The new version of the GMP will set up a 3 -year transition -time pharmaceutical company that will not meet the standards within the time limit
Release time: 2010-06-03 & nbsp & nbsp & nbsp Source:
Reporter yesterday (June 2) learned,The revision of the new version of the drug production quality management specification (GMP) revised related technical levels of the new version of the drug production have all ended,will be promulgated to the outside world。
"After the new version of GMP is implemented,It will be given a three -year transition period for enterprises,Enterprises or workshops that do not meet the standards will be ordered to stop production。"on the forum of the 10th World Pharmaceutical Materials China Exhibition in Shanghai on June 2,The relevant person in charge of the Safety Supervision Department of the State Food and Drug Administration revealed。It is estimated to,The new version of GMP may be promulgated in July this year。
My stake betting appIt is understood,my country is currently implemented in the 1998 version of the GMP specification。More than 10 years apart this time,After September last year、Public public solicitation of opinions and more than 10 drafts in December,The upcoming new version of GMP puts forward higher requirements for the production quality management specifications of drug production enterprises,Because it involves some manufacturing input,It also affects the nerves of drug production enterprises。
Director Guo Qingwu, Director of the Department of Drug Safety Supervision of the State Drug Administration, revealed at the above forum on June 2,Current,The new version of GMP has been approved by the Affairs Bureau of the Pharmaceutical Supervision Bureau on May 20th,All the technical level work has been completed,It will be reported to the Ministry of Health in accordance with the procedure of the Regulations Department of the Drug Administration,Finally promulgated by the Ministry of Health。
"Technical level from the entire country、For production situation,It may bring some negative effects,Therefore, the relevant national parties are also more cautious about the content and implementation methods of the country。Previously planned to be promulgated at the end of June,But now it seems,It may be difficult。"But,A person from a pharmaceutical supervision bureau estimate in an interview with the Daily Economic News,"If not promulgated in June,It should be in July。”
According to an introduction,The basic principle of implementing the new version of GMP is,New enterprises or workshops should meet the new version of GMP requirements,Certified stake online sports bettingaccording Stake Sports Bettingto the new specification,The existing enterprise that has been certified by the original GMP is given a 3 -year transition period。If the new version of GMP requirements cannot be met after the transition period,Will be ordered to discontinue production,and the drug supervision department will also publicize the results of supervision and inspection online。
"This is compulsory。During the transition period, you can follow the new standard,can also be implemented according to the old standard,But at the latest no more than 3 years。"The above person said。
According to disclosure,Relevant departments also require the production of basic drugs、Enterprises of the syringe variety reached requirements within two years after the implementation of the new version of GMP,Proper extension of hardware transformation,What needs to be extended,Report the implementation process to the local regulatory authorities within two years after implementation,But at the latest does not exceed 3 years。
"Enterprises or workshops that have not reached the required of the new version of GMP at the specified time limit,Should actively suspend production,If it is produced,but the new version of GMP requirements are not met,Even if the product inspection is qualified,It is not allowed to enter the market。"The above person said。
Encourage enterprises to improve certification standards
Previous,Relevant ministries and commissions expect "Implementation of the New GMP specification,Compliance companies only cost 20 billion to 300 billion yuan for hardware investment。"Yesterday,The relevant person in charge of the above pharmaceutical supervision bureau clarified this,Based on the latest investment assessment calculation,Investment should be between 30 billion and 50 billion yuan,and this calculation is based on the factory building of 1/3 of the company,All removal and rebuild,and calculate according to the standards of domestic high -end equipment,It can be said that it is "full of full calculation"。
According to statistics,At present, there are more than 6,000 pharmaceutical manufacturers in my country,Some people with the drug supervision department previously called,It is expected that the implementation of this new specification will shut down at least 500 small and medium -sized enterprises in the country。From an enterprise,,In the short term, it will undoubtedly face the pressure of GMP transformation。The above -mentioned person pointed out,The intention to improve the GMP standard is to improve the level of production technology,Let my country's drug production get internationally recognized,Better into the international market。From the long run,It is conducive to the standardized development of the industry。
but,Extreme pharmaceutical companies will not worry too much about the implementation of the new version of GMP。Yesterday,Relevant person in charge of Haizheng Pharmaceutical, which is mainly exported, told reporters,"Actually the new version of the new version of GMP has a small impact on us,At present, some old workshops and factories are in accordance with the old GMP standard,Due to the current enterprise product export accounts for 80%,All new workshops are built in accordance with US standards。”
In addition,Chairman of the Chinese Medical Enterprise Management Association Yu Mingde revealed to My stake betting appstake online sports bettingreporters,Current Ministry of Science and Technology、Relevant departments of the Development and Reform Commission are making a special,Using government financial resources to support pharmaceutical manufacturers through the requirements of higher international GMP,Including the European Union、American FDA certification, etc.,Support the company "going global"。
