Some questions on the review of domestic first generic drugs 20

According to the Opinions of the General Administration on Solving the Backlog of Drug Registration Applications and Implementing Priority Review and Approval (Food and Drug Administration Yao Hua Guan [2016] No. 19), our center organized experts to review and demonstrate the drug registration applications applying for priority review, and the drug registration applications and their applicants to be reviewed on a priority basis are now publicized for a period of 5 days.

Innovation brings value. The core of the medical device approval reform is to encourage innovation. From the Health and Family Planning Commission, the Food and Drug Administration, the Ministry of Science and Technology, the Ministry of Industry and Information Technology, etc., are giving medical innovation support from different perspectives, such as the selection of excellent domestic medical equipment by the Health and Family Planning Commission, the special approval of innovative medical devices by the Food and Drug Administration, the medical device science and technology innovation support of the Ministry of Science and Technology, and the "Industry 2015 Plan" of the Ministry of Industry and Information Technology will include medical device innovation in key support areas.

The Red Sea tide has arrived. Due to the decentralization of part of the approval authority to the provincial bureau, the requirements and conditions of the provinces in the approval process can not be exactly the same, the approval has become easier, the final result is that the product registration certificate has become more, some medical device categories have become the red sea, marketing has become the main means of enterprise shopping, with the fierce competition, product profit margins are further compressed. Weak companies will go out of business.

Channels become kings. Medical device distributors with channels, in the context of simpler registration, will continue to bypass the manufacturer to register directly, and then entrust production and processing, realize the integration of production and marketing, and finally win with good channel advantages.

There is a potential increase in registration infringements. Due to the decentralization to the provincial bureau, some unscrupulous businessmen tear off the product packaging of competitors, take it to other provinces for registration, and make some adjustments and modifications during the delivery of samples, and finally become their own products, which will eventually lead to an increase in intellectual property disputes.

The Chinese are not people they think, because it was developed by others.

The Food and Drug Administration, because the company violated the law to impose a fine.

If the enterprise believes that the fine is too high, it can file an administrative reconsideration or administrative lawsuit with evidence.

Even if there is a small amount of investment every year, 20 years is enough time to complete the technological transformation.

Now that you can't afford it, it's better to go out of business.

The main policy is that the Center for Drug Evaluation (CDE) will give priority to the review of innovative varieties of medicines for children.

At present, one of the longest stagnant steps in China's drug R&D cycle is drug review. Due to a large number of generic drug declarations in previous years and the first generic drug declarations that have been included in the new drug system, especially the repeated declarations of varieties that have been saturated in the market, and the multi-specification declarations without market research, the work pressure of the review department is heavy, and the declarations of many drugs are backlogged, and the review cycle has reached several years or even more than ten years. This is a loss for enterprises, R&D units, and the country.

Some drugs for rare diseases, HIV/AIDS, and children's drugs that are in short supply in clinical use are also backlogged for a long time and cannot be approved and cannot be put on the market. In response to this situation, the State Food and Drug Administration has issued a series of relevant policies to open a green channel for these clinical use shortages, especially new drugs and children's drugs, to accelerate the review progress of these drugs, so that they can obtain production licenses and put them on the market within the normal cycle.

On March 23, it was learned at the National Drug Registration Management Work Conference that the efficiency of drug registration review in 2016 was significantly improved, and the backlog of drug review dropped from nearly 10,000 at the peak in September 2015 to 8,200, basically eliminating the registration backlog.

The registration applications of traditional Chinese medicine and ethnic medicines have been reviewed within the time limit, and the clinical trial applications for chemical drugs and vaccines have been basically reviewed within the time limit. We are confident that we will achieve the approval within the prescribed time limit by 2018. Wu Zhen, deputy director of the State Food and Drug Administration, said.

The review of drugs urgently needed in clinical practice has been significantly accelerated, and the public's sense of access to the reform of the drug review and approval system has been greatly improved. Among them, a number of innovative drugs and first generic drugs to deal with serious public health problems and major difficult diseases, such as 13-valent pneumococcal conjugate vaccine, benaglutide injection, tenofovir disoproxil fumarate, and bedaquiline fumarate, have entered the market through priority review and approval. At the same time, the variety application structure has been significantly optimized, taking chemical drugs as an example, the review of new drug clinical application (IND) and new drug marketing application (NDA) completed in 2016 increased by 37% and 81% respectively compared with 2015.

In 2017, the State Food and Drug Administration will further optimize the drug review and approval process, further improve the efficiency and level of review and approval, and meet the current innovation needs of the pharmaceutical industry.