The new version of GMP is being sent to the pharmaceutical industry to come to life and death
Release time: 2010-08-19 & nbsp & nbsp & nbsp Source:
12 years ago，China promulgated GMP certification，More than 1,300 pharmaceutical companies died outside this "threshold"，Now，The threshold for life and death in the second round will come again。
This newspaper learned，The new version of the new version of GMP hosted by the State Drug Administration is being sent to the Ministry of Health，A person from the drug supervision bureau disclosed，It should end the review within this year，But when will it be introduced "Unclear"。
It is understood，The new version of GMP focuses on the improvement of production enterprise software and facilities，Including a set of perfect、Mature management system，It is used to detect the person who appears in the production process、negligence and other vulnerabilities，Including raw materials、Process process、Disinfection、stake betting appTechnology、stake online sports bettingFormula Preparation、Library、Logistics and other links。
"If there is a problem in a certain link，You can find the key in time through the management system。"Yang Zi, the boss of a pharmaceutical company in Beijing, told this newspaper。
2010 was originally the autumn of events in the pharmaceutical industry，The above -mentioned rigorous regulatory situation，For the situation of most small and medium -sized pharmaceutical companies, it is undoubtedly worse。Urgent of the macroeconomic environment，Suppression of the basic drug system，Medicine anti -corruption heating，plus the step -by -step approximation of the new version of GMP，further accelerated the integration and merger of the pharmaceutical industry。
Regulatory supplementary classes
The promulgation and implementation date of the new version of GMP，Last year, the media said that it was promoted as soon as possible，But until now，This standard is still in the brewing period，Drug Administration said that there is no accurate statement。
According to the insiders of the State Drug Administration，The new version of GMP is sent to Shao Mingli, director of the State Drug Administration，"(He) before signing，Still discussed with the deputy directors several times，Perform some modifications "，At present, the work at the level of the drug supervision bureau has ended，In the process of being sent to the Ministry of Health。
Since the regulations of the ministry involve the Ministry of Health Policy Department、The work of the regulations and regulations，So the leadership of the Ministry of Health should be reviewed，After that, you need to consult the opinions of other ministries and commissions，For example, after hearing、Public announcement and solicitation of comments。
stake sports betting appStake Sports BettingAccording to the health system person，The implementation of the new version of GMP，On the one hand, it takes time to take a program，On the other hand, the relevant departments are also more cautious。
Former Director of the State Drug Administration, Zheng Xiaoyu, promulgated the 1998 version of GMP，The pharmaceutical market has experienced a large shuffle; but at the same time，The implementation of GMP also aggravated the collection of the drug supervision system，Corruption quickly breeds under centralization。"The implementation of the old version of GMP，Let more than 3700 pharmaceutical companies pay more than 150 billion threshold fees，and the drug supervision system eventually ushered in a large -blooded official。"The person said。
The root cause is，The old version of the GMP is implemented，Is a certificate issued by the State Drug Administration，Local Drug Administration on -site assessment review，"This method ultimately leads to vulnerabilities in both levels，National Bureau、Officials from the local bureau frequently disappear。"A drug supervisor said，The new version of GMP is restraining the behavior of corporate behavior，It is also necessary。
Although how to allocate supervision power for the new version of GMP，No more consistent opinions have been formed among the Ministry of Pharmaceutical Supervision Bureau and the Ministry of Health，But you can see，Requirements for regulatory objects and regulatory methods，It has obviously tended to strict。
1998 version of GMP implementation，improved the plant、Purification、production equipment and other hardware indicators，Only more than 3,700 manufacturers have jumped over the threshold。But some companies that leap the threshold still broke out of drug safety incidents in the future，Ru Qi two medicines and My stake betting appstake sports betting appHuayuan，Enterprises to pursue profit，Reduce the cost of raw materials，Replaced with unsafe medicinal ingredients，As a result, the patient's death and other incidents occurred。
It is understood，The launch of the new version of GMP，aimed at supervising and timely discovery、Detecting vulnerabilities in the pharmaceutical process，Effectively curb the occurrence of adverse drugs ??，Treating a new round of market life and death war。
The potential of mergers
"The basic drug system just implemented this year，Most small and medium -sized enterprises' drug prices are greatly suppressed，There are nearly a quarter of small and medium -sized enterprises are facing survival dilemma。"Yu Mingde, vice chairman of the China Medical Enterprise Management Association，When facing the new version of the GMP test again，Although it is given a 3 -year buffer period for small and medium -sized enterprises，But thousands of small and medium -sized enterprises will eventually die on the GMP threshold。
Current，4700 domestic pharmaceutical companies，Small and medium -sized companies account for about 70%，That is more than 3,200 people。
Where，The best annual sales are about 100 million，and nearly 70%of small and medium -sized enterprises with an annual sales of about 50 million，Net profit is about 10 million to 20 million。If you reach the standard，Some companies have invested at least tens of millions，High hundreds of millions of high。
It seems，The implementation of the new version of GMP，While improving the quality of the drug，It is also a way to promote the integration of pharmaceutical companies。
Wang Longxing, Secretary of the Party Committee of Shanghai Health Bureau，Many small business bosses do not know the operation process of the enterprise only knows the profit stake online sports bettingStake Sports Bettingof the enterprise，I don’t know the situation of the workshop，All hired people are operating，As a result, there are repeated medical adverse events。"Good products are not supervised，But not management is the easiest problem。Europe is merging and merging、Integration and re -integration results，Unable to live first。”
