The consistency evaluation started in January 2012 “Notice on Printing and Distributing the National Drug Safety’Twelfth Five-Year Plan’ (Guo Fa  No. 5, hereinafter referred to as the “Notice”)” and “National Food and Drug Supervision” in February 2013. Notice of the Administration on Carrying out the Quality Consistency Evaluation of Generic Drugs“, since then, consistency evaluation has become a hot word in the pharmaceutical industry. On September 19, 2015, the 3rd China-ASEAN Pharmaceutical Cooperation and Development Summit Forum was held in Nanning. The many favorable policies of the “Introduction to the Quality Consistency Evaluation of Generic Drugs” by Mr. Li Bo of the China Inspection Institute have set off a new level of consistency evaluation. climax. What is the purpose of carrying out consistency evaluation?
Historical origin: my country’s drug R&D registration has gone through several stages:
The first stage: (1963-1978): In 1963, the Ministry of Health, the Ministry of Chemical Industry, and the Ministry of Commerce jointly issued the “Regulations on Pharmaceutical Administration”. Two years later in 1965, the Ministry of Health and the Ministry of Chemical Industry jointly issued the “Medicine Although these regulations of the New Product Management Regulations stipulated the drug registration approval management measures, due to the period of blockade by European and American countries at that time, the domestic medical technology was backward, coupled with the ten-year turmoil period, the standards and requirements of various regions were not unified, as well as the technical problems. Being backward, standardization is impossible to talk about, so many problems remain.
The second stage (1979-1998): After the reform and opening up, the Ministry of Health successively issued a series of ministerial regulations such as the “New Drug Administration Measures” (1979) and the “New Drug Approval Measures” (1985). Insufficient accumulation of scientific knowledge and experience. In order to meet the needs of domestic drugs, there were problems that could not be solved at that time, such as lowering quality standards and unscientific clinical trial schemes. Although the new drug approval authority was recovered from the Ministry of Health after 1985, due to experience and technology The lack of accumulation has made domestic drug standards lower than their international counterparts.
The third stage (1999-2006): The State established the State Drug Administration, which specializes in the management of drugs, and is successively in the “New Drug Approval Measures (Revised)” (1999), “Drug Registration Management Measures (Trial)” (2002) In the three phases of the “Administrative Measures for Drug Registration” (2005), it was in the embryonic stage of R&D registration before 2002. The level of drug R&D technology is very low, and technical personnel who understand R&D are also very scarce. They are mainly concentrated in universities and state-owned research. Institutions, as there is no marketization, research and development are relatively standardized. Afterwards, through the “Administrative Measures for Drug Registration (Trial)” (2002) and “Administrative Measures on Drug Registration” (2005), pharmaceutical research and development entered a period of “rapid development”. To gain the world”, drug research and development has entered a “fascinating” period of “data + relationship”. Almost few companies are willing to immerse themselves in testing, and they have entered the stage of fabricating data and copying materials; during this period, some companies have kept secrets to prevent product technology leakage , There is also the compelling phenomenon of deliberately falsifying data. With the accidents of Zheng Xiaoyu, Cao Wenzhuang and others in 2006, the pharmaceutical research and development industry returned to a period of silence. During the period, the National Bureau upgraded the local drug standards to national standards. The policy is not bad. Although the standards have been upgraded, the gap with the international standards is still obvious. The reasons are clear to everyone. The biggest result of this stage is that the people no longer lack medicines, but whether you dare to use them and can afford them.
The fourth stage (2007 to present): In 2007, the State Food and Drug Administration promulgated Order 28 “Administrative Measures for Drug Registration” and the CTD format declaration system started in 2011. Some of the previous policies were adjusted and the review standard was improved. However, during this period, the theory of only foreign standards appeared. It seems that as long as we meet foreign standards such as USP, EP, BP, and JP, we will be in line with international standards, but we have forgotten that the fundamental purpose of our medicine is clinical efficacy and safety.
To be fair, Director Zheng Xiaoyu still left at least two things for our industry-opening up the standardization of drug registration management and the GMP era. Borrowing “taking history as a mirror, we can know the rise and fall; taking people as a mirror, we can understand the gains and losses”; the consistency evaluation is not to deny the predecessors and liquidate the old accounts of history, but to find a way more suitable for our industry on the steps of the predecessors and solve the legacy of history The problem and the technical problem that could not be solved in the previous historical period-how to make the clinical efficacy and safety of generic drugs similar or consistent with the original drugs.
According to the established quality standards (pharmacopoeia and registration standards), the qualification rate of the drug market in the “National Drug Evaluation Sampling Work” started by the National Bureau in 2008 is “high”, but in the process of clinical use, “the same products produced by different manufacturers Preparations, and even different batch numbers produced by the same manufacturer, will have different effects after patients take them, and some are safe and ineffective or safe but have poor efficacy.” Especially some domestic generic drugs for oral solid preparations are far from clinically effective compared with imported original research drugs. . Although the country raises the standards every five years and promulgates new pharmacopoeias, and the product standards of enterprises are also improving every time, the improvement in efficacy is limited. As a result, doctors and patients have some doubts about domestic drugs, directly causing the original research drugs to occupy most of the high-end market, but domestic drugs are caught in low-price competition. In the endless market struggle, the typical “people are eating meat,” We can only drink soup” phenomenon. On the other hand, domestic preparations exported to developed countries such as Europe and the United States are rare, while our neighbor India occupies one-third of the world’s generic drug market, which also proves that our preparations have fallen behind and we need to catch up. Therefore, the consistency evaluation is not to reduce the number of approval documents and crack down on small and medium-sized enterprises, but to guide enterprises to carry out secondary development of existing products to improve the technical level, and truly achieve that the clinical efficacy and safety of generic drugs are similar or consistent with the original drugs.
The road to the future:
In the trend of economic globalization, what our company has to face is the competition of multinational pharmaceutical companies with a long history and rich experience. What needs to be considered is the long-term development of the company. In the future, how to not be eliminated in market competition is worthy of our company’s deep thinking.
Compared with original drugs, generic drugs are cheaper. While ensuring the availability of drugs, they can replace original products, reduce medical expenditures, and play an important role in public health care. They are the mainstream in developing countries such as China and India. Due to the high prices of original research drugs in developed countries such as Europe and the United States, generic drugs also occupy a certain market. Therefore, when companies have limited technical strength and capital, it is a way of development to develop high-quality generic drugs and then move towards innovative drugs. The development of the pharmaceutical industry in India has shown positively that generic drugs have a lot to offer. However, this is not to say that generic drugs have no technical content. The current status of generic drugs in my country and the slow progress in consistency evaluation just show that it is easy to make generic drugs, but it is very challenging to make the clinical efficacy similar or consistent with the original drug. . Through the evaluation of the consistency of generic drugs, companies reveal the true gap between the clinical efficacy of generic drugs and original drugs, so as to continuously accumulate preparation development experience and knowledge, enhance their technical strength, enhance the confidence of doctors and patients in their products, and open up the world The market seeks new development space.
Consistency evaluation is the only way for the development of generic drugs. It is a new quality evaluation system. It is a manifestation of the QbD (drug by design) concept in the development of generic drugs. It is a technological revolution in preparations.