of pharmaceuticals.


This book provides comprehensive knowledge and answers to practical questions in each chapter of the pharmaceutical and biotechnology industry practice book to enable you to more accurately understand the comprehensive knowledge so that you can perform your work by arming yourself with a comprehensive and integrated insight, including the overview of the pharmaceutical industry, which is the practical area of ​​pharmaceutical and biotechnology companies, drug product planning, new drug candidate research, drug research and development, GLP, GCP, drug approval, drug safety management, drug pricing, GSP, GMP, Validation, and sales and marketing.
Rather than providing a correct answer to the question, this article presents the author's subjective thoughts, opinions, and alternatives.
I hope this book will be of some help to students seeking to enter the pharmaceutical and biotechnology industries and to those working at pharmaceutical and biotechnology companies, thereby contributing to the advancement of the industry.