496 Special approvals

If you haven't found it, you haven't found it, and half a month is not a long time, so I can wait. "Even the second senior brother didn't find out the news of Niu Shengtian, Xiao Yao was a little regretful.

"Little junior brother, when Mrs. Niu is transferred to my medical team, I will tell you her news immediately, but there is only so much I can help you. With Niu Zhiguang's level, I can't refuse the task of treating Mrs. Niu, at most, I can 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 get her to turn around a month later. ”

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

Xiao Yao didn't need the help of the second senior brother, "Niu Shengtian is just a little powerful ordinary man in my eyes, and it's easy for me to deal with him." As long as the second senior brother told me his news in time, the matter could be easily resolved. ”

"Senior brother, the use of the Heavenly King Heart Protector Pill is not bad, right?" Xiao Yao changed the subject.

Qiu Shangsong said excitedly: "The effect is so good! In the past two months, since the clinical use of Tianwang Heart Pills in my group, there have been six patients with severe heart disease who have been completely cured, and 13 people with critical heart disease have been very well controlled. ”

"It's good that there is an effect, your medical team is a general treatment team, and the heart patients are only a small part, I estimate that the clinical effect of other specialized hospitals should be better." During this time, Xiao Yao studied the Heavenly Fortune Divine Technique wholeheartedly, and he didn't know much about the progress of the promotion of the Heavenly King Heart Protection Pill.

"Of course, the medicinal effect of the Heavenly King Heart Protection Pill is so obvious, no matter which hospital it uses it clinically, it is reluctant to give up.

My medical team and the Department of Cardiology of Peking Union Medical College were the first to use Tianwang Xindan, because of the obvious effect, the strongest cardiology departments in the country, such as Fuwai Cardiovascular, Anzhen Hospital, Zhongshan Hospital, Guangdong Provincial People's Hospital, and West China Hospital, which are the top new internal medicine departments in China, have also successively used Tianwang Xindan.

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 Heart Pills in clinical practice.

Nearly 30 large tertiary hospitals help you do clinical work, and all the good reviews received so far have not been found, and no toxic side effects have been found, it seems that the time for Tianwang Huxin Pill to be put on the market will be greatly shortened. Qiu Shangsong was very satisfied with the medicinal effect of the Heavenly King Heart Protection Pill.

"Although the medicinal effect of the Heavenly King Heart Protector Pill is very strong, if you don't have the connections of your senior brother, it is impossible to enter 30 tertiary hospitals for clinical practice, another day, senior brother, you have time, come to the house, and I will prepare something good for you." Xiao Yao has never doubted the prestige of the second senior brother in the medical world.

It is simply a miracle that Tianwang Heart Protector Pill was able to enter 30 large tertiary hospitals for clinical practice in such a short period of time, and it would have been impossible to make such rapid progress without the full promotion of the second senior brother Qiu Shangsong.

Qiu Shangsong did not take credit, "The main thing is that the efficacy of Tianwang Heart Protector Pill is too good, and such a good drug should be marketed as soon as possible to benefit more patients." You can arrange for your professionals to apply for a special approval process, and I can help you with the approval process, which should greatly reduce the time. ”

"Is there a special approval process? I haven't dealt with specific things, so I really don't know about them. ”

"Of course there is ......"

Next, Qiu Shangsong gave Xiao Yao a popular science about the special approval procedure.

As an industry related to the national economy and people's livelihood, the development of medicine and the speed of development directly affect the national health security and quality of life. Among them, the development status of new drug R&D institutions will affect whether China's national pharmaceutical industry can maintain an independent survival state in technology. With the introduction of the national policy to encourage innovation, as well as the technical support of national research centers and research institutes, the domestic new drug R&D and innovation capabilities continue to increase, providing favorable conditions for the domestic new drug R&D.

The Measures for the Administration of Drug Registration officially promulgated by the State Food and Drug Administration clearly put forward the special approval procedures for the review of new drugs.

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

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

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

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

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

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

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

The conference was mainly conducted by the Center for Drug Evaluation (CDE) of the SFDA. At present, the Center for Drug Evaluation (CDE) has also issued a notice on issues related to the implementation of the Administrative Provisions on Special Approval for New Drug Registration, clarifying the specific operational requirements for the special approval procedure.

The formulation and implementation of the special approval procedure policy reflects the national policy support and technical support for the research and development of new drugs.

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

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

The Center for Drug Evaluation (CDE) is responsible for reviewing applications for special approval procedures, and for registration applications that can be approved for special approval, the Center for Drug Evaluation (CDE) will arrange for the applicant to communicate with relevant reviewers within the specified time.

Qiu Shangsong said a lot, and after summarizing, the Heavenly King Heart Protection Pill has three major advantages.

The first major advantage: Tianwang Heart Protector is an original drug, not a generic drug.

The second advantage: Tianwang Xinxin Pill 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 advantage: the therapeutic effect is significantly improved compared with the marketed drugs.