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On February 18, the Center for Drug Evaluation of the State Food and Drug Administration issued the "Notice on Publicly Soliciting Opinions on the "Guidelines for the Acceptance and Review of Drug Registration (Trial) (Draft for Comment)".
”, “Guidelines for the Acceptance and Review of Chemical Drug Registration (Draft for Comment)”, “Guidelines for the Acceptance and Review of Biological Products Registration (Draft for Comment)” and other revised drafts to solicit comments
.
”, “Guidelines for the Acceptance and Review of Chemical Drug Registration (Draft for Comment)”, “Guidelines for the Acceptance and Review of Biological Products Registration (Draft for Comment)” and other revised drafts to solicit comments
.
01.
3 points have been revised in common
3 points have been revised in common
The common revisions of Sinochem Biotech are mainly based on the revision and improvement of the original guidelines according to the newly announced laws and regulations.
The common revision points are as follows:
The common revision points are as follows:
1.
Acceptance method:
Acceptance method:
(1) The application form filled in from the offer procedure is adjusted to fill in the application form through the drug business application system of the online office of the Drug Administration
.
.
(2) The formal examination materials are changed from paper version to electronic application materials
.
.
2.
Patent link system
Patent link system
In accordance with the requirements of the "Implementation Measures for the Early Resolution Mechanism for Drug Patent Disputes (for Trial Implementation)", and in accordance with the patent information disclosed on the CDE drug patent information registration platform, a statement is made one by one for the drug patents related to generic drugs (reference drugs, drugs with the same name and the same formula)
.
.
3.
Drug Marketing Authorization Holder System
Drug Marketing Authorization Holder System
Under the MAH system, according to the "Measures for the Supervision and Administration of Drug Production", for the convenience of statistical classification, the "Drug Production License" has added a classification code
.
In order to carry out the review and approval smoothly, corresponding options have been added under "Applicant/Manufacturing Enterprise Certification Documents"
.
.
In order to carry out the review and approval smoothly, corresponding options have been added under "Applicant/Manufacturing Enterprise Certification Documents"
.
02.
4 new items are added to the Guidelines for Acceptance and Review of Chemical Drug Registration
4 new items are added to the Guidelines for Acceptance and Review of Chemical Drug Registration
Except for the General Amendment Office, the Guidelines for the Acceptance and Review of Chemical Drug Registration (Draft for Comment) have been revised accordingly in accordance with the relevant laws and regulations promulgated in recent years such as the Measures for the Administration of Drug Registration.
In addition to the above revisions, the new A few additions:
In addition to the above revisions, the new A few additions:
1.
Newly added under Item 2.
2.
2 of “Requirements for Review of Application Materials”
Newly added under Item 2.
2.
2 of “Requirements for Review of Application Materials”
Item 2.
2.
2 adds "Apply for overseas production of drugs of Category 1 and Category 2 (excluding new indications of Category 2.
4), if the application for listing in China has not yet obtained the certificate of compliance with the drug production quality management standard issued by the overseas regulatory agency.
In the marketing application documents, it should submit a statement that its production plant and packaging plant meet the requirements of the drug production quality management standard, and promise to submit a statement of compliance with the drug production quality issued by the overseas drug management agency in accordance with relevant regulations before the final conclusion of the review is made.
Management Specification Evidence Documents"
.
2.
2 adds "Apply for overseas production of drugs of Category 1 and Category 2 (excluding new indications of Category 2.
4), if the application for listing in China has not yet obtained the certificate of compliance with the drug production quality management standard issued by the overseas regulatory agency.
In the marketing application documents, it should submit a statement that its production plant and packaging plant meet the requirements of the drug production quality management standard, and promise to submit a statement of compliance with the drug production quality issued by the overseas drug management agency in accordance with relevant regulations before the final conclusion of the review is made.
Management Specification Evidence Documents"
.
Comments: This new clause is undoubtedly a new favorable measure for the domestic application of overseas new drugs.
Combined with the simplification and acceleration of the approval procedures for overseas new drugs in the early stage, it can speed up the domestic listing of overseas new drugs and promote the accumulation of drug innovation resources in China
.
