News in the pharmaceutical industry has never stopped, grabbing many eyeballs, but there are some special circumstances:
- Less conspicuous, but tricky; It does not directly cause adverse consequences but is related to public life and health; It does not necessarily attract public attention, but it is indeed something that professionals in the medical industry must pay attention to…
For example, drugs are out of stock, cheap drugs are out of production, quality problems of domestic generic drugs, and new drugs are on the market too late and too late.
So on these issues, Clove Garden has done some what to solve them?
Is there a shortage of drugs?
At the beginning of this year, after the stock of Youjiale (levothyroxine sodium tablets) was out of stock, it caused anxiety among patients with thyroid diseases. Everyone was speculating about why the stock was out of stock, especially for patients. The anxiety of [drug withdrawal] left many patients at a loss.
At this time, if doctors, clinics and hospital managers can quickly grasp the situation, find alternative drugs or find other manufacturers, the problem will become relatively simple.
The Clove Garden Insight (China Pharma Data) Pharmaceutical Database is such an information channel. We can preliminarily confirm the reasons for drug shortage and alternatives through information inquiry.
In addition, as doctors and medical-related practitioners, it is also very important to update or inquire about the following information at any time:
1. Has the drug approval number expired?
At the beginning of 2014, Baiduobang (mupirocin ointment) was out of stock without warning. Clove Garden organized a survey. More than 10% of hospitals were out of stock but the reason was not clear.
After that, I inquired the Insight database and found that when the original shortage occurred, the validity period of the import registration certificate of more than 100 states had expired for more than half a year.
Not only that, Insight database showed that SmithKline’s new application for registration in Baibang was still in line for review at that time. It was not until September 2015 that Baibang was approved for re-registration. In other words, Baibang [drug shortage] lasted for two full years.
2. What other enterprises are producing?
After Youjiale was out of stock at the beginning of the year, public anxiety immediately spread. In fact, although Youjiale is the first choice of medicine, there are also alternatives to choose from.
The question is, how do you find alternatives?
Insight’s listed drug database keeps pace with the drug listing data on CFDA’s official website, and can also directly judge the status of the drug approval number, that is, whether the number is valid and whether the enterprise is still in production.
Through this tool, we quickly found 21 manufacturers with valid approval documents for levothyroxine sodium tablets and thyroid tablets.
In addition, cheap life-saving drugs that have been rumored to be discontinued can also be confirmed through Insight database to see if these drugs are really discontinued.
Is the drug on the market slow?
Since 2003, only 24 innovative Class 1.1 new drugs have been approved for listing in China, which shows that China’s innovative drugs are still on the way. The treatment of many major diseases such as tumors and AIDS depends on the import of original research drugs from foreign-funded enterprises.
However, the marketing of drugs is a very complicated and long-term matter. In order to ensure that medicines are safe and effective, After application for clinical trial, application for clinical trial, application for listing and approval, In addition to this process of long administrative review and approval time, the import of new drugs in China is generally later than the drug in Europe and the United States on the market time. This is a long-term problem that has troubled Chinese doctors, pharmaceutical companies, the government and the public.
In this regard, the country has not done nothing. Starting from 2015, The State Council and the State Administration have issued a series of policies to improve the slow speed of drug review and the late listing of original research drugs, including [Guidelines for International Multicenter Clinical Trials], [Accelerating the Resolution of Historical Backlog Review], [Priority Review and Approval], etc. At this time, both multinational pharmaceutical enterprises and domestic-funded enterprises will naturally be more concerned about the progress of drug registration.
In the past, enterprises could only check the queue number of the drug application acceptance number on the website of the National Drug Evaluation Center, and then calculate the approximate date of possible approval according to other queue numbers.
Now, Insight database integrates official data resources, and can quickly calculate the average review time of similar acceptance numbers for enterprises. In addition, pharmaceutical companies no longer need to log in every day to stare at the dynamic changes of acceptance numbers, but only need to subscribe to related drugs, and the dynamics of registration declaration will be automatically pushed.
In this way, an efficient working method can enable enterprises to judge the progress and trend of drug registration more rationally during periods of policy turmoil, thus developing drugs more rationally.
We help generic drug companies improve the quality of drugs.
Last year, we paid to reprint an article by a teacher of Tumo < < What is the poor quality of domestic drugs? > >, the article analyzes the research and development process of domestic generic drugs in great detail and professionally, and the biggest problem with the quality of domestic drugs is that they are safe but ineffective.
Both the state and the industry are aware of these problems, which is why the State Food and Drug Administration has started to vigorously carry out the consistency evaluation of generic drugs this year. The first is the generic drugs in the list of essential drugs that are most directly related to the public, requiring the consistency evaluation to be completed by the end of 2018.
The generic consistency evaluation has just begun, Full of doubts and difficulties, the whole country is looking for available data and exploring feasible methods. However, the deadline for completing the evaluation before the end of 2018 and the favorable market policies after completing the evaluation have made enterprises become ants on the hot bricks for a while, and as long as they see the words “consistency evaluation”, they will jump up.
The Insight database first uses accurate data to screen and match the drug approval numbers and enterprises that need to do consistency evaluation according to national regulations. Secondly, we have specially built an integrated generic drug consistency evaluation comprehensive inquiry system for enterprises. Pharmaceutical enterprises can quickly inquire about the listing data of Europe, the United States and Japan, the reference preparations of the United States and Japan and the BCS classification of drugs.
We know very well that although the generic drug consistency evaluation work has been widely fired, the current situation is a snail’s pace. Without a solid industry data base, this evaluation work related to the quality of generic drugs in China is just looking at flowers in the fog and looking at the moon in the water.
We are committed to helping the development of pharmaceutical enterprises.
Drugs are out of stock, cheap drugs are out of production, new drugs are on the market too late and too late, quality problems of domestic generic drugs, etc. These are just a few of the problems in the pharmaceutical industry, There are more issues related to the development of pharmaceutical companies, For example, how to set up a project to research and develop drugs, whether to infringe patents, how to know the progress of competitors’ drugs, how to analyze and evaluate the value of pharmaceutical enterprises to make decisions on enterprise acquisition and investment, The Clove Garden Insight database is looking forward to helping the enterprise, thus finally bringing into reality the good wishes of the enterprise to rationally develop drugs, reduce the cost of medication for patients and increase the choice of medication for doctors.
For this reason, Insight Database has been working hard to temper and integrate over and over again on the basis of accumulating ten years of data, only to provide the most convenient and efficient working method for pharmaceutical enterprises.
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Photo Source: Station Cool Hailuo Creative