Original title: Pharmacy companies won the third day on the last day
In this way, the industry led to radical orientation and deviation policies, the loss of direction and the consistency of drug assessments resulted in poor results.
Caijing reporter He Tao |
"Many people can sleep well at night." One pharmaceutical industry said the drug's consistency assessment has been abolished.
On the afternoon of December 28, the State Drug Administration announced that the assessment limit is not included in the varieties included in the list of national medicines to be uniformly established.
In the other three days, the National Essential Drugs List (hereafter "289 catalog") is the 289 drug limit.
12-year National Drug Dependency is the condition of the five-year Drug Quality, that is to say, the state must depend on the quality and efficiency of the original drug by general drugs. Drugs and Food Safety High-level 289 generic drugs should complete coherence assessment by 2018. Those who have not finished will participate in 17,740 homologation numbers and more than 1,800 companies.
Nowadays, large limits are high and many consumers of drugs calm down, but most drug users do not have good news.
Over the last three years, the general consistency of drug assessment was the director of the General Administration of the Food and Drug Administration of Bi Jingquan, and became the priority of the pharmaceutical industry. However, the personal experience of many generic drug companies is "do not do consistent assessment and die, a consistent assessment to find death." However, it has been widely accepted in industry and abroad, in general, the intention to improve general medications based on the usual assessment of medicines.
Most pills that people from China eat are home-made medications. The effectiveness of generic drugs is closely related to Chinese health. However, home generic drugs are of a different quality overall, and there is a large number of effective or even effective products. The cause of effectiveness of generic drugs is directly related to policy orientation.
Before the year 2000, the main contradiction was that of medicines. The availability of medicines and the availability problem was solved first. This has led to a little level of assessment for regulatory authority authorities, and "generic" generic drug is released, resulting in the general quality of Chinese drug genera.
From 2006 to 2007, after some serious adverse drug reactions in the countries of the country, drug safety was a top priority, while the pharmaceutical industry entered the drug impurities and dropped its drug vision.
At the same time, in a generic drug-based experiment, data frauds are widespread and an important "bioequivalence (BE)" test has not failed for many years, creating a "home" myth and generic drug-based households Finally, it slipped into a "cliff" where security was not effective.
As of 31 July 2015, the State Food and Drug Administration General published a "140 document". This reduced the problem to achieve the creation of drugs. For the first time, it is a condition of accepting the generic drug marketed to achieve the quality and effectiveness of the original drug, otherwise it will not be accepted.
On March 5, 2016, the General Office of the State Council published its opinions on "Evaluation of the quality and efficiency of the generic drugs", officially launched to assess the consistency of generic medications.
Many problems have been solved for many years and it is necessary to repair batches. As a result, medicines that meet the basic medical needs have become the focus of the effort to evaluate consistency.
The genetic drugs classified in the "289 Catalog" category have been listed before October 1, 2007 and is an efficiency gap.
The National Institute for Food Safety and Drug Addiction encouraged the first policy, which is to say, when overproduction of three-drug instruments exceeded production companies, the varieties that failed to assess consistency were not selected in centralized drug recruitment.
Assessment of coherence with generic drugs requires that domestic generic drugs achieve the same level of quality and efficacy as the original research medicine for the public to eat safe and efficient food. As a result, doctors may also open up generic medications at the clinic, to replace imported drugs and promote the expense of doctors; For industry, the overall level of development of the pharmaceutical industry can also be improved.
How has the country's design, the benefit of the people and profit industry profitable after the implementation of the three-year implementation of transcription?
The State Food and Drug Administration statistics show that since the end of November 2018, 90 have been completed with "289 catalog" varieties.
This number is targeted. Additionally, the Lilac Garden Insight database provides data on worrying data: "289 catalog" includes 186 varieties, and there are no varieties that the company sends additional applications and is a risky variety.
