China will improve drug standards and international comparisons.

Recently, the “12th Five-Year Plan for National Drug Safety” officially issued by the State Council (hereinafter referred to as the “Planning”) proposes that the national drug standards improvement action plan and the implementation of the national medical device standard improvement action plan will be implemented during the 12th Five-Year Plan period. Improving the quality of generic drugs and improving the national drug standards management system centered on the "Pharmacopoeia of the People's Republic of China". The "planning" specifically requires that all chemical and biological products standards meet or approach international standards, and Chinese medicine standards dominate international standards. More than 90% of medical devices use international standards. Experts pointed out that improving drug standards and drug quality is the focus of the five-year planning period.

From imitation standards to other effects

The generic drugs approved before the implementation of the "Drug Registration Regulations" revised in 2007 will be evaluated in batches and in conformity with the quality of the generic drugs. The generic medicines included in the National Essential Drug List and clinical trials will be completed by 2015.

Industry experts said that during the “12th Five-Year Plan” proposed by the “Plan”, all chemical and biological products standards meet or approach international standards, which is a rather arduous task.

At present, more than 90% of the products produced by domestic companies are still generic drugs, but in the relatively long period of time in the future, China's pharmaceutical industry still needs to use generic drugs as the main support. Planning also lists separate quality improvement requirements for generic drugs.

The “planning” requires that the generic drugs approved before the implementation of the “Drug Registration Regulations” revised in 2007 be evaluated in batches and in batches with generic drugs for quality conformance, including the national essential drug list and common clinical generic drugs in 2015. Years ago to complete, failed to re-register after failing to pass the quality conformance assessment, and write off its drug approval certificate. Pharmaceutical manufacturers must, in accordance with the Administrative Measures for Drug Registration, conduct a comprehensive comparative study of their generic drugs and generic drugs as the basis for applying for re-registration.

Shen Xianji, deputy director of the Expert Committee of the China Chemical Pharmaceutical Industry Association, said that in recent years, China's generic medicine is gradually shifting from the original imitation standards to imitation quality and imitation efficacy. The "Drug Registration Regulations" revised in 2007 proposed the requirements for bioequivalence. Now further requirements for comprehensive comparison will undoubtedly greatly increase the quality of generic drugs.

Long-term cost test

The new version of the GMP reform costs, the implementation of pharmaceutical electronic regulatory fees, environmental protection and management costs and the rising costs of raw materials and human resources, will directly test the viability of enterprises.

Pan Guangcheng, vice president of the China Chemical Pharmaceutical Industry Association, believes that the overall increase in quality requirements for generic drugs will undoubtedly increase costs. The company will face a long-term cost test.

Song Ruilin, executive president of the China Pharmaceutical Industry Research and Development Association, believes that due to the fact that most of the medicines currently circulating in the market are registered before 2007, it is necessary to give enterprises sufficient time to conduct quality consistency assessment.

The statistics obtained by the reporter from the SFDA show that in 2011, there were 146 enterprises in China that had passed the new GMP certification. In the same year, there were 769 companies that passed the 98 version of GMP certification.

According to Yu Mingde, president of the Chinese Pharmaceutical Enterprise Management Association, the overall speed of the new version of GMP should also be accelerated.

Shen Yinji also believes that it is important to avoid the phenomenon of emergency rushing before closing the deadline.

The reporter learned that the above-mentioned GMP applicants have not implemented the new version of GMP when applying for certification. For cost considerations, most companies are more willing to transition to low-standard versions in the past few years.

At present, companies do not have the motivation to actively raise standards. The reason is that the incentive mechanism is not in place. There is no effective and effective incentive mechanism for companies to actively carry out process optimization and improve product quality.

“Companies are being squeezed by both rising costs and falling drug prices.” A company official said: “Companies also look forward to other policy support, but the basic point is still on the price of drugs.”

Yu Mingde said that the mobilization of corporate certification enthusiasm to ensure that certified companies can strictly in accordance with the GMP requirements for production, the need for policy guidance and encouragement, the need for medical insurance, social security, price, tendering and other related policy system of convergence and cooperation.

Superior or superior

In the future, generic drugs should work hard on bioavailability, efficacy, safety, and stability. At the same time, they should actively explore the development of new formulations and new compounds to avoid large-scale low-level repetition and competition.

The drug manufacturers' R&D investment is insufficient, their innovation ability is not strong, and there is a big gap between the quality of some generic drugs and the international advanced level.

"The state hopes to pass the high requirements for drug safety and severe punishment measures to achieve industrial restructuring, resolve the key issues of low industrial concentration, and inadequate quality of pharmaceuticals, or will allow China's pharmaceutical industry to enter a sound stage of development from a rapid development stage." Analysts believe that high-quality companies with research and development advantages, cost advantages, or scale advantages will become beneficiaries in the process of scouring the sands, and generic drugs are still promising in the future.

According to statistics, there will still be more than 100 patents in the world within the next five years, which is undoubtedly an opportunity for domestic enterprises.

“The survival of generic drugs should focus on improving their own quality, adhere to the ideas of ingenuity, ingenuity, and creativity, and then move on to a route based on originality.” A pharmacist expert said: “In the future, generic drugs should be used for bioavailability. Efficacy, safety, and stability should be worked hard. At the same time, we should actively explore the development of new formulations and new compounds to avoid large-scale low-level repetition and competition."

It is understood that in the past two years, the variety structure of China's drug declaration has been greatly improved, and more and more innovative drugs have been introduced. However, the situation of the simultaneous declaration of dozens of companies of one species still exists, and most generic pharmaceutical companies are still in the stage of price competition.

The bad news is that for domestic companies, there are still more and more multinational pharmaceutical companies in the field of generic drugs.

Earlier this year, British company AstraZeneca announced that it invested 230 million U.S. dollars in the construction of AstraZeneca (China) Co., Ltd. in Taizhou, Jiangsu. This project will become the company's largest independent production base in the world, and it will be clearly positioned as a generic pharmaceutical production base.

In fact, not only AstraZeneca, Pfizer and Hisun Pharmaceutical, Xiansheng Pharmaceutical, and the United States, Merck, Fosun Pharma, and Swiss Longsha have formed joint ventures, targeting drugs whose patents are about to expire, and Novartis In the early years, it was through the use of Sandoz's generic drugs in China to establish new territories.