The strictest in history: what are the big moves the drug administration has put?

In August, I had a dream that I would take a high-temperature holiday, find a place with beautiful scenery and birds singing, and enjoy the quiet summer But for the drug registration industry, it should be the ants on the hot pot now, and the research countermeasures are too much Next, Xiaobian of Yaozhi will sort out this year's daunting moves of the drug administration about the drug registration and approval During this year's two sessions, Wu Zhen, deputy director of the State Food and drug administration, promised to solve the problem of slow drug approval in three years "I'm not satisfied Let's speed up and take some measures In three years, we have digested the stock, balanced the increment, and completed it within the time limit It's really not a verbal commitment this time On Thursday, May 27, while office workers were still grateful for the coming Friday, the latest announcement on the registration fee standard of drugs and medical devices (No 53, 2015) was like a thunderbolt on the ground, waking up people who were looking forward to it CFDA gives the corresponding reasons: the application for registration of drugs and medical devices and the review and approval need to spend a lot of manpower and material resources This part of cost should be paid by the applicant, and it is unfair for all taxpayers to bear this part of cost Considering the social wage level, price rise and other reasons, the charging standard has been seriously low This is not true The registration of new drugs has increased from 35000 yuan to 624000 yuan With such a large increase, many pharmaceutical companies are crying Does the price increase mean to reduce review congestion and improve review speed? This is not a bigger way still to come! On July 22, while everyone was still worried about money, the most cruel announcement of the State Administration of drug administration this year was released - "announcement on self inspection and verification of drug clinical trial data" And it is required to submit the self inspection report before August 25, 2015 (let me be quiet, is there still a place on the roof? Remember to take a seat for me.) In 2006 and 2007, self inspection and self correction and flight inspection were carried out, and all forces were mobilized for centralized review, which set off a "drug supervision storm", and the history was repeated eight years later The self-examination involves 1622 acceptance numbers, 171 imports, 948 new drugs and 503 national standards Among them, there are 1284 acceptance numbers of chemical drugs, accounting for 79.2%, and 236 of traditional Chinese medicine There are 102 acceptance numbers for biological products Whether to withdraw or not is a big problem for enterprises Let's get rid of it After years of hard work, we wasted human, material and financial resources At the same time, we admit that there are problems with our data, which has a great impact on the reputation of the enterprise If we are caught, the consequences will be very serious Long night, how many people began to lose sleep? Less than two weeks after July 31, the announcement (No 140, 2015) on seeking some policy opinions on accelerating the solution of the backlog of drug registration applications came one after another To sum up, there are 16 words: "improve standards, severely punish counterfeiting, speed up examination and approval, and solve the remaining problems" On August 4, the notice on Soliciting Opinions of technical guidelines for pediatric clinical trials was issued The shortage of pediatric drugs has been widely concerned by the society The guidelines are intended to further promote and standardize the clinical trials of pediatric drugs in China and improve the research quality of pediatric clinical trials in China, The research data can fully support the research and development of new pediatric drugs and avoid unnecessary repeated research, so as to better meet the drug demand of pediatric patients On August 5, the notice on further standardizing the acceptance of drug registration was issued again, which put forward corresponding requirements for drug administration and inspectors Think these black and white announcements are over? In 2015, the State Administration of pharmaceutical supervision also made frequent contributions, which never stopped Frequent flying inspection of Chinese herbal pieces, Ginkgo biloba extract, biochemical drugs have been checked, and GMP certificates of many enterprises have been withdrawn On July 16, 2015, in accordance with the relevant provisions of the regulations for the implementation of the drug administration law of the people's Republic of China and the measures for the administration of drug registration, the State Food and Drug Administration decided to cancel 76 drug approval documents such as Cloxacillin Sodium for injection Article 72 of the administrative measures for drug registration (2007 Edition)“ After the application for registration of imported drugs is first approved, if the domestic applicant has been approved for clinical trials, the application may be continued in accordance with the drug registration application and approval procedures If the application meets the requirements, the State Food and drug administration shall approve the application for production; the applicant may also withdraw the application and make a new application for generic drugs The applicant may apply for generic drugs if other applications of the same variety that have been accepted but have not been approved for clinical trials of drugs are returned " On July 30, the application status of acitinib declared by 7 domestic enterprises changed to approved pending certification on July 30 and 31, 2015 According to Article 72 of the measures for the administration of drug registration, it is recommended that the product be returned In the same way, there are varieties such as abitron With the release of the above announcement notice, the whole drug circle is really excited This time, the State Administration of pharmaceutical supervision has made a bold effort to "stabilize, accurately and ruthlessly" all major pharmaceutical enterprises, but it is also an opportunity for transformation It's time for you to calm down and think Note: the intellectual property rights of the above articles belong to yaozhi.com If you need to reprint, please indicate the source and the link of this article.