Original title: Pharmaceutical companies win big days on the third last day
Radical orientation and policy deviation causes the industry to rush to the ground, lose direction, and evaluate the consistency of the drug giving poor results.
Reporter Caijing He Tao |
"Many people can sleep well tonight," said one pharmaceutical industry player after hearing that the evaluation limit for drug consistency was canceled.
On the evening of December 28, the State Drug Administration issued an announcement that the deadline for evaluation should not be uniformly assigned to varieties included in the list of national essential medicines.
Within the next three days, this is the limit of 289 generic drugs in the National Essential Medicines List (hereinafter referred to as "Catalog 289").
These are drug quality requirements in the National Medicines Five Year Safety Plan 12, that is, the state requires that generic drugs be consistent with the quality and efficacy of the original drug. The State Food and Drug Administration requested that 289 generic drugs must complete a consistency evaluation before the end of 2018. Those who have not completed it will be registered, involving 17,740 approval points and more than 1,800 companies.
Today, big limits have become big, and many generic drug companies are relieved, but for most drug users, this may not be good news.
In the past three years, the evaluation of the consistency of generic drugs has been the work driven by the director of the General Administration of Food and Drug Administration, Bi Jingquan, and is the main priority of the pharmaceutical industry. However, the personal experience of many generic drug companies is that "don't do consistency evaluation and die, do a consistent evaluation to find death." However, the initial intention to improve domestic-produced generic drugs with consistency evaluation has been unanimously recognized by industry and abroad.
Most of the tablets eaten by Chinese are generic drugs produced domestically, it can be seen that the efficacy of generic drugs is closely related to the health of Chinese people. However, the overall quality of domestic generic drugs is uneven, and there are a large number of products that are inefficient or even ineffective. The root cause of the efficacy of generic drugs is directly related to policy orientation.
Before 2000, a shortage of medicines was a major contradiction, the problem of availability and availability of drugs was resolved first. This has led to low evaluation standards for drug regulatory authorities, and a large number of "very water" generics have been released, resulting in low overall quality of Chinese generics.
From 2006 to 2007, after a number of very serious adverse drug reactions in the country, drug safety increased as a top priority, and the pharmaceutical industry entered a period of drug contamination, and the focus on the effectiveness of drugs dropped to a low point.
At the same time, in experiments on generic medicines, data fraud was widespread, and important "bio-equivalence (BE)" tests did not fail for years, creating domestic "myths," and domestic generics also finally slipped into "chasm" where security is not effective.
On July 31, 2015, the former State Food and Drug Supervisory Agency issued "Document No. 140", which cut the problem into the efficacy of generic medicines. For the first time, it was proposed that the conditions for approval of generic drugs to be marketed were to achieve the same quality and efficacy as the original drugs, otherwise they would not be approved.
On March 5, 2016, the General Office of the State Council issued "Opinions on Conducting a Consistent Evaluation of the Evaluation of the Quality and Effectiveness of Generic Drugs", officially launching the launch pistol for the evaluation of the consistency of generic drugs.
It has been difficult to solve problems for years, and it is necessary to solve them in batches. As a result, drugs that meet basic medical needs have become the focus of consistency assessment efforts.
Generic drugs classified in "Catalog 289" have been approved for registration before October 1, 2007, and are also the areas most severely affected by efficacy.
The original policy of the State Food and Drug Administration was to encourage the first to come first served, that is, when more than three production companies passed the consistency evaluation of the same drug variety, varieties that failed consistency evaluation were no longer selected in centralized drug procurement .
Evaluation of the consistency of generic drugs requires that domestic generic drugs achieve the same level of quality and efficacy as original research drugs, so that people can consume safe and effective generic drugs. As a result, doctors also have the potential to open generic drugs in clinics, which can promote the replacement of imported drugs and save medical costs, for industry, can also increase the level of overall development of the pharmaceutical industry.
Steps that are equally beneficial in country design, people's benefits, and a profitable industry, what kind of transcripts have been harvested after three years of implementation?
Statistics from the Food and Drug Administration show that by the end of November 2018, 90 of the "289 catalogs" of the related varieties had been completed.
This amount is far from the intended target. In addition, the Lilac Garden Insight database provides other data to worry about: there are 186 varieties in the "Catalog 289", and there are no varieties proposed by additional application companies, and that is considered an endangered variety.
