Inherit For Three Thousand Years

Chapter 494: Special approval

"If I didn't find it, I didn't find it. It's not a long time for half a month. I can wait." Xiao Yao was a little regretful that even the second brother did not find out about Niu Shengtian.

"Little Junior Brother, after Madam Niu transfers to my medical team, I will tell you about her immediately, but there is only so much I can help you. At the level of Niu Zhiguang, the task of healing Madam Niu, I It is impossible to refuse. At most, it is just to find a reason to let her transfer to my medical team later. I have agreed to this matter, and now I can’t regret it. Otherwise, I can at most let her be one late. Turn around the month."

Niu Shengtian dared to threaten his junior brother. Qiu Shangsong was very angry. He wanted to help a little bit more with this matter, but unfortunately there was not much he could do.

Xiao Yao didn’t need the help of the second brother. “In my eyes, Niu Shengtian is just a mortal man with a little power. I want to deal with him easily. As long as the second brother tells me his news in time, things are easy. It can be resolved."

"Brother, the effect of using the Heavenly King Heart Protection Pill is not bad?" Xiao Yao changed the subject.

Qiu Shangsong said excitedly: "The effect is so good! In the past two months, after using Tianwang Huxin Pill in my group, six patients with severe heart disease have completely recovered, and 13 patients with critical heart disease have completely recovered. The condition has been very well controlled. Although it will be difficult to cure in the future, as long as you take Tianwang Buxin Pill for a long time, at least you will not die of heart disease."

"The effect is good. Your medical team is a general treatment team. Heart disease patients are only a small group. I think the clinical effects of other specialty hospitals should be better." During this period, Xiao Yao devoted himself to studying the gods of heaven. I don’t know much about the promotion of Tianwang Huxin Pill.

"Of course, the effect of Tianwang Huxin Pill is so obvious, no matter which hospital it is used in clinical practice, I can't bear to give it up.

My medical team and Xiehe Cardiology Department were the first to use Tianwang Huxin Pill. Because of its obvious effect, Fuwai Cardiovascular, Anzhen Hospital, Zhongshan Hospital, Guangdong Provincial People's Hospital, West China Hospital, etc., ranked the highest in domestic new internal medicine. The strongest cardiology department has also used Tianwang Huxin Pill in clinical practice.

Because the effect after use is too obvious, with the demonstration of these top hospitals, more than 20 tertiary hospitals have begun to use Tianwang Huxin Pill in clinical practice.

Nearly 30 large-scale tertiary hospitals will help you with clinical practice, and all the received so far have been praised, and no side effects have been found. It seems that the time for Tianwang Huxin Pill to market will be greatly shortened. "Qiu Shangsong is very satisfied with the efficacy of Tianwang Huxin Pill.

"Although the efficacy of Tianwang Huxin Pill is very strong, it is impossible to enter 30 third-class hospitals for clinical practice without the personal connections of the brothers. Another day, brothers, if you have time, come to your home. I will prepare something for you. "Xiao Yao has never doubted the prestige of the second brother in the medical field.

It is a miracle that Tianwang Huxin Pill can enter 30 large tertiary hospitals for clinical practice in such a short period of time. Without the full promotion of the second brother Qiu Shangsong, it would be impossible to make such rapid progress.

Qiu Shangsong did not take credit. "The main reason is that Tianwang Huxin Pill is too effective. Such a good drug should be marketed earlier to benefit more patients. You can arrange for your professionals to apply for special approval procedures. I It can also help you work hard, and the approval process should greatly shorten the time."

"Is there a special approval procedure? I haven't dealt with specific matters, so I really don't understand it."

"Of course..."

Next, Qiu Shangsong told Xiao Yao about the relevant information about the special approval procedures.

As an industry related to the national economy and people's livelihood, the development of medicine and the speed of its development directly affect the national health security and quality of life. Among them, the development status of new drug research and development institutions will affect whether my country's national pharmaceutical industry can maintain an independent state of existence in technology. With the promulgation of the state's policy to encourage innovation, and with the technical support of national-level research centers and scientific research institutes, domestic new drug research and development and innovation capabilities continue to increase, providing favorable conditions for domestic new drug research and development.

The "Administrative Measures for Drug Registration" officially promulgated by the State Food and Drug Administration clearly proposes special approval procedures for new drug review.

The new measures clearly state that the State Food and Drug Administration can implement special approvals for the following applications:

(1) Active ingredients and preparations extracted from plants, animals, minerals, etc., and newly discovered medicinal materials and preparations that have not been marketed in China;

(2) Chemical raw materials and their preparations and biological products that have not been approved for listing at home and abroad;

(3) New drugs that treat AIDS, malignant tumors, rare diseases and other diseases and have obvious clinical treatment advantages;

(4) New drugs for the treatment of diseases for which there is no effective treatment.

For drugs that meet the provisions of the preceding paragraph, the applicant may submit an application for special approval during the drug registration process, and the SFDA Drug Evaluation Center will organize an expert meeting to discuss and determine whether to implement special approval.

The State Food and Drug Administration’s notice on special approval procedures clearly stated that special approval exchanges can be conducted at different stages.

The meeting is mainly implemented by the SFDA Drug Evaluation Center. At present, the Center for Drug Evaluation has also announced a notice on the implementation of the "Regulations on the Management of Special Approval for New Drug Registration," which clarifies the specific operational requirements for the special approval procedure.

The formulation and implementation of special approval procedures and policies reflects the state's policy support and technical support for new drug research and development.

The Drug Evaluation Center is responsible for the application and implementation of special approval procedures for new drugs. New drug developers can actively apply for a communication meeting in accordance with the Drug Registration Management Measures, and submit the issues to be discussed and related materials at the same time.

The application should clarify the issues to be communicated, and submit the medical review and pharmacy review materials of the new drug, as well as detailed research materials and background information related to the issues to be communicated and communicated.

The Drug Evaluation Center is responsible for reviewing applications for special approval procedures. For registration applications that can be approved for special approval, the Drug Evaluation Center will arrange for applicants to communicate with relevant reviewers within a specified time.

Qiu Shangsong said a lot. After summing up, Tianwang Huxin Pill has three advantages.

The first advantage: Tianwang Huxin Pill is an original research drug, not a generic drug.

The second advantage: Tianwang Huxin Pill is a medicine used to treat serious or life-threatening diseases, and it has the potential to meet clinical unmet medical needs.

The third advantage: The treatment effect is significantly improved compared to the marketed drugs.

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