This newspaper learned，The new version of the new version of GMP hosted by the State Drug Administration is being sent to the Ministry of Health，A person from the drug supervision bureau disclosed，It should end the review within this year，But when will it be introduced "Unclear"。
It is understood，The new version of GMP focuses on the improvement of production enterprise software and facilities，Including a set of perfect、Mature management system，It is used to detect the person who appears in the production process、negligence and other vulnerabilities，Including raw materials、Process process、Disinfection、stake betting appTechnology、stake online sports bettingFormula Preparation、Library、Logistics and other links。
"If there is a problem in a certain link，You can find the key in time through the management system。"Yang Zi, the boss of a pharmaceutical company in Beijing, told this newspaper。
2010 was originally the autumn of events in the pharmaceutical industry，The above -mentioned rigorous regulatory situation，For the situation of most small and medium -sized pharmaceutical companies, it is undoubtedly worse。Urgent of the macroeconomic environment，Suppression of the basic drug system，Medicine anti -corruption heating，plus the step -by -step approximation of the new version of GMP，further accelerated the integration and merger of the pharmaceutical industry。
Regulatory supplementary classes
The promulgation and implementation date of the new version of GMP，Last year, the media said that it was promoted as soon as possible，But until now，This standard is still in the brewing period，Drug Administration said that there is no accurate statement。
According to the insiders of the State Drug Administration，The new version of GMP is sent to Shao Mingli, director of the State Drug Administration，"(He) before signing，Still discussed with the deputy directors several times，Perform some modifications "，At present, the work at the level of the drug supervision bureau has ended，In the process of being sent to the Ministry of Health。
Since the regulations of the ministry involve the Ministry of Health Policy Department、The work of the regulations and regulations，So the leadership of the Ministry of Health should be reviewed，After that, you need to consult the opinions of other ministries and commissions，For example, after hearing、Public announcement and solicitation of comments。
stake sports betting appStake Sports BettingAccording to the health system person，The implementation of the new version of GMP，On the one hand, it takes time to take a program，On the other hand, the relevant departments are also more cautious。
Former Director of the State Drug Administration, Zheng Xiaoyu, promulgated the 1998 version of GMP，The pharmaceutical market has experienced a large shuffle; but at the same time，The implementation of GMP also aggravated the collection of the drug supervision system，Corruption quickly breeds under centralization。"The implementation of the old version of GMP，Let more than 3700 pharmaceutical companies pay more than 150 billion threshold fees，and the drug supervision system eventually ushered in a large -blooded official。"The person said。
The root cause is，The old version of the GMP is implemented，Is a certificate issued by the State Drug Administration，Local Drug Administration on -site assessment review，"This method ultimately leads to vulnerabilities in both levels，National Bureau、Officials from the local bureau frequently disappear。"A drug supervisor said，The new version of GMP is restraining the behavior of corporate behavior，It is also necessary。
Although how to allocate supervision power for the new version of GMP，No more consistent opinions have been formed among the Ministry of Pharmaceutical Supervision Bureau and the Ministry of Health，But you can see，Requirements for regulatory objects and regulatory methods，It has obviously tended to strict。
1998 version of GMP implementation，improved the plant、Purification、production equipment and other hardware indicators，Only more than 3,700 manufacturers have jumped over the threshold。But some companies that leap the threshold still broke out of drug safety incidents in the future，Ru Qi two medicines and My stake betting appstake sports betting appHuayuan，Enterprises to pursue profit，Reduce the cost of raw materials，Replaced with unsafe medicinal ingredients，As a result, the patient's death and other incidents occurred。
It is understood，The launch of the new version of GMP，aimed at supervising and timely discovery、Detecting vulnerabilities in the pharmaceutical process，Effectively curb the occurrence of adverse drugs ??，Treating a new round of market life and death war。
The potential of mergers
"The basic drug system just implemented this year，Most small and medium -sized enterprises' drug prices are greatly suppressed，There are nearly a quarter of small and medium -sized enterprises are facing survival dilemma。"Yu Mingde, vice chairman of the China Medical Enterprise Management Association，When facing the new version of the GMP test again，Although it is given a 3 -year buffer period for small and medium -sized enterprises，But thousands of small and medium -sized enterprises will eventually die on the GMP threshold。
Current，4700 domestic pharmaceutical companies，Small and medium -sized companies account for about 70%，That is more than 3,200 people。
Where，The best annual sales are about 100 million，and nearly 70%of small and medium -sized enterprises with an annual sales of about 50 million，Net profit is about 10 million to 20 million。If you reach the standard，Some companies have invested at least tens of millions，High hundreds of millions of high。
It seems，The implementation of the new version of GMP，While improving the quality of the drug，It is also a way to promote the integration of pharmaceutical companies。
Wang Longxing, Secretary of the Party Committee of Shanghai Health Bureau，Many small business bosses do not know the operation process of the enterprise only knows the profit stake online sports bettingStake Sports Bettingof the enterprise，I don’t know the situation of the workshop，All hired people are operating，As a result, there are repeated medical adverse events。"Good products are not supervised，But not management is the easiest problem。Europe is merging and merging、Integration and re -integration results，Unable to live first。”
