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The Changchun Changsheng vaccine incident is one of the top ten buzzwords in 201
On July 15, 2018, the inspection team of the State Drug Administration found that Changchun Changsheng had serious violations of the "Good Manufacturing Practice for Drugs" (GMP) in the production process of freeze-dried human rabies vacci.
Public opinion quickly fermented, and General Secretary Xi Jinping, who was visiting abroad, gave important instructio.
Soon, 18 suspects including Gao Moufang, chairman of Changchun Changsheng Biotechnology .
Wu Zhen, however, was not the highest-ranking official to be disciplined over the vaccine incide.
Bi Jingquan (Secretary of the Party Leadership Group and Deputy Director General of the State Administration for Market Regulation, and former Director General of the State Food and Drug Administration from February 2015 to March 2018) took the blame and resign.
Bi Jingquan (Secretary of the Party Leadership Group and Deputy Director General of the State Administration for Market Regulation, and former Director General of the State Food and Drug Administration from February 2015 to March 2018) took the blame and resign.
This is somewhat comforting for the pharmaceutical industry, which is full of expectations, but this addition, similar to the provincial and ministerial-level officials who will continue to perform their duties at the National People's Congress or the National Committee of the Chinese People's Political Consultative Conference after leaving office, is considered a "second-tie.
Expose medical information to the sun
Expose medical information to the sunBi Jingquan's speech this time is about the national electronic medical record syst.
Bi Jingquan believes that technology, data, and residents' privacy are all solvable proble.
The real difficulty lies in breaking the compensation mechanism that medical institutions use to support doctors and rationalizing the price of medical servic.
The implementation of the electronic medical record system can realize the intercommunication of medical information by implementing a unified medical information level, and intercommunication and unification are the premise of national refo.
The implementation of the electronic medical record system exposes all medical information to the sun , what is the condition of the patient, what measures the doctor has taken, whether the charging method is reasonable, and whether it deviates too much from the standard diagnosis and treatment and payment methods, all of which are well document.
Implement an electronic medical record system to expose all medical information to the sun
At the same time, the Internet-wide interconnection of electronic medical records will have real-time and regular supervision functio.
From the perspective of benefiting patients, clinics and medical insurance funds, the implementation of the electronic medical record system is on the li.
On May 12, the national unified medical insurance information platform was announced to be basically complet.
Therefore, in order to promote the electronic medical record system, doctors must have a reasonable inco.
Therefore, in order to promote the electronic medical record system, doctors must have a reasonable inco.
The State Council has made it clear in the medical reform plan that the compensation of public hospitals will be gradually changed to "two channels of service charges and financial subsidie.
In September 2021, eight departments including the National Medical Insurance Administration issued the "Pilot Plan for Deepening the Reform of Medical Service Prices" to promote Sanming's experience in implementing the reform of the annual salary system for docto.
The reform of the doctor's sunshine income will become the vanguard of the electronic medical record syst.
Bi Jingquan believes that the principle of "total control and structural adjustment" must be adhered to and not increase the burden of social medical expens.
Biju's speech is aimed at the next trend in the pharmaceutical industry, which can not help but remind people of the stormy 201
Drug review reform, meritorious in the future
Drug review reform, meritorious in the future Before 2015, it was a pile of bad debts left by Zheng Xiaoyu, who "did not dream of the endin.
The drug regulatory department is too conscientious and the approval efficiency is extremely sl.
From 2007 to 2009, basically no new drugs were approv.
From 2009 to 2013, a total of 2,663 domestic drug registration numbers were approved in the five years, which only accounted for the total number of the above-mentioned drugs in the market at that ti.
less than
Innovative drugs and good drugs missed the patent protection period in the hard line, which seriously affected the enthusiasm for new drug research and developme.
It's hard to imagine that this nearly stagnant drug approval has lasted for a deca.
Until January 2015, Bi Jingquan served as the director of the State Food and Drug Administration, and began a drastic refo.
The first is the "July 22 Massacr.
On July 22, 2015, the State Food and Drug Administration (CFDA) issued the "Announcement on Carrying out Self-Inspection and Verification of Drug Clinical Trial Data", which is known as "the most stringent data verification requirements in histor.
The announcement requires 1,622 clinical trial projects to self-examine and withdraw if there are any proble.
If the report is not submitted or withdrawn within the specified time, the General Administration will conduct an unannounced inspecti.
Once the problem is found, "the application will not be accepted within 3 years", "the qualification of the drug clinical trial institution will be revoked", and "blackliste.
For the clinical trial verification alone, the Food and Drug Administration soon issued 26 more announcemen.
Under high pressure, clinical trial projects are like falling domino.
About 80% of the 1,622 registration applications were withdrawn voluntarily, and 30 were reject.
11 institutions were put on file for investigation, and those suspected of committing crimes were handed over to the public security orga.
The problems are listed one by one: the control drug is untrue, the test drug is untrue, the bioequivalence test is fraudulent, and the data modification, omission or failure to report serious adverse events in the phase II and III clinical trials are fou.
There is an uproar in the industry, but it is reasonab.
There are many criticisms accumulated in drug research and development and approval, but no one has ever managed .
"July 22" is just an appetiz.
A month later, the pharmaceutical industry ushered in the biggest change in the past deca.
On August 18, 2015, the "Opinions of the State Council on Reforming the Review and Approval System for Drugs and Medical Devices" (Guo Fa (2015) .
44) was releas.
44) was releas.
There is no nonsense in this heavy document of about 4,000 words, "solving the backlog of registration applications", "improving the quality of generic drugs", "encouraging research and creation of new drugs", "improving the quality and transparency of review and approva.
The five reform goals have pinpointed the shortcomings of the past and the direction of future development, and have carefully planned the development blueprint of the pharmaceutical indust.
The opinions pointed out that the main tasks of the reform include adjusting the scope of new drugs, promoting the consistency evaluation of generic drugs, implementing special review and approval for innovative drugs, developing a drug marketing license holder system, and improving clinical trial approva.
The major moves of the industry are all the product or extension of Document .
4
Bi Ju led the Drug Evaluation Center to reshape the pharmaceutical industry like a sto.
As of the end of 2016, in just 16 months, the CFDA has successively issued about 200 policy documents, dizzying the indust.
The reforms have achieved impressive resul.
On January 12, 2017, the China Food and Drug Administration announced that the current backlog of drug registration applications in China has dropped from nearly 22,000 at the peak in 2015 to 8,863 at the end of 2016; applications for clinical trials of chemical drugs and vaccines, various types of traditional Chinese medicine and ethnic medicin.
The registration application has been reviewed on time; 146 innovative drugs with obvious clinical value, urgently needed drugs, expired patent drugs and first domestic generic drugs have been given priority revi.
This was only in the past, and now the pharmaceutical industry is booming, foreign R&D talents are rushing to return to China, Biotech has sprung up like mushrooms after a rain, innovative drugs are increasing year by year, high-quality and cheap generic drugs, a series of chain reactions are inseparable from the rebirth of the drug evaluation cent.
refo.
"Thousands of gold are easy to get, but good generals are hard to find", as the soul of the drug trial reform in that year, Bi Jingquan's return is a popular expectati.
In fact, rather than saying that everyone loves Bi Jingquan, it is better to say that we all love and look forward to a better tomorrow for the pharmaceutical industry!
