New version of GMP revised draft or increase threshold at least 500 small and medium -sized pharmaceutical companies to shut down
Release time: 2010-01-15 & nbsp & nbsp & nbsp Source:
My stake betting app"The drug GMP originally planned at the end of 2009 will be announced in the first quarter of this year，It is expected that the implementation of new specifications will shut down at least 500 small and medium -sized enterprises in the country，Compliant enterprises will cost 20 billion to 300 billion yuan for hardware investment。"GMP is" Specification of Drug Production Quality Management "。
The above news is the relevant person in charge of the State Food and Drug Administration (SFDA) Drug Safety Supervision Department of Pharmaceutical Safety Supervision at Peking University's "2010 Drug Quality and Global Competitive International Symposium"。
"I opened dozens of times，Finally, the GMP revision manuscript was reported to the Law Division on the last day My stake betting appstake online sports bettingof 2009，completed the technical level work。"The person in charge disclosed。
Pay more attention to dynamic supervision after product listing
Different from the 1998 version of GMP emphasized equipment、Factory and other hardware specifications，The State Drug Administration has repeatedly emphasized，The 2010 2010 version will pay more attention to the continuity of the company's products、Dynamic supervision，Emphasize management、Personnel and other "software" control。
The person in charge pointed out at the same time，Since the requirements for quality management are strengthened，From the average number of quality control technologies with the current enterprise，The level of 15%from the international average is far away，Overall estimation，Production enterprise quality control personnel need to double，At about 100,000 people，The labor cost that this part has to spend will also be a "big number"。
Li Lei, Director of the Expert Office of the Integrated Research Group of Chinese Pharmaceutical Enterprises, conducted multiple research on the previous round of GMP certification，His estimate，The total capital of the previous round of GMP national pharmaceutical companies was about 150 billion yuan，Among them, 30%of them come from bank loans。
Previous，The revised version of GMP by the 1998 revised version of 1998，China has eliminated the total number of national pharmaceutical preparations and chemical raw materials from more than 6,000 to 4700。
Dested，Because it is widely involved、The impact is huge，Since its launch，GMP even directly affects the life and death Stake Sports BettingStake Sports Bettingof the enterprise ?? Since the establishment of the State Drug Administration in 1998，GMP becomes a threshold for pharmaceutical companies to cross ?? Companies that have not obtained GMP certification cannot obtain production licenses，There is no "birth certificate"。
and another reality of that year is，Due to the blind horses and the standards are not strict，2004 GMP compulsory certification also caused a lot of idleness in the production capacity of the pharmaceutical industry。
In view of this，The State Drug Administration said，This time GMP is integrated at the target industry，It will also carefully consider the implementation of centralized certification ?? "Preliminary idea is，New buildings and workshops need to be implemented in accordance with the new GMP，The transformation of the old plant and other buildings will have a transition period of about 2 years。"The head of the Security Supervision Bureau of the State Drug Administration said on the previous industry forum。
Prepare to enter the international market
Dested，For the increasingly accelerated dualization of the Chinese pharmaceutical industry，Although the new version of GMP is wrapped in pressure, it is about to scream，But for the enterprises and pharmaceutical industries in the pole，Matthew effect is still obvious。
Because most of the products are exported，When GMP forced certification in 2004，A listed company in Jiangsu has "improved the standard" in advance，The executive of the company told the First Financial Daily: "GMP should be‘ high or low ’，Domestic and EU、FDA in the United States is a matter of morning and evening，At that time, My stake betting appour condition allowed，stake online sports bettingTherefore, the hardware transformation of many production lines is implemented in accordance with US standards。”
Although it has grown into a pharmaceutical company in the first echelon in China，But the person in charge said，According to the new version of GMP content announced by the last online solicitation comments，This company still has some production lines and workshops that require hardware transformation，"Rough estimation，It also costs 10 million to 20 million yuan input "。
And he thinks，Such investment，For a large number of small and medium -sized enterprises that can only be simply maintained，I'm afraid it is difficult to afford it? "If the relevant departments can strictly implement this time，There are definitely more than 500 companies that fall down。”
Zhejiang Haizheng Pharmaceutical (600267.SH) also follows an export -oriented development road，At present, 37 kinds of raw medicines have passed FDA and EU certification，6 preparations obtained international certification。
Zhu Kangqin, Assistant General Manager of Haizheng Pharmaceutical, told reporters: "For companies with better domestic development，Many production lines have been promoted to Europe and the United States standards in recent years，Because I want to export the international market，The standard is inconsistent，If others do not agree，We can't get out at all
Go. "
and this point，It is also the intention of the State Drug Administration to adhere to the GMP standard，"Let my country's drug production get international recognition，Let more Chinese pharmaceutical enter the international market。"The person in charge of My stake betting appthe Safety Supervision My stake betting appDepartment of the State Drug Administration pointed out。
