The new version of GMP proposes higher requirements for policy support to improve drug quality

According to IMS data analysis, China's pharmaceutical industry's total output value has risen from the eleventh in 1999 to sixth place today: By 2013, it will rise to third place, behind the United States and Japan. At the same time, the Chinese pharmaceutical market is also growing rapidly. According to relevant institutional analysis, by the end of the “Twelfth Five-Year Plan”, the Chinese pharmaceutical market will surpass Japan and become the world’s second largest pharmaceutical market, which will greatly stimulate the development of China’s pharmaceutical industry. Pan Guangcheng believes that the next few years will be a critical period for the development of China's pharmaceutical industry. Market growth will accelerate substantially, and it will also face enormous challenges. How to ensure product quality and safety is one of the most severe challenges. "Improve the quality of drugs is an unshirkable responsibility of the company." He stressed.

With the development of the pharmaceutical industry, the quality and safety of pharmaceuticals have become more and more concerned by all sectors of society, and have become the first priority in the pharmaceutical industry. In recent years, through the unremitting efforts of the government and enterprises, Chinese pharmaceutical companies have achieved certain results in improving the quality of medicines. In particular, the GMP promotion and certification system is quite "awesome" in terms of improving drug quality and enhancing the global competitiveness of China's pharmaceutical companies. However, it cannot be avoided that in recent years, the occurrence of phytotoxicity incidents has also occurred in companies that have passed GMP certification. “Because of the different strengths of companies in implementing quality management system standards, even the drugs produced under the same quality standards, the internal quality and clinical efficacy are still uneven.” An industry source who declined to be named said that these drug incidents are not only It has caused great harm to the patient, increased the burden on the country's health resources, and also had an adverse impact on the international reputation of the Chinese pharmaceutical industry.

What is even more worrying is that although the new medical reform is continuing to deepen, due to the complexity and arduous nature of the reform, many problems that plagued the pharmaceutical industry are difficult to resolve for a while, making the improvement of pharmaceutical quality seem to be “long way to go”. For example, under the current system of centralized tendering and procurement of drugs, some local governments' policies of “only low prices are taken” have affected the development of the pharmaceutical industry, and have also brought hidden dangers to the safety of people’s medications. Li Zhenjiang, deputy to the National People's Congress and chairman and president of Shenwei Pharmaceuticals, told reporters that since last year, drug supervisors have continued to report to him that problems have been found in spot checks on essential drugs in some places. He hopes that Li Zhenjiang can “standardize the tendering system for drugs and ensure the quality of drugs. "As a proposal submitted to the National People's Congress to arouse the attention of the government and the community." "In some regions, only low prices are the enterprises that win the bid under the policy. Most of them can't guarantee continuous supply, and they can't guarantee the quality of medicines." Li Zhenjiang expressed his deep concern.

“Usually, there are four thresholds in drug marketing and economics evaluation: safety, effectiveness, quality, and economy. Quality is the most basic indicator and guarantee. If quality cannot be guaranteed, then it is safe and effective. Economics?” said Dr. Chen Yi, Director of Health Economic Affairs at the China Pharmaceutical Industry Research and Development Committee of the China Association of Enterprises with Foreign Investment (RDPAC).

Industry enthusiasm and anxiety The GMP revision is undoubtedly an opportunity to improve the quality of medicines. The new version of GMP, which is in line with international standards, puts forward higher requirements for enterprises and will also become a booster and accelerator for industrial restructuring and healthy development.

According to people in the industry, the key to improving the quality of drugs is to increase the enthusiasm and initiative of enterprises. The upcoming implementation of the new version of GMP has begun to trigger the enthusiasm of large-scale pharmaceutical companies. “The new version of GMP has improved the certification standards, raised the threshold of the industry, and will also bring about an increase in industry concentration. It will help build several or even hundreds of aircraft carrier-sized large-scale pharmaceutical companies. This is a powerful enterprise. The good news is good.” Li Zhenjiang said that in order to seize this opportunity, Shenwei Pharmaceutical has invested 4 billion yuan since 2009 to begin construction of the “Shenwei Modern Chinese Medicine Industrial Park” and hired internationally renowned experts from design, craftsmanship, processes, etc. Considering everything, we are committed to becoming "NO. 1" certified by the new GMP. "In order to improve the quality of medicines, Shenwei Pharmaceuticals is willing to invest and dare to invest in it," Li Zhenjiang said forcefully.

In the interview, the reporter learned that, like Shenwei Pharmaceutical, many companies began to “get in touch with the international” at the beginning of the GMP revision news, carried out more stringent quality system management, and went to the national food and drug supervision before the release of the new GMP. The SFDA filed a certification application. At the same time, the primary factor that has long plagued China’s preparation products “going out” is also due to the fact that the gap between China's pharmaceutical production quality management system and related standards and the international advanced level is too great. Therefore, for those enterprises that are committed to becoming bigger and stronger and going abroad, they are more active in preparing for the new version of GMP certification.

However, as Li Zhenjiang said, due to the huge investment, “many companies are powerless”, not all companies have the courage to invest and dare to invest. The implementation of the new version of GMP means that quite a few companies will withdraw. Even for large companies, the investment in passing the new GMP certification is not a small amount. Pan Guangcheng told reporters that people in the industry had estimated that in the new version of GMP certification, the entire industry will increase input of 200 billion to 300 billion yuan in the future. Strengthening quality control and improving the level of drug quality management is a complicated system project. In addition to technical and management factors, it also requires a lot of manpower and financial resources. The investment for strengthening the drug safety system is a necessary guarantee for improving the quality of drugs, but it also brings about a substantial increase in costs. Between quality and cost, based on market orientation, companies must make choices.