In the case of many high-precision species, Zhuo Yongqing, a researcher at the Center for Health Research at the Law Faculty at Tsinghua University, told reporters from Caijing, many of whom are an inexpensive low-cost drug. It can bring good economic returns to the difficulties and manufacturers do not have motive for consistent assessment.
It is also mentioned in the official interpretation of the State Food and Drug Administration, and amongst the basic drug varieties, there are 180 variant drugs, such as dapsone pills, dexamethasone pills, bracts, etc. Some of them are clinically necessary. Market is little medication.
The dangers of these drugs endanger the basic needs of the clinic for the use of drugs and drugs. It is also important in terms of adaptation to coherence evaluation policy.
The moderator underestimated the difficulty and complexity of assessing the consistency of generic drugs and cited the 2018 period, but the preparation was not enough.
You have to make the top design
Evaluation of the consistency of generic drugs is a technical activity, but major political and technical documents provided by the General Administration of food and drugs have insufficient reservations. That is, after defining the goal, the higher level of coherence evaluation work is not well done.
The most notable case is the selection of reference reagents, that is, determining the benchmark, which is the first important step in the assessment of generic coherence.
However, Food and Drug Administration Food and Drug Administrations have not announced any preparations for reference, and once the company has undertaken to submit the relevant reference preparations. If there is no advice within 60 days, the company may start work by type of record.
As a result, "the referee made an order, the athlete started running, but he does not know where to run." This situation does not allow the progress of the work and the company is in dire position of hope.
Obedience could be injured. In April 2017, after the original Food and Drug Administration published a catalog of generic referral preparations, 43 single-pharmaceutical pharmaceutical companies that produce azithromycin were selected and selected incorrect reference preparations. The wrong effect is to restore past work. In terms of cost and time, it has caused huge waste.
A widely-used recipe for reactive references is the original drug that can be used as a benchmark for the original drug produced in China. Companies can only go to the highest prices around the world to buy medication against the country of origin, consuming a lot of time and economic resources and detecting important advances in the work.
Work organization has also changed several times. At the beginning, the General Administration of Food and Drug Administration passed the intelligence assessment to the independent subordinate organization of Small Business Food and Drug Administration, the last Pharmacopoeia Commission helped to establish benchmarks, and the reference preparations were published after each other. In the middle of 2017, the Drug Evaluation Center (CDE) was distributed, and was only on the right path. By the end of 2017, the regulations will be adjusted and the original drug may be used as a reference preparation.
However, two years have gone by, and many generic drugs have come a long way. It is impossible to complete the "289 catalog" consistency assessment as scheduled.
Li Tianquan, co-founder of Yaozhi.com, believes that "the consistency assessment has not advanced that technical problems are complex and that they are groping at that time. Over time has passed and policies are still being broadcast".
Similarly, there is also a consistent company cost assessment. Concentrating each one of them, bio-resistance tests led to a rise in prices, which is now the world's most expensive. In this case, due to tight clinical resources, they have to wait online. Businesses are miserable and complain.
When the limit was abolished, the State Food and Drug Administration explained. Coherence evaluation work focuses on China's overall advancement and challenges many challenges, such as improving scientific knowledge, choosing benchmarking, determining evaluation methods, and sufficient clinical testing. . The technical problems that have been identified need to be scientifically evaluated and gradually resolved.
Fortunately, this adjustment is mostly in time. Generics must eventually overcome consistency assessment.
According to the new regulation, after passing the first variants of consistency, the genetic medications approved prior to the classification of first class variants were approved. Likewise, the same variety of other pharmaceutical manufacturers should be consistent for 3 years. evaluation If the company does not apply within a period of time and is considered clinically necessary and is a market shortage, it may request a delayed assessment to the local legislative authorities. After the investigation and approval of the provincial drug departments and the Department of Health Administration, the company can successfully postpone it. . If the time limit is not exceeded, it will not be registered.
Although the goal is good, radical orientation and polarized policies have driven the industry, but they have lost their way, they take the road and spend money.
Currently, the Food and Drug Administration of the State highlights the quality of its interpretation. Correct and renewed.