Looking at the opportunities and challenges of the development of the pharmaceutical industry from the current status of clinical trials in my country!

Recent status of drug clinical trials in my country

According to the statistics of the Firestone Creation Database, the number of clinical trial registrations from 2016 to 2020 reached 4,814 (excluding BE), and 10 provinces (cities) including Jiangsu, Beijing, and Shanghai undertook over 80% of clinical trials nationwide.

Among them, the number of phase I clinical trial registrations was 2418, more than 50% of the total, and the number of phase IV clinical trials was 150, accounting for only 3.

1%.
Looking at the trend of clinical trials in my country in the past five years, the number of phase I, II, and III clinical trials has been increasing year by year; Phase IV has continued to maintain a stable number of trials, which also reflects my country’s investment in new drug research and development funds and the national economy Improve health awareness.

In the past, the protection of the rights and interests of subjects in clinical research in my country was still very imperfect.

Driven by economic interests, some medical institutions even charge subjects for free trial drugs (especially foreign drugs) provided by drug research and development units.

According to statistics from the Firestone Creation Database, as of April 8, 2021, there are 1044 GCP institutions nationwide (recorded), covering all provinces (municipalities and autonomous regions) across the country.

According to statistics from the Firestone Creation Database, as of April 8, 2021, there are 1044 GCP institutions nationwide (recorded), covering all provinces (municipalities and autonomous regions) across the country.

In the distribution of provinces (municipalities), Guangdong, Jiangsu, Shandong, Beijing, and Shanghai rank among the top five, accounting for nearly 35% of the total number of institutions, and they have undertaken the vast majority of clinical research in the country; while most provincial and municipal institutions in the western region There is a serious shortage, and even the number of the next ten provinces is less than that of Guangdong.

The main sticking point lies in the lack of strict and effective standardized management of clinical trials, the lack of uniform quality standards in all links, and the unclear responsibilities of relevant personnel, which are relatively random.

At the same time, the development of new drugs also requires a lot of financial support.

02

Opportunities for the development of my country's pharmaceutical industry

1.

The "14th Five-Year Plan" plan to deepen the reform of medical and health physique clearly proposes to promote the reform of the centralized procurement and use of drugs and consumables organized by the state, and develop high-end medical equipment.

2.

With the rapid development of my country's economy, people's needs for health continue to increase after their material needs are met.

In addition, with the continuous improvement of my country’s social security system, the gradual improvement of medical and health standards, and the improvement of people’s quality of life, my country’s aging population is increasing day by day.

3.

In recent years, the main economic indicators of China's pharmaceutical industry have gradually increased as a proportion of the country's total industrial volume, and the pharmaceutical industry's share in the national economy has also continued to increase.

With the adjustment of my country's industrial structure, although the pharmaceutical industry is still not a pillar industry of our country, its proportion in the national economy continues to increase, its position is increasingly prominent, and it has also become an important part of the national economy.
This provides an important historical opportunity for the vigorous development of my country's pharmaceutical industry.

4.
Implementation and implementation of pharmaceutical GMP and pharmaceutical GSP

The implementation and implementation of drug GMP (Good Manufacturing Practices) and GSP (Quality Management Practices) is conducive to improving the reputation of enterprises and products, enhancing competitiveness, improving the quality of pharmaceutical enterprise personnel, and improving the level of pharmaceutical production and operation.
, Is conducive to improving the economic benefits of pharmaceutical companies, so it creates a good development opportunity for the healthy development of my country's pharmaceutical industry and creates a bright prospect.

03

Problems and countermeasures in the development of my country's pharmaceutical industry

At present, the main problems in my country's pharmaceutical industry are concentrated in overcapacity, idleness, low industry concentration, insufficient R&D investment, low added value of pharmaceutical products, lack of brand building in the pharmaceutical industry, and industry management levels vary.

Overcapacity and idle capacity have reduced the profit margin of pharmaceutical companies and hindered the healthy development of my country's pharmaceutical industry.
The pharmaceutical industry should adjust the structure of the pharmaceutical industry, promptly eliminate outdated enterprises with high energy consumption and high pollution, eliminate high-cost and uncompetitive enterprises, vigorously develop advanced production enterprises with low energy consumption and low pollution, and develop low-cost and competitive enterprises.
Enterprises should adjust the structure of my country's pharmaceutical industry and promote the optimization and upgrading of the structure, thereby expanding profit margins and promoting the sustainable development of my country's pharmaceutical industry.

The low concentration, small scale, and dispersion of my country's pharmaceutical industry have made it difficult for China's pharmaceutical industry to form scale effects, and its international competitiveness is not strong.
Therefore, we need to promote my country's pharmaceutical industry to agglomerate and form scale effects.
The state can adopt the construction of pharmaceutical industrial parks to promote the agglomeration of similar pharmaceutical industries, promote exchanges and cooperation among similar pharmaceutical industries in the industrial park, extend the industrial chain of similar pharmaceutical industries, promote the joint use of infrastructure, information resources, advanced technology, etc.
, and improve pharmaceuticals.
Industry concentration, thus forming a scale effect, enhances the international competitiveness of China's pharmaceutical industry, and promotes my country's pharmaceutical industry to "go global.
"

Increasing investment in pharmaceutical science and technology and improving independent innovation capabilities play an important role in the development of the pharmaceutical industry.
On the one hand, the state must increase investment in research and development of the pharmaceutical industry, vigorously develop pharmaceutical science and technology, and accelerate technological innovation in the pharmaceutical industry.
On the other hand, pharmaceutical companies should strive to improve their independent innovation capabilities, vigorously promote the research and development of new drugs, and strive to increase the added value of pharmaceutical products, so as to promote the development and innovation of my country's pharmaceutical industry.

Chinese pharmaceutical companies must effectively strengthen brand building, build well-known brands, establish a good brand image, and strive to build consumer brand loyalty.
The state should establish and improve relevant laws and regulations, explore the establishment of a sound brand protection law in the pharmaceutical industry, effectively protect brands in the pharmaceutical industry, and crack down on all kinds of brand misappropriation.

At the same time, strengthen the regulation of the management behavior of pharmaceutical enterprises, resolutely crack down on all kinds of illegal activities that harm people's health, so as to improve the management level of pharmaceutical enterprises.
The managers of pharmaceutical companies must strictly abide by laws and disciplines, and strive to improve their own quality and management level, so that the economic activities of the companies are carried out within the scope of laws and regulations, so as to promote the healthy and sustainable development of my country's pharmaceutical industry.

to sum up

The next ten years will be a critical period for my country's new drug development level to catch up with the world.
In the new environment, the era of high profits by relying on a single drug has passed.
The future success is bound to belong to new drugs with a considerable number of clinical advantages, and pharmaceutical companies with continuous breakthroughs and innovations.