Inherit For Three Thousand Years

"If you didn't find out, then you didn't find out. Half a month is not long, I can wait." Even the second senior brother didn't find out about Niu Shengtian, Xiao Yao felt a little regretful.

"Junior brother, after Mrs. Niu transfers to my medical team, I will tell you the news about her immediately, but there is only so much I can help you with. With Niu Zhiguang's level, the task of healing Mrs. Niu is beyond me. It is impossible to refuse, at most it is to find a reason to let her transfer to my medical team later. But I have already agreed to this matter, and now I can't go back. Otherwise, I can let her delay by one at most Turn around."

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

Xiao Yao doesn't need the help of the second senior brother, "Niu Shengtian is just an ordinary man with some power in my eyes. It's easy for me to deal with him. As long as the second senior brother tells me the news about him in time, things will be resolved easily." It can be solved."

"Senior brother, the Tianwang Huxin Pill works well, right?" Xiao Yao changed the subject.

Qiu Shangsong said excitedly: "The effect is great! In the past two months, since Tianwang Huxin Pill was clinically used in my group, six patients with severe heart disease have been completely cured, and 13 patients with critical heart disease have been cured. The disease has been very well controlled, and although it will be difficult to cure in the future, as long as he takes Tianwang Buxin Dan for a long time, at least he will not die of heart disease."

"It's good if it works. Your medical team is a general treatment team, and heart disease patients are only a small part. I guess the clinical effect of other specialized hospitals should be better." During this time, Xiao Yao devoted himself to studying the God of Fortune. I don't know much about the promotion progress 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, it is reluctant to give up.

My medical team and Union 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, Huaxi Hospital and other top-ranked new internal medicine departments in China are all over the country. The most powerful cardiology departments have 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 started to use Tianwang Huxin Dan clinically.

Nearly 30 large tertiary hospitals have done clinical work for you, and all received positive comments so far, and no toxic side effects have been found. It seems that the time for Tianwang Huxin Dan to be introduced to the market will inevitably be greatly shortened. "Qiu Shangsong is very satisfied with the efficacy of Tianwang Huxin Pill.

"Although the medicinal effect of Tianwang Huxin Pill is very strong, if you don't have the connections of senior brother, it is impossible to enter 30 tertiary hospitals for clinical practice. Brother, if you have time, come to the house some other day, and I will prepare something for you. "Xiao Yao never doubted the prestige of the second senior brother in the medical field.

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

Qiu Shangsong didn't take credit for it, "The main reason is that Tianwang Huxin Pill is so effective. Such a good drug should be on the market earlier to benefit more patients. You can arrange for your professionals to apply for a special approval process. It will also help you push the envelope, and the approval process should reduce the time considerably.”

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

"Of course there is..."

Next, Qiu Shangsong gave Xiao Yao some information about the special approval procedures.

As an industry related to the national economy and people's livelihood, medicine has a direct impact on national health protection 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 and independent existence in technology. With the promulgation of national policies to encourage innovation, and with the technical support of national research centers and research institutes, domestic new drug R\u0026D and innovation capabilities continue to increase, providing favorable conditions for domestic new drug R\u0026D.

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

In the new measures, it is clearly pointed out that the State Food and Drug Administration may implement special approval for the following applications:

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

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

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

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

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

In the relevant notice of the special approval procedure issued by the State Food and Drug Administration, it is clearly pointed out that communication meetings for special approval can be held at different stages.

The meeting is mainly implemented by SFDA Center for Drug Evaluation. At present, the Center for Drug Evaluation has also issued a notice on issues related to the implementation of the "Regulations on the Administration of Special Approval for New Drug Registration", clarifying the specific operational requirements for the special approval process.

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

The Center for Drug Evaluation is responsible for the application and implementation of special approval procedures for new drugs. New drug developers can actively apply for communication meetings in accordance with the drug registration management measures, and submit the issues to be discussed and relevant materials at the same time.

When applying, the issues to be communicated should be clarified, and the medical review and pharmaceutical review materials of the new drug, as well as detailed research materials and background information related to the issues to be communicated should be submitted together.

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

Qiu Shangsong said a lot, after summarizing, Tianwang Huxin Pill has three major advantages.

The first big advantage: Tianwang Huxin Dan is an original drug, not a generic drug. .

The second biggest advantage: Tianwang Huxin Dan is a drug used to treat serious or life-threatening diseases, and has the potential to meet unmet medical needs in clinical practice.

The third major advantage: It has a significant improvement in the effect of treatment compared with the drugs already on the market.