2015-11-16 14:42

 

Drug review speed generic drugs will enter the fast lane

 

[direct network November 16th] (first financial daily) the country's 18597 years of the backlog of new drugs are under unprecedented strict access to wait for approval.
After the introduction of the policy, in November 12th, the State Food and Drug Administration (CFDA) issued a number of policies on drug registration review approval, and the implementation of the day.
To improve the approval of generic drugs, optimize the clinical trial application for review and approval, the implementation of the same varieties focus, strict review of the safety and effectiveness of drugs, to speed up the clinical needs and other drug approval, punish clinical trial data fraud behavior and other ten were made detailed provisions.
"Included in the list of varieties, where there is evidence to prove the efficacy of the drug is not exact, adverse reaction, or other causes harm to human health and immediately cancel the registered number of approval for drugs. Production enterprises should promptly carry out related products re evaluation, and in three years to submit evaluation results; fails to submit or not through the re evaluation, cancel the drug approval number. The application for registration of a copy of the above varieties shall not be accepted." Li Maozhong, deputy director of the food and Drug Administration of drug registration division, special emphasis.
As a series of supporting documents in the year of drug concentration review, at this time, the introduction of this provision, it is with the drug trial work must be a move.
The slow registration of new drugs in our country is not only a historical problem, but also a challenge to the present work of drug administration. How close to 10000 new drug registration applications, coupled with the history of the backlog of nearly 20000 of the situation, through the preparation of an increase of 100 people do not release the lack of completion, it seems to be an impossible task.
Food and Drug Administration announced the 2014 annual report of drug review shows: in 2014, the national food and Drug Administration of the drug review center completed 5261 of the technical review of drug registration application, compared with 2013, the amount of the review completed 12.9%.
But even so, pending tasks backlog is still 18597, this figure compared with 2013 pending the total task has increased by 4362.
2015 two sessions, the National People's Congress on behalf of the Chinese people's Political Consultative Conference, the food and drug administration, deputy director Wu Zhen made it clear that will pass the three year time to achieve dynamic review, to solve the problem of slow assessment.
"The most prominent contradiction is that we have too few reviewers, the amount of reporting is too large, the amount of annual reporting average in 9000." Food and Drug Administration of drugs and cosmetics registration division Wang Lifeng said during the two sessions.
How to clarify the source of the registration of the channel, so that the rapid development of innovative drugs, so that the declaration of the drill to change the form of a simple change in the packaging of the new drug is rejected, the original drug trial system should be the proper meaning.
From this point of view, the evening of July 31st published "for a number of policy advice to expedite the settlement of the backlog of drug registration notice (2015 No. 140th)" (hereinafter referred to as the "opinions"), requires modifying material for the last time in August 15th; and the July 22nd release of "regarding the development of drug clinical trial data checking and verification work the announcement", the industry called "the 815 Massacre" and "722 Massacre", because it is stressed that the two documents in the registration of new drugs innovation, generics, raise the standard of control by simply changing the way for a new drug dosage form strict measures, will likely lead to a number of new drugs the symbol is not in conformity with the provisions are prodding.
And to concentrate on long-term research and development of new drugs for pharmaceutical companies, improve standards for generics came to be formally put forward, both for innovative drugs or the failure of a large number of patents, foreign multinational enterprises original research varieties like a long-term positive policy guidance.
China Foreign Investment Enterprises Association of drug development and Development Industry Commission (RDPAC) has been for many years on the quality of generic drugs, such as the transmission of sound. 2014 the main factors affecting the quality of drugs, the report said, the country has approved the listing of drugs, there is a significant difference in quality - the low quality of medicine has a huge cost advantage, when the regulatory standards allow the existence of such low quality products, bad money drives out good money, companies often lack the power to enhance the quality.
And the "comment" will improve the generic drug approval standards put in the first place, announced "generics according with the original research quality and curative effect of drug consistent principle to receive and review and approval; has accepted the application for registration of generic drug, the country has approved the original research drug, did not meet with the original research quality and efficacy of the drug consistent disapproval; domestic has not yet approved the original drug research, according to the original standard has approval conditions, enterprise in listed after three years of domestic demand with the original drug research of consistency evaluation, failed when cancellation of drug approval number."
In May 27th, the latest drugs, medical equipment products registration fees and the introduction of the implementation details of the new drug registration fees significantly improved - learn from the experience of foreign mature drug market approval, the adjustment of domestic new drug registration fee standard from the original 624000 rose to 17.8 yuan, 45000 times before this, and imported drugs rose from 969000 to 35000 yuan, is the previous 21.5 times, with a low level of reporting, and speed up approval.
How to do the right thing at the right time, regardless of the enterprise or the regulatory side, are a need to choose and insist on the road, in the fast running to the international level, the reform of the challenges and pains are necessary, but also worth it. 3
(original title: drug review focused on the speed of generic drugs will enter the "serious" fast lane)
Editor: Xiao Qin
Interpretation of the hot news, showing sensitive events, more exclusive analysis, in the direct report network micro channel, scan two-dimensional code free reading.