Safe medication, healthy medication! Food and Drug Administration this propaganda film shock hit


Release time:

2018-11-13

Let the common people use new drugs, can afford good drugs, a sweeping the entire pharmaceutical industry of drug medical device review and approval system reform has opened the curtain ...... November 12, the State Drug Administration released the "2018 National Safe Medication Month Promotional". Combined with the theme of "safe drug use and shared health", the propaganda film combed and summarized the fruitful achievements in the field of drug and medical device safety since the 40th anniversary of reform and opening up.

According to the summary of the propaganda film, the achievements made in the field of drug and medical device safety include: the progress of generic drug consistency evaluation has been promoted, the approval speed of imported drugs has reached new highs, and the application for clinical trials has been changed from express licensing system to implied licensing system at the same time; The backlog of drug registration applications has been basically solved, a professional team of inspectors has been initially formed, and the pilot work of the drug marketing license holder system is progressing smoothly.

In addition, the drug regulatory department was elected as a member of the Management Committee of the International Technical Coordination Committee for the Registration of Medicines for Human Use (ICH), participated in the International Medical Device Regulators Forum (IMDRF), and actively participated in the formulation and revision of international rules and standards for medical devices. it has promoted the integration of drugs and medical devices in China with international standards.

  "One day at a time" to the point where you can afford "life-saving drugs"

Aunt Li, 59, from Jinan, Shandong, is most concerned about the price of "life-saving drugs. Four years ago, she was ill, advanced lung cancer, a year ago was found to have brain metastases. The doctor suggested using targeted drug gefitinib tablets for treatment, but there is no alternative drug in China, and the price per box of imported drugs is as high as 5000 yuan. "The first hand is 40 thousands or 50 thousands and 50 thousands or 60 thousands. Where can the rural people get it? There is no way. They can only live day by day. "For patients who cannot afford imported drugs, high-priced drugs deprive them of the hope of living.

In February 2017, a domestic pharmaceutical company's generic gefitinib tablets went on sale, each box is less than 1/3 of the import price. "Patients like Aunt Li who can't afford imported drugs have the hope of living."

Sun Yan, chief physician of the Department of Radiotherapy at Peking University Cancer Hospital, said: "After using generic drugs, and medical insurance can be partially reported, 1000 or 2000 yuan will come down in a month."

The propaganda film pointed out that the most fundamental way to make people affordable for life-saving drugs is to develop alternative drugs that are consistent with patented drugs in terms of quality and efficacy as soon as possible. Therefore, China, the United States, Japan and many other countries are vigorously developing generic drugs.

 Life-saving drugs to the original research drug "0" gap

Why should drugs developed by others be imitated? Why should they be imitated? Sun Yan, chief physician of radiotherapy department of Peking University Cancer Hospital, explained that there is a protection period after the original research drugs are put on the market, during which imitation is not allowed. The imitation outside the protection period can realize the patient's medication in the shortest time.

According to the promotional film, there are nearly 5000 pharmaceutical companies in my country, 99% of which are generic drug companies; more than 95% of the nearly 170000 drug approvals are generic drugs.

"However, it is embarrassing that the standards for research and approval of drugs approved for marketing in the past are low. As a result, some drugs have some gaps in efficacy with the original drugs. "In response to this shortcoming, on August 18, 2015, the State Council issued the" Opinions on Reforming the Review and Approval System for Drugs and Medical Devices ", which will improve the quality of generic drugs and accelerate the consistency evaluation of generic drugs as a drug review and approval system. One of the five major goals of the reform. Clear in accordance with the quality and efficacy of the original drug standards. Consistency evaluation of generic drugs already on the market.

The purpose of the reform is self-evident, is to let the people can eat safe and reliable generic drugs.

Shi Lu Wen, director of the Department of Pharmacy Management and Clinical Pharmacy, School of Pharmacy, Peking University, said that if people's sense of gain is enhanced, accessibility will be improved. In addition, strengthening the innovation of generic drugs is also conducive to the development of the industry.

 "Increase the likelihood of survival"

The propaganda film said that making people use and affordable high-quality generic drugs and reducing the burden on patients is one aspect of improving the safety and accessibility of drug use by the public; on the other hand, it is also very important to speed up the listing of new drugs and innovative medical devices at home and abroad as soon as possible, especially for some critically ill patients, using new drugs and medical devices listed at home and abroad as soon as possible may mean increasing the possibility of survival.

On October 8, 2017, the Central Office and the State Council jointly issued the Opinions on Deepening the Reform of the Review and Approval System to Encourage Innovation in Drugs and Medical Devices. According to the deployment of the Party Central Committee and the State Council, the national drug regulatory department will take new drugs and medical devices as well as medical urgent needs. Market shortage of medical equipment varieties will be limited into the scope of review and approval, as soon as possible to let domestic and foreign innovative drugs and medical devices used in patients.

"In children's medicine, for example, some rare diseases such as atypical hemolytic uremic syndrome. In the absence of good drugs in China, in order to reduce the probability of death, can such products be directly incorporated into the Chinese market with overseas data. "Zou Limin, reviewer of the Clinical Department of Drug Evaluation Center, said that the time gap between many of our innovative drugs and overseas listing is getting shorter and shorter.

Simplify the approval process for new drugs and medical devices listed overseas, receive data from overseas clinical trials, optimize the approval process for clinical trials of pharmaceutical devices, and a series of reform measures have given priority to a number of innovative pharmaceutical devices and clinically urgently needed varieties. Huang Qingzhu, director of the chemical drug project in the business management office of the drug evaluation center, said: "the heads of the various specialties involved will review and complete the review as soon as possible, so as to ensure that the innovative drugs can be supplied to the market and patients as soon as possible."

Shen Chenyang, deputy director of the Vascular Surgery Center of Fuwai Hospital, said that through the adjustment of this national policy, all processes are changing, and they are actively innovating for doctors and providing various conveniences for the research and development of medical devices. Once approved, it will soon be used clinically. For example: some artificial heart used by cardiac surgeons, or some valves, or some electrophysiological pacing of some things.

The promotional film shows that as of the end of June 2018, there were 29 batches of 597 drug registration applications for priority review and approval. In September 2018, 49 innovative medical devices and 5 priority medical device products were approved.

While encouraging innovation in pharmaceutical equipment, the drug regulatory authorities have deepened the reform of the release and management services, optimized the review and approval process, and improved the efficiency of review and approval. The number of drug registration applications to be reviewed decreased from 22000 at the peak of the backlog in 2015 to less than 3200.

Guan Kailin, deputy dean of the Pharmaceutical Research Institute of a pharmaceutical company, introduced that in the five years from 2012 to 2017, the pharmaceutical company has obtained production approvals for less than 10 varieties. 2018 is the beginning of this year, from January to now, six products have been approved for production.