quot;Drug Registration" to register or self-contained medicine - drugs, registration of Chinese medicine - pharmaceutical industry

quot;Drug Registration" to register or self-contained medicine - drugs

, registration of Chinese medicine - pharmaceutical industry

"We wish for this provision, I hope to meet the new requirements development trend of Chinese medicine to help business development." Zhejiang Kangen Bei Zhu Kuang Shan Group consultancy has an interview with reporters, said he was excited for it before the new regulatory the leaders said on "Chinese Medicine review of the supplementary provisions" to develop.

7 10, much concern to the industry, "Drug Registration" (hereinafter referred to as "measures") was formally promulgated. July 11, SFDA Wu Zhen, deputy director of SFDA for the first time in a regular press conference on the "measures" were interpretation. Problems for traditional Chinese medicine, Wu Zhen said, "means" limitations of space, not for the characteristics of traditional Chinese medicine detailed requirements. Therefore, SFDA to consider "measures" following the enactment of "follow the Chinese laws, reflects Chinese characteristics, promote the development of Chinese medicine, Chinese medicine to improve the quality of" principle, proceed to the drafting of "complementary medicine review of the provisions."

It is reported that work has begun, SFDA is now a joint investigation with the departments concerned, repeated study and solicit opinions. "Chinese Medicine review of the Supplementary Provisions," the first draft will probably not need too long to the public, and comments will be sought with the "Procedures" in the October 1 implementation from the same time.

Revealed the news of a significant response in the industry has basically followed the Western system for declaration of traditional Chinese medicine industry, the ability to have their own rating and review system, an enterprise focus.

Waiting In fact, this is no longer a new topic. And chemical medicine, biological medicine than the traditional Chinese medicine has its own characteristics and rules. Management approach to the registration of Chinese medicine reflect the characteristics and laws of this guide the healthy and rapid development of Chinese medicine, this is there has been concern.

Zhu Kuang Shan said: "The Chinese have long followed the basic evaluation and examination and approval system of Western medicine, the lack of their own standards." It is reported that the standard set of proprietary income is 9328, but experts said: "The vast majority of 10 the standard 20 years ago, involving more than 4,000 kinds of proprietary Chinese medicines and improve quality standards to be improved. "lack of standards has long been a direct result of the poor Chinese quality control, clinical instability, thus affecting the clinical application of Chinese medicine and international market development. But I wish Marina said good, "the introduction of the difficult things," because Chinese medicine can not be separated, and now Chinese heritage issues need to be addressed urgently.

Regardless of "complementary medicine review of the provisions of" how to finalize the specific details of how it will reflect the Chinese characteristics, but the move itself has been brought to the industry's imagination, that is, traditional Chinese medicine processing and chemical differences between drug approval is expected, Traditional Chinese medicine will no longer be in full accordance with the approval of chemical approaches to reporting.

"The introduction of new regulations should be established on the basis of respect for traditional law, so that the development of Chinese medicine has a separate room, and we are waiting." Boss of a large group of Chinese medicine is quite concerned about the message, he that "the original standard is closer to the Western system, and from the practice of proprietary Chinese medicines have a number of issues, including efficacy, clinical, functional descriptions are all indications of contradictions, traditional Chinese medicine system should be preserved." In particular, he hoped that the new regulations In clinical trials, efficacy experiments can be changed, "it is difficult to refer to Western medicine in animal models are lacking." Furthermore, a description of the efficacy of Chinese medicine, should move closer to modern medicine, especially in OTC products, or patients poorly understood.

In a well-known Chinese enterprises are responsible for the registration of the car, Miss, said, "I hope the new rules will truly reflect the characteristics of traditional Chinese medicine, and guide the healthy development of our business."

Moderately tight?

"Mentality now is more contradictory." Medicine at a large group of veterans who told reporters. He explained that one hopes that the new regulations will truly reflect the laws of proprietary Chinese medicines, is also concerned that it will produce proprietary standards are too low, resulting in a low level of repetition, this is business want to see.

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