Innovation is Encouraged in Drug Registration, “New, Excellent and Same” is Required in Application
news 9/21/2010
Encourage innovation is the core of drug registration, the State Food and Drug Administration (SFDA) encourages innovation in the process of drug registration, and requires the drugs for registration are of “New, Excellent, Same” to improve the research and development of drugs.
Mr. Wu Zhen, the deputy director of SFDA raised the requests above during Drug Registration Management Conference held in Wuhan on 4th Feb. “New” stands for creative drugs with excellent efficacy, it is not only the new compounds, new formulations, new technology, new dosage form, but also the new efficacy.
The obvious advantages in clinical usage should be indicated for drugs with updated dosage form. The dosage form change must be reasonable and scientific. If there are no any advantages for updated dosage in clinical usage, it will not be approved. There was no one approved for updated dosage form in 59 traditional Chinese medicines approved in 2009.
Generic drugs should be equivalent with innovative drugs. It is required that the quality, manufacturing process and therapeutic effect of generics should be consistent with those of innovative drugs. At present, generics are still the main part of drug registration in China. However, compared with that of developed countries, generics manufactured in China also have certain disparity. So, generic drug manufacturers must provide the comparison data with the innovative drugs.
Mr. Wu Zhen said the same requirements of “New, Excellent and Same” are based on innovation, he required drug manufacturer to innovate or re-innovate. No mater innovative drugs, or generics, updated dosage forms, the effectiveness is one of the important basics for marketing approval.
Mr. Wu Zhen, the deputy director of SFDA raised the requests above during Drug Registration Management Conference held in Wuhan on 4th Feb. “New” stands for creative drugs with excellent efficacy, it is not only the new compounds, new formulations, new technology, new dosage form, but also the new efficacy.
The obvious advantages in clinical usage should be indicated for drugs with updated dosage form. The dosage form change must be reasonable and scientific. If there are no any advantages for updated dosage in clinical usage, it will not be approved. There was no one approved for updated dosage form in 59 traditional Chinese medicines approved in 2009.
Generic drugs should be equivalent with innovative drugs. It is required that the quality, manufacturing process and therapeutic effect of generics should be consistent with those of innovative drugs. At present, generics are still the main part of drug registration in China. However, compared with that of developed countries, generics manufactured in China also have certain disparity. So, generic drug manufacturers must provide the comparison data with the innovative drugs.
Mr. Wu Zhen said the same requirements of “New, Excellent and Same” are based on innovation, he required drug manufacturer to innovate or re-innovate. No mater innovative drugs, or generics, updated dosage forms, the effectiveness is one of the important basics for marketing approval.
