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On February 17, Shanghai Sunshine Pharmaceutical Purchasing Network issued the "Notice on Carrying out the Information Reporting of the Seventh Batch of State-Organized Centralized Drug Procurement".
From February 18, 2022, the Joint Procurement Office will carry out the seventh batch of state-organized drugs.
Centralize the filling and reporting of drug information related to procurement
.
From February 18, 2022, the Joint Procurement Office will carry out the seventh batch of state-organized drugs.
Centralize the filling and reporting of drug information related to procurement
.
The national procurement involves a total of 208 product specifications, including afatinib oral regular-release dosage form, aripiprazole orally disintegrating tablet, and ondansetron injection
.
.
All drug-related companies:
In order to do a good job in the seventh batch of centralized procurement of drugs organized by the state, further optimize the work process, and establish a normalized working mechanism, starting from February 18, 2022, the Joint Procurement Office will carry out the seventh batch of centralized procurement of drugs organized by the state.
Drug information reporting work , the relevant matters are hereby notified as follows:
Drug information reporting work , the relevant matters are hereby notified as follows:
1.
Drug Requirements
Drug Requirements
Listed drugs that fall within the scope of drug reporting (see the attachment for details) and have obtained a valid domestic registration approval, and meet one of the following requirements:
1.
The original research drug and the reference preparation for the consistency evaluation of the quality and efficacy of the generic drug issued by the State Drug Administration
.
The original research drug and the reference preparation for the consistency evaluation of the quality and efficacy of the generic drug issued by the State Drug Administration
.
2.
Generic drugs that have passed the consistency evaluation of the quality and efficacy of generic drugs by the State Drug Administration
.
Generic drugs that have passed the consistency evaluation of the quality and efficacy of generic drugs by the State Drug Administration
.
3.
According to the "Announcement of the State Food and Drug Administration on Issuing the Work Plan for the Reform of the Registration and Classification of Chemical Drugs" [2016 No.
51] or the "Notice of the State Food and Drug Administration on Issuing the Requirements for the Registration and Application of Chemical Drugs" [2020 Year No.
44], the generic drugs that are approved according to the registration classification of chemical drugs and prove that the quality and efficacy are consistent with the reference preparations
.
According to the "Announcement of the State Food and Drug Administration on Issuing the Work Plan for the Reform of the Registration and Classification of Chemical Drugs" [2016 No.
51] or the "Notice of the State Food and Drug Administration on Issuing the Requirements for the Registration and Application of Chemical Drugs" [2020 Year No.
44], the generic drugs that are approved according to the registration classification of chemical drugs and prove that the quality and efficacy are consistent with the reference preparations
.
4.
Drugs included in the "Catalogue of Chemical Drugs" of the Center for Drug Evaluation of the State Drug Administration
.
Drugs included in the "Catalogue of Chemical Drugs" of the Center for Drug Evaluation of the State Drug Administration
.
2.
Enterprise requirements
Enterprise requirements
Relevant companies that fall within the scope of this drug report and meet the drug requirements include: domestic drug manufacturers that provide drugs and accompanying services, drug marketing authorization holders, and domestic agents of overseas drug marketing authorization holders .
The agent mentioned above refers to the overseas holder who has obtained China's drug registration certificate according to the relevant state department's regulations on the administration of domestic agents of overseas drug marketing authorization holders, and represents them in fulfilling the drug marketing authorization stipulated by laws and regulations .
Enterprise legal person in China with the obligation of the holder .
The agent mentioned above refers to the overseas holder who has obtained China's drug registration certificate according to the relevant state department's regulations on the administration of domestic agents of overseas drug marketing authorization holders, and represents them in fulfilling the drug marketing authorization stipulated by laws and regulations .
Enterprise legal person in China with the obligation of the holder .
3.
Fill in the contents
Fill in the contents
1.
Certification materials (including company name, unified social credit code, contact person, power of attorney, etc.
)
Certification materials (including company name, unified social credit code, contact person, power of attorney, etc.
)
2.
Proof materials that meet the drug requirements (including drug registration approval documents, supplementary registration approval documents, instructions, etc.
)
.
Proof materials that meet the drug requirements (including drug registration approval documents, supplementary registration approval documents, instructions, etc.