"After the new version of GMP is implemented,It will be given a three -year transition period for enterprises,Enterprises or workshops that do not meet the standards will be ordered to stop production。"on the forum of the 10th World Pharmaceutical Materials China Exhibition in Shanghai on June 2,The relevant person in charge of the Safety Supervision Department of the State Food and Drug Administration revealed。It is estimated to,The new version of GMP may be promulgated in July this year。
My stake betting appIt is understood,my country is currently implemented in the 1998 version of the GMP specification。More than 10 years apart this time,After September last year、Public public solicitation of opinions and more than 10 drafts in December,The upcoming new version of GMP puts forward higher requirements for the production quality management specifications of drug production enterprises,Because it involves some manufacturing input,It also affects the nerves of drug production enterprises。
Director Guo Qingwu, Director of the Department of Drug Safety Supervision of the State Drug Administration, revealed at the above forum on June 2,Current,The new version of GMP has been approved by the Affairs Bureau of the Pharmaceutical Supervision Bureau on May 20th,All the technical level work has been completed,It will be reported to the Ministry of Health in accordance with the procedure of the Regulations Department of the Drug Administration,Finally promulgated by the Ministry of Health。
"Technical level from the entire country、For production situation,It may bring some negative effects,Therefore, the relevant national parties are also more cautious about the content and implementation methods of the country。Previously planned to be promulgated at the end of June,But now it seems,It may be difficult。"But,A person from a pharmaceutical supervision bureau estimate in an interview with the Daily Economic News,"If not promulgated in June,It should be in July。”
According to an introduction,The basic principle of implementing the new version of GMP is,New enterprises or workshops should meet the new version of GMP requirements,Certified stake online sports bettingaccording Stake Sports Bettingto the new specification,The existing enterprise that has been certified by the original GMP is given a 3 -year transition period。If the new version of GMP requirements cannot be met after the transition period,Will be ordered to discontinue production,and the drug supervision department will also publicize the results of supervision and inspection online。
"This is compulsory。During the transition period, you can follow the new standard,can also be implemented according to the old standard,But at the latest no more than 3 years。"The above person said。
According to disclosure,Relevant departments also require the production of basic drugs、Enterprises of the syringe variety reached requirements within two years after the implementation of the new version of GMP,Proper extension of hardware transformation,What needs to be extended,Report the implementation process to the local regulatory authorities within two years after implementation,But at the latest does not exceed 3 years。
"Enterprises or workshops that have not reached the required of the new version of GMP at the specified time limit,Should actively suspend production,If it is produced,but the new version of GMP requirements are not met,Even if the product inspection is qualified,It is not allowed to enter the market。"The above person said。
Encourage enterprises to improve certification standards
Previous,Relevant ministries and commissions expect "Implementation of the New GMP specification,Compliance companies only cost 20 billion to 300 billion yuan for hardware investment。"Yesterday,The relevant person in charge of the above pharmaceutical supervision bureau clarified this,Based on the latest investment assessment calculation,Investment should be between 30 billion and 50 billion yuan,and this calculation is based on the factory building of 1/3 of the company,All removal and rebuild,and calculate according to the standards of domestic high -end equipment,It can be said that it is "full of full calculation"。
According to statistics,At present, there are more than 6,000 pharmaceutical manufacturers in my country,Some people with the drug supervision department previously called,It is expected that the implementation of this new specification will shut down at least 500 small and medium -sized enterprises in the country。From an enterprise,,In the short term, it will undoubtedly face the pressure of GMP transformation。The above -mentioned person pointed out,The intention to improve the GMP standard is to improve the level of production technology,Let my country's drug production get internationally recognized,Better into the international market。From the long run,It is conducive to the standardized development of the industry。
but,Extreme pharmaceutical companies will not worry too much about the implementation of the new version of GMP。Yesterday,Relevant person in charge of Haizheng Pharmaceutical, which is mainly exported, told reporters,"Actually the new version of the new version of GMP has a small impact on us,At present, some old workshops and factories are in accordance with the old GMP standard,Due to the current enterprise product export accounts for 80%,All new workshops are built in accordance with US standards。”
In addition,Chairman of the Chinese Medical Enterprise Management Association Yu Mingde revealed to My stake betting appstake online sports bettingreporters,Current Ministry of Science and Technology、Relevant departments of the Development and Reform Commission are making a special,Using government financial resources to support pharmaceutical manufacturers through the requirements of higher international GMP,Including the European Union、American FDA certification, etc.,Support the company "going global"。
