|2015 is a special year, which has always been shrouded in doubts about the war. The world economy is declining, oil prices are plummeting, refugees are flocking to Europe, terrorist attacks are rampant, and confidence is being combated everywhere. Although the last quarter of the domestic "double 11" and the United States "Black Friday" rush to buy news, but the global economy into a slow and fragile recovery cycle is an indisputable fact.
When the economies of various countries enter the period of deep adjustment and transformation and become the new normal of the world economy, the pharmaceutical industry closely related to the economy has also ushered in a year of great change.
2015 is a key policy year. First, in the first half of the year, the documents on improving the centralized drug procurement in public hospitals were issued, which made it clear that the bidding implemented classified procurement, implemented volume procurement, cancelled government pricing, and played a role in controlling medical insurance fees. Subsequently, CFDA issued the decision on Amending the drug administration law of the people's Republic of China, as well as the classification rules for medical devices and other relevant documents issued in July.
In addition to the relevant domestic pharmaceutical policies issued in succession, the domestic and international pharmaceutical industry also has heavy news, marking 2015 is not an ordinary year, and the impact of major policies and news on the industry will be far-reaching.
Consistency evaluation of generic drugs
Recently, the documents about the consistency evaluation of generic drugs issued frequently have a profound impact on enterprises.
In August, the State Council's opinions on the reform of the review and approval system for pharmaceutical and medical devices (GF  No. 44) proposed the overall objectives of improving the quality of review and approval, solving the backlog of registration applications, improving the quality of generic drugs, encouraging research and creation of new drugs, and improving the transparency of review and approval.
At the beginning of November, the guiding principles for selection and determination of reference preparations of common oral solid preparations (Draft for comments), the guiding principles for determination and comparison of dissolution curve of common oral solid preparations (Draft for comments), and the guiding principles for research on bioequivalence of human body for quality consistency evaluation of generic drugs (Draft for comments) set technical implementation indicators for enterprises.
In the middle of November, the announcement of soliciting opinions on the implementation of priority review and approval for solving the backlog of drug registration applications (Draft for comments) and opinions on the implementation of conformity evaluation of quality and efficacy of generic drugs (Draft for comments) pushed the re evaluation of generic drugs to a climax.
According to the requirements of the announcement on self inspection and verification of drug clinical trial data (No. 117 in 2015) and the announcement on self inspection of drug clinical trial institutions (No. 197 in 2015), CFDA released the announcement that 11 drug registration applications of 8 enterprises were not approved, which made the industry focus the most, marking the official opening of the battle. Then, hundreds of drug registration applications of more than 100 enterprises were withdrawn, and a roadmap for policy implementation was drawn.
Reform of drug examination system
At the beginning of November, CFDA issued a notice (No. 220, 2015) to solicit the opinions of two draft proposals, i.e. the pilot scheme of drug listing license holder system and the work scheme of chemical drug registration and classification reform, which immediately triggered a heated discussion in the industry.
As a relatively popular system in the world, the system of listing licensors has a strong sense of encouraging innovation, and can restrain the low-level duplication of pharmaceutical enterprises from the source, thus promoting the rapid development of China's pharmaceutical industry. At the same time, it also means that the responsibilities of licensors and supervisors will be further increased. At present, drug safety incidents occur frequently. How to avoid the industry's confusion is the key point to be considered in the next step.
The subversive changes in the reform of chemical drug registration and classification are unexpected. The drug classification that has been used for many years has won countless dividends for numerous enterprises that are fond of three kinds of new drugs. And this reform tries to be in line with the international standards, from "China new" to "global new" and "with obvious clinical advantages" required by improved new drugs. It excludes "pseudo innovation" from new drugs and a series of policy preferences, so that people or enterprises with real innovation spirit can put down the burden and move forward boldly. However, the application requirements for generic drugs of categories 3 to 5 have been improved, especially when the designated reference preparation must be the original research or internationally recognized drug.
Tu youyou won the Nobel Prize
In October, Tu youyou won the Nobel Prize in medicine for artemisinin research, which is undoubtedly a great event to inspire Chinese people. The Chinese people's Nobel complex has a long history. Every year, in the Nobel season, they are entangled and even haunted. From the perspective of Literature Awards and medical awards that the early Chinese people most expected and thought were the hardest to win in the field of awards, under the influence of national strength, self-confidence and efforts of Chinese people and other factors, it shows that "nothing in the world is difficult but people with a heart". From then on, the frontier research will no longer be absent from China.
"Chinese medicine is a great treasure house, which should be explored and improved," Tu youyou said in the award-winning speech. Artemisinin is found in this treasure house. Traditional Chinese medicine and Western medicine have no advantages or disadvantages. Everyone has their own advantages. If they combine organically and complement each other, they will have greater development potential. Information collection and accurate analysis are the basis of successful research findings. As for the use of Artemisia as medicine, it was first seen in the silk book "52 disease Prescriptions" of the Han Dynasty, and later in the classics of Shennong Materia Medica, the supplement of Leigong processing, compendium of Materia Medica and so on. However, the method of extraction of low boiling point solvent indicated in the records of "elbow reserve emergency prescription" of Gehong in the Eastern Jin Dynasty makes artemisinin, an effective antimalarial monomer, stand out.