New drug registration on the market has a "high-speed channel"

After the implementation of the new Drug Administration Law in 2019, the State has issued three documents on the Measures for the Administration of Drug Registration, the Measures for the Supervision and Administration of Drug Production and the Measures for the Supervision and Administration of Drug Operations, which clearly define the whole process and the whole chain management of drugs.
days ago, in order to cooperate with the implementation of the Measures for the Administration of Drug Registration, the State Drug Administration issued three relevant documents for drug review and approval, further improved the regulatory path of accelerated review and approval from the system, and opened three "high-speed channels" for the listing of innovative drugs in China.
this means that China's drug market approval into a new stage, the pharmaceutical market will be further intensified.
in such a situation, pharmaceutical companies need to find their own positioning, according to their own characteristics, deep digging under the advantages of the value of the link, and the pharmaceutical industry chain of each practitioner, should also do their part.
clinical value has become a key "commanding rod" in recent years, in the increasing market competition, drug production management tightening, a number of drugs have voluntarily written off the approval number.
according to incomplete statistics, only in 2018, 2019 two years, the public cancellation of the registration number there are nearly 200 drugs, of which, glucose injection, Annai near the approval of a higher degree of repetition of drugs, is the number of approved to disappear a large number of varieties.
in fact, the problem of low-level repetition has been widely criticized behind China's wide range of drug approvals.
the reason, Youyu blockchain thinking medicine sharing platform co-founder Huang Bing pointed out that there are three main aspects: first, the drug registration declaration excessive duplication, resulting in a large number of zombie approvals, resulting in low utilization rate of pharmaceutical approval;
in order to eliminate low-level drug approvals, China has started the reform of drug review and approval system in 2015, encouraging drug innovation, improving drug quality and optimizing the structure of new drugs are important objectives, including the implementation of consistency evaluation, severe punishment of clinical data fraud, and the revocation of drug approvals with serious adverse reactions.
, on March 30, the General Administration of Market Supervision and Administration published the Measures for the Administration of Drug Registration and the Measures for the Supervision and Administration of Drug Production, which laid the foundation for the rule of law to strengthen the control of drug quality and safety risks, regulate and strengthen drug supervision, and ensure the safety, effectiveness and quality control of drugs.
recently, the official website of the State Drug Administration issued a notice, in line with the implementation of the Measures for the Administration of Drug Registration, the State Drug Administration organization has formulated the "Breakthrough Therapeutic Drug Review Work Procedure (Trial)" "Drug Conditional Approval Application Review and Approval Procedure (Trial)" "Drug Listing License Priority Review and Approval Procedure (Trial)" and will be officially released.
breakthrough therapeutic drug review procedures (trial) mainly encourage the research and creation of drugs with clear clinical advantages. During the
drug clinical trial, the application for the application of breakthrough therapeutic drug procedures shall also meet the following conditions: 1. for the prevention and treatment of serious life-threatening or seriously affecting the quality of life of diseases; 2. For those who do not have effective means of prevention and treatment, the drug can provide effective means of prevention and treatment, or compared with existing treatment methods, the drug has a clear clinical advantage, that is, single use or in combination with one or more other drugs, in one or more clinically significantly improved endpoint.
the Review and Approval Procedure (Trial) for the Application for Approval of Drug Conditional Approval seligible Approvals to encourage clinical value-oriented drug innovation and accelerate the market listing of clinically urgently needed drugs with outstanding clinical value.
a drug that meets the conditions and conditions for approval as specified in the technical guidelines for the approval of the drug conditional approval, the applicant may, during the drug clinical trial, submit an application for conditional approval to the Drug Review Center of the State Drug Administration.
, 1. The medicines urgently needed in public health shall be proposed by the national health department seinided by the relevant departments such as the National Health and Health Administration, and 2. The vaccine urgently needed for a major public health emergency shall be a preventive vaccine for a major public health emergency (Level II) or a particularly major public health emergency (Level I)-related diseases identified in accordance with the Emergency Regulations on Public Health Emergencies, the National Emergency Plan for Public Health Emergencies, etc.
the Priority Review and Approval Procedure (Trial) on Drug Listing Permits to encourage the research and creation of new drugs, and to regulate the priority review and approval of drugs in urgent need of clinical needs. when applying for a
drug listing permit, the following drugs with obvious clinical value may apply the priority review and approval procedure: 1. Clinically urgently needed drugs in short supply, innovative drugs to prevent and treat diseases such as major infectious diseases and rare diseases and improved new drugs;
can be seen from the contents of the three documents, "with obvious clinical value" is the repeated emphasis on the content.