)
.
3.
Description of production capacity and self-production of raw materials,
etc.
Description of production capacity and self-production of raw materials,
etc.
Fourth, matters needing attention
1.
How to fill in the form: Please log in to the "Comprehensive Service Platform for Centralized Drug Purchasing of National Organizations " (website: http://pub.
smpaa.
cn/xxsj) for enterprise registration and information filling
.
New users need to select the identity of "Qualification Maintenance User" to register; if there is an existing "Qualification Maintenance User" account, they need to re-submit the qualification documents related to this centralized procurement, and the "variety information" maintenance can be carried out after the review is passed
.
The user account is valid for a long time and does not require repeated registration
.
How to fill in the form: Please log in to the "Comprehensive Service Platform for Centralized Drug Purchasing of National Organizations " (website: http://pub.
smpaa.
cn/xxsj) for enterprise registration and information filling
.
New users need to select the identity of "Qualification Maintenance User" to register; if there is an existing "Qualification Maintenance User" account, they need to re-submit the qualification documents related to this centralized procurement, and the "variety information" maintenance can be carried out after the review is passed
.
The user account is valid for a long time and does not require repeated registration
.
2.
After the approved drug information is confirmed by the enterprise, a "List of Declaration Information" will be generated, which will be used as the basis for the declaration of the seventh batch of centralized drug procurement organized by the state.
Please fill in the relevant information correctly
.
The specific requirements are subject to the provisions of the procurement documents
.
After the approved drug information is confirmed by the enterprise, a "List of Declaration Information" will be generated, which will be used as the basis for the declaration of the seventh batch of centralized drug procurement organized by the state.
Please fill in the relevant information correctly
.
The specific requirements are subject to the provisions of the procurement documents
.
3.
Contact: 021-31773244, 31773255, 31773266
Contact: 021-31773244, 31773255, 31773266
(Service hours 8: 30-11: 30, 13: 30-16: 30, excluding holidays)
hereby notified
.
.
On February 17, Shanghai Sunshine Pharmaceutical Purchasing Network issued the "Notice on Carrying out the Information Reporting of the Seventh Batch of State-Organized Centralized Drug Procurement".
From February 18, 2022, the Joint Procurement Office will carry out the seventh batch of state-organized drugs.
Centralize the filling and reporting of drug information related to procurement
.
From February 18, 2022, the Joint Procurement Office will carry out the seventh batch of state-organized drugs.
Centralize the filling and reporting of drug information related to procurement
.
The national procurement involves a total of 208 product specifications, including afatinib oral regular-release dosage form, aripiprazole orally disintegrating tablet, and ondansetron injection
.
.
All drug-related companies:
All drug-related companies: In order to do a good job in the seventh batch of centralized procurement of drugs organized by the state, further optimize the work process, and establish a normalized working mechanism, starting from February 18, 2022, the Joint Procurement Office will carry out the seventh batch of centralized procurement of drugs organized by the state.
Drug information reporting work , the relevant matters are hereby notified as follows:
Drug information reporting work , the relevant matters are hereby notified as follows:
1.
Drug Requirements
1. Drug Requirements
Drug Requirements
Listed drugs that fall within the scope of drug reporting (see the attachment for details) and have obtained a valid domestic registration approval, and meet one of the following requirements:
1.
The original research drug and the reference preparation for the consistency evaluation of the quality and efficacy of the generic drug issued by the State Drug Administration
.
The original research drug and the reference preparation for the consistency evaluation of the quality and efficacy of the generic drug issued by the State Drug Administration
.
2.
Generic drugs that have passed the consistency evaluation of the quality and efficacy of generic drugs by the State Drug Administration
.
Generic drugs that have passed the consistency evaluation of the quality and efficacy of generic drugs by the State Drug Administration
.
3.
According to the "Announcement of the State Food and Drug Administration on Issuing the Work Plan for the Reform of the Registration and Classification of Chemical Drugs" [2016 No.
51] or the "Notice of the State Food and Drug Administration on Issuing the Requirements for the Registration and Application of Chemical Drugs" [2020 Year No.
44], the generic drugs that are approved according to the registration classification of chemical drugs and prove that the quality and efficacy are consistent with the reference preparations
.