For a large number of endangered species, Zhuo Yongqing, a researcher at the Tsinghua University Law School Health Research Center, told Caijing reporters that many of them were old medicines with low economic value. They are difficult to produce good economic returns, and producers do not have the motivation to conduct consistent evaluations.
In the official interpretation of the State Food and Drug Administration, it was also stated that among the basic medicinal varieties, about 180 varieties were inexpensive drugs, such as dapsone tablets, dexamethasone tablets, bracts, etc., some of which were clinically needed. The market lacks medicine.
The absence of these drugs can jeopardize the accessibility of essential medicines and the basic needs of drug use publicly. This is also an important consideration for the appropriate adjustment of the consistency evaluation policy.
Moderators underestimate the difficulty and complexity of evaluating the consistency of generic drugs, and optimistically shout out the 2018 deadline, but preparation is not enough.
Need to make a top design
Evaluation of the consistency of generic drugs is technical activity, but several policies and relevant technical documents issued by the General Administration of the Food and Drug Administration have exposed insufficient reserves. In other words, after the target is determined, the top-level design of the consistency evaluation work is not done well.
The most obvious case is the choice of reference reagents, namely determining the benchmark, which is also the main first step in evaluating generic consistency.
However, the Food and Drug Administration of the Food and Drug Administration has not announced the preparation of the referral, and once it falls into the company to submit preparation references chosen by the company. If no advice is given in 60 days, the company can start working according to the type of record.
As a result, "the referee makes an order, the athlete starts running, but doesn't know where to run." This situation makes it impossible to advance work, and the company has a strong wait-and-see attitude.
Compliant companies may be more hurt. In April 2017, after the original Food and Drug Administration announced a catalog of general reference preparations, 43 pharmaceutical companies producing azithromycin fell into collective panic, and they all chose the wrong reference preparation. The consequence of the wrong bet is that the previous work must be restored. In terms of cost and time, it has caused huge waste.
Another widely ordered recipe for reference reagents is that the original drug, which was produced in China, is an original drug that cannot be used as reference preparation. Companies can only go to expensive places around the world to buy the country's original research drugs, which spend a lot of time and financial resources, and seriously delay the progress of work.
Organizations that have worked have also changed several times. Initially, the General Administration of the Food and Drug Administration submitted conformity evaluations to the subordinate units of the Chinese Food and Drug Administration Institute for independent enterprises; The last Pharmacopoeia Committee participated in the formation of reference preparation, and reference preparation was released one by one, in mid-2017, work submitted to the Drug Evaluation Center (CDE) took over and was only on the right track. At the end of 2017, regulations will be adjusted, and original drugs can be applied as reference preparation.
However, two years have passed, and many generic drug companies have gone a long way. It is also an impossible task to complete a "289 catalog" consistency evaluation on schedule.
Li Tianquan, one of the founders of Yaozhi.com, believes that "consistency evaluation does not anticipate that technical problems are too complicated, and they are groping for that time. Most of the time has passed, and policies are still being issued."
There are also consistent evaluation costs for the company. When everyone concentrates on the test, a swarm of bioequivalence tests causes several price increases, which are now the most expensive in the world. In this case, because of the tight clinical resources, they have to wait in line. Miserable business and complaining.
On the occasion of boundary cancellation, the State Food and Drug Administration also provided an explanation. Work on consistency evaluation is the overall progress of China, and faces many challenges such as improving scientific cognition, choosing reference preparation, determining evaluation methods, and insufficient clinical testing resources. . Technical problems found in them need to be evaluated scientifically and completed in stages.
Fortunately, this adjustment is mainly in time. Generic drugs must eventually pass a consistency assessment.
According to the new regulation, generic drugs containing varieties of basic drugs are approved before the application of the new chemical registration classification, after the first variety has passed the consistency evaluation, the same varieties from other pharmaceutical producers in principle must complete consistency within 3 years. Evaluation. If the company fails to complete the application within the time limit and is deemed necessary clinically and has a market shortage, the company can submit an evaluation request that is deferred to the local provincial drug regulatory authority. . If it is not completed within the time limit, it will not be re-registered.
Even though the goals are good, radical orientation and policies can make the industry rush, but get lost, take the road and spend money.
At present, the Food and Drug Administration emphasizes the interpretation that time is below quality. This is corrective and updated.