Wu Hao: Three Suggestions to Deal with Market Competition

On September 15, 2012, the annual meeting of Chinese medical entrepreneurs was held in Tianjin. Wu Hao, the deputy director of the State Food and Drug Administration, attended the conference. He emphasized that the rapid development of the pharmaceutical industry and gratifying results also emphasized: “The structural problems caused by the extensive development of China's pharmaceutical industry are increasingly prominent, and drugs that occur from time to time Quality events remind us that the current drug safety situation is not optimistic. We must maintain a high degree of vigilance and we must not be at ease.”

In today's economic globalization and market integration, in the face of the constantly open market and fierce competition, how to improve the market competitiveness of China's pharmaceutical industry has become a real topic in front of the entire industry.

In the face of fierce market competition, Wu Hao made three suggestions:

First, we must focus on improving innovation capabilities. The rapid development of medical science and technology, with each passing day, will only take advantage of the ability to innovate and master critical core technologies to capture the commanding heights in the industry.

In order to enhance the industry's ability to innovate, the drug regulatory department will play a guiding role in administrative approval and make a difference in encouraging innovation. To study the reform and adjustment of the drug registration management system, the overall thinking is: to encourage innovation, and to curb low-level repetition.

Focusing on encouraging innovation, focusing on accelerating the clinical examination and approval of new drugs, especially new drugs; Orienting on clinical needs, optimizing review strategies for generic drugs, accelerating review of first generic drugs, generic drugs, and clinically urgently needed products; using market value assessment, etc. Means to shelve those products with low levels of repetition. Further intensify the verification of clinical research, strengthen the standardization of clinical trial institutions, and further enhance the capabilities and level of clinical research.

Second, we will solidly promote the implementation of GMP. One of the important tasks of drug supervision at present is to promote the implementation of the newly revised pharmaceutical GMP, which is a major event for the entire industry. To implement the newly revised GMP, we must understand its connotation and essence.

We emphasize the establishment of a strict production management system and a sound quality assurance system. Each employee firmly establishes the quality awareness of the entire process; we encourage companies to invest more in quality system construction and employee training, and oppose blind expansion to prevent " The phenomenon of "hardware, light software" has occurred; we will strictly adhere to the standards, strictly observe the time limit, and eliminate the phenomena of looseness and unevenness. We will also study and formulate encouragement policies and support measures with related departments to guide enterprises to expedite the implementation of newly revised pharmaceutical GMPs and facilitate the integration of resources, optimization of structures, and merger and reorganization of enterprises.

Third, actively implement the "going out" strategy. "Going out" is a national strategy. It is an unavoidable choice for the development of China's pharmaceutical industry, and it is also our need to improve ourselves. It is hoped that China's outstanding enterprises will boldly go out, accept international supervision, participate in international competition, open up international markets, and win wider space for development.

At the same time, drug supervision must also go out and participate in international exchanges and cooperation with a more open attitude. Through international exchanges and cooperation, we can learn advanced foreign management experience and methods, improve our country's laws and regulations, and achieve international standards, and promote China's pharmaceutical industry to go abroad.