For multinational companies, the implementation of the new version of GMP will hardly cause any obstacles. However, in the pharmaceutical industry, the continuous improvement of product quality is an eternal theme. This is particularly true of multinational pharmaceutical companies that have established a foothold in the Chinese pharmaceutical market with proprietary drugs, original research drugs and brand drugs. "The goal of the new medical reform is to solve the problem of 'expensive and difficult to see the doctor', but I think we must also ensure 'see the disease'," said Chen Yi.

Looking forward to the convergence of the incentive mechanism Clearly, the production and use of high-quality drugs is a good foundation for "seeing good disease." The mature international pharmaceutical market development experience shows that various incentive policies of the pharmaceutical industry have played a positive role in encouraging pharmaceutical companies to improve drug quality and promote drug innovation at various stages of development. "Recommended that the government encourages production enterprises to continue technological upgrading, quality innovation, and strengthen investment in pharmaceutical quality management systems. At the same time, it establishes incentives for price levers, medical insurance reimbursement, and clinical use management to encourage companies to actively improve drug quality. Active policy guidance is crucial to the development of China's pharmaceutical industry," said the person in charge of RDPAC.

Global practice and China's development experience have proven that GMP certification is a scientific and systematic management mechanism that can inhibit low-level drug development and guarantee the quality of drugs. Therefore, after the SFDA releases and implements the 2010 edition of the Pharmacopoeia, it will soon release a new version of GMP. This is undoubtedly another measure to strengthen drug quality supervision and system construction, which will effectively promote the healthy development of China's pharmaceutical industry. Pan Guangcheng stated that the implementation of the new version of GMP will be a good policy guide for pharmaceutical companies to improve the quality of pharmaceuticals. The government should provide support for capital, credit, and taxation in the process of pharmaceutical enterprises' reform in accordance with the requirements of the new GMP, and at the same time give enterprises reasonable profit margins. To ensure that companies continue to invest in improving drug quality.

At present, the National Development and Reform Commission is in the process of reforming the pharmaceutical pricing mechanism. The industry is unanimously of the view that the pricing mechanism with higher prices and better prices will help the industry improve the quality of medicines. In early 2009, Ernst & Young (China) was commissioned by RDPAC to complete a research project of “reasonable drug prices to promote drug quality improvement and scientific and technological innovation” within 9 months. The quality factors of generic chemicals and the price evaluation factors that can be considered were preliminary Explore. "The quality of medicines is not tested, but depends on a complete set of quality system to support the production." Dr. Car Yan, the project leader, believes that differential pricing is an important driving force for encouraging innovation and promoting the improvement of drug quality. Pan Guangcheng told reporters that in the relevant research conducted by the China Chemical Industry Association, some local companies have called for a higher quality and better price mechanism in the pharmaceutical industry. At the same time, under the same quality standards, the prices of local and foreign-funded enterprises’ products should be “unified national treatment”, which will not only help the company improve the quality of drugs, but also help establish a fair and just competitive environment.

In recent years, the promotion of pharmaceutical quality management concepts in the pharmaceutical industry has become an important task for the China Chemical Pharmaceutical Industry Association, RDPAC and other industry organizations. The concept of “the quality of pharmaceuticals is produced” has penetrated into the entire industry. At the same time, the pharmaceutical quality management system should run through the entire process from production to market, and the company’s quality management system should be responsible for drug production, clinical validation, pharmacovigilance, and medicine. Management in areas such as information and medical affairs is critical. The establishment and maintenance of a quality system for pharmaceutical companies requires a lot of investment, both hardware and software," said the person in charge of RDPAC. Domestic and foreign experts agreed that from the new Pharmacopoeia and the new GMP (Draft for Soliciting Opinions), we can see that at present, there is not much difference between China's pharmaceuticals in terms of quality control requirements and the compliance of the company’s hardware with the international advanced level. The gap between enterprises and foreign-funded enterprises is in management awareness." According to Chen Yi, domestic companies must establish a concept of high quality. The quality of medicines should not only be reflected in the end products, but should establish a practicable pharmaceutical quality management system to purchase, produce, circulate, clinically use, and drug products from raw and auxiliary materials. The whole process of quality management such as vigilance, post-listing evaluation, etc. Therefore, the government's establishment of incentive policies that are consistent with the direction of industrial development and national supervision will help improve the quality of medicines. It is recommended to find a few points on the management system and provide policy support. For example, if an enterprise passes the new GMP certification, or if the product is exported, it can enjoy the corresponding quality rating treatment.

For enterprises, while calling for policy support, the most important thing is to improve internal strength. “The quality control practices and experiences of large companies for large varieties will certainly greatly improve the overall quality control level of the industry if they can be promoted.” An Haoyi, Chairman of the Board of Sichuan Traditional Chinese Medicine believes that the state should have a demonstration The role of the company to give incentives. For example, enterprises and related products that actively improve drug quality standards shall be encouraged and supported in drug pricing mechanism, quality evaluation, medical insurance, bidding, and taxation.