According to the "Announcement of the State Food and Drug Administration on Issuing the Work Plan for the Reform of the Registration and Classification of Chemical Drugs" [2016 No.
51] or the "Notice of the State Food and Drug Administration on Issuing the Requirements for the Registration and Application of Chemical Drugs" [2020 Year No.
44], the generic drugs that are approved according to the registration classification of chemical drugs and prove that the quality and efficacy are consistent with the reference preparations
.
4.
Drugs included in the "Catalogue of Chemical Drugs" of the Center for Drug Evaluation of the State Drug Administration
.
Drugs included in the "Catalogue of Chemical Drugs" of the Center for Drug Evaluation of the State Drug Administration
.
2.
Enterprise requirements
2. Enterprise requirements
Enterprise requirements
Relevant companies that fall within the scope of this drug report and meet the drug requirements include: domestic drug manufacturers that provide drugs and accompanying services, drug marketing authorization holders, and domestic agents of overseas drug marketing authorization holders .
The agent mentioned above refers to the overseas holder who has obtained China's drug registration certificate according to the relevant state department's regulations on the administration of domestic agents of overseas drug marketing authorization holders, and represents them in fulfilling the drug marketing authorization stipulated by laws and regulations .
Enterprise legal person in China with the obligation of the holder .
Acting Acting Acting Acting Regulations and Regulations Enterprise Enterprise EnterpriseThe agent mentioned above refers to the overseas holder who has obtained China's drug registration certificate according to the relevant state department's regulations on the administration of domestic agents of overseas drug marketing authorization holders, and represents them in fulfilling the drug marketing authorization stipulated by laws and regulations .
Enterprise legal person in China with the obligation of the holder .
3.
Fill in the contents
3. Fill in the contents
Fill in the contents
1.
Certification materials (including company name, unified social credit code, contact person, power of attorney, etc.
)
Certification materials (including company name, unified social credit code, contact person, power of attorney, etc.
)
2.
Proof materials that meet the drug requirements (including drug registration approval documents, supplementary registration approval documents, instructions, etc.
)
.
Proof materials that meet the drug requirements (including drug registration approval documents, supplementary registration approval documents, instructions, etc.
)
.
3.
Description of production capacity and self-production of raw materials,
etc.
Description of production capacity and self-production of raw materials,
etc.
Fourth, matters needing attention
Fourth, matters needing attention1.
How to fill in the form: Please log in to the "Comprehensive Service Platform for Centralized Drug Purchasing of National Organizations " (website: http://pub.
smpaa.
cn/xxsj) for enterprise registration and information filling
.
New users need to select the identity of "Qualification Maintenance User" to register; if there is an existing "Qualification Maintenance User" account, they need to re-submit the qualification documents related to this centralized procurement, and the "variety information" maintenance can be carried out after the review is passed
.
The user account is valid for a long time and does not require repeated registration
.
purchase purchase purchaseHow to fill in the form: Please log in to the "Comprehensive Service Platform for Centralized Drug Purchasing of National Organizations " (website: http://pub.
smpaa.
cn/xxsj) for enterprise registration and information filling
.
New users need to select the identity of "Qualification Maintenance User" to register; if there is an existing "Qualification Maintenance User" account, they need to re-submit the qualification documents related to this centralized procurement, and the "variety information" maintenance can be carried out after the review is passed
.
The user account is valid for a long time and does not require repeated registration
.
2.
After the approved drug information is confirmed by the enterprise, a "List of Declaration Information" will be generated, which will be used as the basis for the declaration of the seventh batch of centralized drug procurement organized by the state.
Please fill in the relevant information correctly
.
The specific requirements are subject to the provisions of the procurement documents
.
medicines medicines medicinesAfter the approved drug information is confirmed by the enterprise, a "List of Declaration Information" will be generated, which will be used as the basis for the declaration of the seventh batch of centralized drug procurement organized by the state.
Please fill in the relevant information correctly
.
The specific requirements are subject to the provisions of the procurement documents
.
3.
Contact: 021-31773244, 31773255, 31773266
Contact: 021-31773244, 31773255, 31773266
(Service hours 8: 30-11: 30, 13: 30-16: 30, excluding holidays)
hereby notified
.
.