and since the start of the reform of the drug review and approval system, this standard is also the key "stick" to guide the industry to shuffle.
for repeated emphasis on "obvious clinical value" of the significance, Huang Bing pointed out that there are two aspects, first, from the aspect of approval write-off, there are serious allergic reactions, granulocytes lack and other serious adverse reactions, the risk is greater than the benefits, and clinically has alternative drugs, write-off of these approvals;
through these two aspects, to speed up the renewal of existing approvals.
drug review and approval into a new stage of the Three documents issued by the State Drug Administration to clarify the scope of breakthrough treatment drugs, at the same time in the priority review and approval of breakthrough therapeutic drugs, conditional approval of the market-listed drugs into the scope of application and conditions, can be said to be China's innovative drugs on the market registration opened three "high-speed channels", in order to promote the introduction of new drugs to speed up the market, will also accelerate the market shuffling of existing products.
coupled with the new Drug Administration Law, which emphasizes post-marketing evaluation, clear exit mechanism, and the 2020 edition of the Chinese Pharmacopoeia to raise drug standards, it can be foreseen that the process of generic drug elimination will be accelerated, and the pharmaceutical industry will usher in great changes.
Huang Bing said that, in fact, the changes brought about by the policy, as a medical person, have been very clearly felt.
Since the establishment of the State Drug Administration, a series of reform measures have largely eliminated backward production capacity, improved the quality of medicines, curbed drug shortages and other issues.
the future, these changes will continue.
at the same time, retail prices of drugs will continue to rise.
the release of the above three documents, the system has further improved the regulatory path of accelerated review and approval.
, under the New Deal, how can we better encourage drug development and innovation, strengthen the whole process of supervision? Huang Bing pointed out that strengthening the whole life cycle supervision of drugs, for the pharmaceutical industry and pharmaceutical practitioners, is a new subject, can be strengthened from the following three aspects: First, from the system and information above, the establishment of drug safety credit system, the establishment of drug non-clinical safety research institutions, drug clinical trial institutions, drug safety credit files, record licensing, daily The results of supervision and inspection, illegal acts, etc., and timely disclosure to the society according to law; second, from the establishment of a sound professional, professional inspectors, strengthen risk supervision, which is essential in the regulatory process, because someone is to be, and third, to build a public opinion system in which the whole society participates, so that the credit and reputation of each enterprise becomes its life.
to tell the truth, before the drug whole process of supervision, the policy did not mention much, until the new Drug Administration Law came out, the whole process of drug supervision has become a more important link, therefore, in this regard to do more exploration and try.
in fact, the Three documents issued by the State Drug Administration are all supporting documents for the new Measures for the Administration of Drug Registration, which came into effect on July 1.
from the new "Drug Registration Management Measures" to the establishment of breakthrough treatment drugs, conditional approval, priority review and approval, special approval of the four accelerated channels, to the "breakthrough treatment drugs" "conditional approval" "priority review and approval" "special approval" policy refinement, which reflects the determination of China's relevant functional departments to reform, as well as the drug review and approval system reform in-depth progress, from the drug research and development, production, marketing, and improve the level of drug research and development, market-oriented.
this will have a very far-reaching impact on the pharmaceutical industry.
in the past, many of China's pharmaceutical enterprises are research and development production and sales of one-stop, integrated, and now the pharmaceutical industry is divided between the various links, separate management.
affected by policy changes, pharmaceutical companies should later go to their respective advantages in the direction of strength.
in general, China's drug market approval has entered a new stage, combined with the volume of procurement and other policies to speed up the landing, the whole life cycle, the establishment of the whole process of supervision model, the 2020 edition of the Chinese Pharmacopoeia on the improvement of drug quality standards, as well as medical insurance refused to pay for "safe non-drug" and so on, the pharmaceutical market reshuffle will be further intensified.
under such a situation, how should pharmaceutical companies do a good job of market and product strategic layout? Huang Bing gave advice.
he said that pharmaceutical companies need to find their own positioning, according to their own characteristics, deep-dive under the advantages of the link of value.
for example, research and development-driven enterprises, increase investment in research and development, clinical and market-oriented, promote the continuous optimization of China's drug structure, marketing-driven enterprises, combined with the Internet, blockchain and other ideas and concepts of the times, to promote more excellent drugs to the hands of terminals and patients.
in a word, every practitioner of the pharmaceutical industry chain should do their part.
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