Shijiazhuang Pharmaceutical Group will have 3 production workshops in March this year to welcome FDA on -site inspection，Chairman Cai Dongchen confessed: "In the past, we felt that the equipment was advanced、Good on the production line、Exaggerated ones，but now I found out with the officials of the FDA before discovering，For GMP，The more core spirit is the concept of dynamic supervision and full supervision。"and he thinks，From this point，"The road to promoting GMP in China is still long，It will also be very difficult "。
The above news is the relevant person in charge of the State Food and Drug Administration (SFDA) Drug Safety Supervision Department of Pharmaceutical Safety Supervision at Peking University's "2010 Drug Quality and Global Competitive International Symposium"。
"I opened dozens of times，Finally, the GMP revision manuscript was reported to the Law Division on the last day My stake betting appstake online sports bettingof 2009，completed the technical level work。"The person in charge disclosed。
Pay more attention to dynamic supervision after product listing
Different from the 1998 version of GMP emphasized equipment、Factory and other hardware specifications，The State Drug Administration has repeatedly emphasized，The 2010 2010 version will pay more attention to the continuity of the company's products、Dynamic supervision，Emphasize management、Personnel and other "software" control。
The person in charge pointed out at the same time，Since the requirements for quality management are strengthened，From the average number of quality control technologies with the current enterprise，The level of 15%from the international average is far away，Overall estimation，Production enterprise quality control personnel need to double，At about 100,000 people，The labor cost that this part has to spend will also be a "big number"。
Li Lei, Director of the Expert Office of the Integrated Research Group of Chinese Pharmaceutical Enterprises, conducted multiple research on the previous round of GMP certification，His estimate，The total capital of the previous round of GMP national pharmaceutical companies was about 150 billion yuan，Among them, 30%of them come from bank loans。
Previous，The revised version of GMP by the 1998 revised version of 1998，China has eliminated the total number of national pharmaceutical preparations and chemical raw materials from more than 6,000 to 4700。
Dested，Because it is widely involved、The impact is huge，Since its launch，GMP even directly affects the life and death Stake Sports BettingStake Sports Bettingof the enterprise ?? Since the establishment of the State Drug Administration in 1998，GMP becomes a threshold for pharmaceutical companies to cross ?? Companies that have not obtained GMP certification cannot obtain production licenses，There is no "birth certificate"。
and another reality of that year is，Due to the blind horses and the standards are not strict，2004 GMP compulsory certification also caused a lot of idleness in the production capacity of the pharmaceutical industry。
In view of this，The State Drug Administration said，This time GMP is integrated at the target industry，It will also carefully consider the implementation of centralized certification ?? "Preliminary idea is，New buildings and workshops need to be implemented in accordance with the new GMP，The transformation of the old plant and other buildings will have a transition period of about 2 years。"The head of the Security Supervision Bureau of the State Drug Administration said on the previous industry forum。
Prepare to enter the international market
Dested，For the increasingly accelerated dualization of the Chinese pharmaceutical industry，Although the new version of GMP is wrapped in pressure, it is about to scream，But for the enterprises and pharmaceutical industries in the pole，Matthew effect is still obvious。
Because most of the products are exported，When GMP forced certification in 2004，A listed company in Jiangsu has "improved the standard" in advance，The executive of the company told the First Financial Daily: "GMP should be‘ high or low ’，Domestic and EU、FDA in the United States is a matter of morning and evening，At that time, My stake betting appour condition allowed，stake online sports bettingTherefore, the hardware transformation of many production lines is implemented in accordance with US standards。”
Although it has grown into a pharmaceutical company in the first echelon in China，But the person in charge said，According to the new version of GMP content announced by the last online solicitation comments，This company still has some production lines and workshops that require hardware transformation，"Rough estimation，It also costs 10 million to 20 million yuan input "。
And he thinks，Such investment，For a large number of small and medium -sized enterprises that can only be simply maintained，I'm afraid it is difficult to afford it? "If the relevant departments can strictly implement this time，There are definitely more than 500 companies that fall down。”
Zhejiang Haizheng Pharmaceutical (600267.SH) also follows an export -oriented development road，At present, 37 kinds of raw medicines have passed FDA and EU certification，6 preparations obtained international certification。
Zhu Kangqin, Assistant General Manager of Haizheng Pharmaceutical, told reporters: "For companies with better domestic development，Many production lines have been promoted to Europe and the United States standards in recent years，Because I want to export the international market，The standard is inconsistent，If others do not agree，We can't get out at all
Go. "
and this point，It is also the intention of the State Drug Administration to adhere to the GMP standard，"Let my country's drug production get international recognition，Let more Chinese pharmaceutical enter the international market。"The person in charge of My stake betting appthe Safety Supervision My stake betting appDepartment of the State Drug Administration pointed out。
Shijiazhuang Pharmaceutical Group will have 3 production workshops in March this year to welcome FDA on -site inspection，Chairman Cai Dongchen confessed: "In the past, we felt that the equipment was advanced、Good on the production line、Exaggerated ones，but now I found out with the officials of the FDA before discovering，For GMP，The more core spirit is the concept of dynamic supervision and full supervision。"and he thinks，From this point，"The road to promoting GMP in China is still long，It will also be very difficult "。