Combined with the simplification and acceleration of the approval procedures for overseas new drugs in the early stage, it can speed up the domestic listing of overseas new drugs and promote the accumulation of drug innovation resources in China
.
2.
Item 6 of "Key Points for Review of Application Matters" has been added
Item 6 of "Key Points for Review of Application Matters" has been added
According to the feedback from the industry, and in combination with the current drug registration regulations and technical requirements, under the "Key Points for Review of Application Matters", "6.
Applicants who have not previously held the relevant document numbers of the same variety that have already been on the market, propose that the variety has not been marketed at home and abroad.
For applications for new indications, it is necessary to submit complete application materials in strict accordance with the relevant drug registration regulations and technical requirements.
In addition to the application materials for new indications, other materials that can fully support the listing of the product are also submitted, and there is no need to file a separate application for the same product.
Pharmaceutical applications"
.
Applicants who have not previously held the relevant document numbers of the same variety that have already been on the market, propose that the variety has not been marketed at home and abroad.
For applications for new indications, it is necessary to submit complete application materials in strict accordance with the relevant drug registration regulations and technical requirements.
In addition to the application materials for new indications, other materials that can fully support the listing of the product are also submitted, and there is no need to file a separate application for the same product.
Pharmaceutical applications"
.
Question: This article clarifies that applicants who do not hold the relevant document numbers of the same variety already on the market do not need to apply for new indications twice, but how to determine the registration classification of the registration application in the actual application process?
3.
It is clear that it is necessary to declare and fill in the main information content of the reference preparation
It is clear that it is necessary to declare and fill in the main information content of the reference preparation
The requirements for reference preparations have been further improved, and it is clarified that the reference preparations are selected according to the published information in the "Catalogue of Chemical Generic Drug Reference Preparations" of the State Food and Drug Administration, and the main information content of the reference preparations that need to be declared and filled in the registration process
.
.
4.
Added " Prerequisites for Application and Acceptance of Chemical Drugs in Category 4"
Added " Prerequisites for Application and Acceptance of Chemical Drugs in Category 4"
Added "3.
1.
6 The domestically marketed original research drugs or original research and localized varieties have been included in the "Chemical Generic Drug Reference Preparation Catalog", but due to accessibility and other issues, the preparation applicant chooses the unimported original research published in the reference preparation catalog.
If the drug is to be copied, and the declared indications are consistent with the domestically approved indications, it can be declared and accepted in accordance with the four categories of chemical drugs
.
”
1.
6 The domestically marketed original research drugs or original research and localized varieties have been included in the "Chemical Generic Drug Reference Preparation Catalog", but due to accessibility and other issues, the preparation applicant chooses the unimported original research published in the reference preparation catalog.
If the drug is to be copied, and the declared indications are consistent with the domestically approved indications, it can be declared and accepted in accordance with the four categories of chemical drugs
.
”
Comments: Under the premise that the indications of the declared generic varieties are consistent with the domestically approved indications, even if the indications of the original research varieties are different at home and abroad, the drug registration classification will not be changed due to the different sources of the reference preparations, all of which are based on chemical Class 4 drugs are declared and accepted
.
.
On February 18, the Center for Drug Evaluation of the State Food and Drug Administration issued the "Notice on Publicly Soliciting Opinions on the "Guidelines for the Acceptance and Review of Drug Registration (Trial) (Draft for Comment)".
”, “Guidelines for the Acceptance and Review of Chemical Drug Registration (Draft for Comment)”, “Guidelines for the Acceptance and Review of Biological Products Registration (Draft for Comment)” and other revised drafts to solicit comments
.
”, “Guidelines for the Acceptance and Review of Chemical Drug Registration (Draft for Comment)”, “Guidelines for the Acceptance and Review of Biological Products Registration (Draft for Comment)” and other revised drafts to solicit comments
.
01.
3 points have been revised in common
3 points have been revised in common
The common revisions of Sinochem Biotech are mainly based on the revision and improvement of the original guidelines according to the newly announced laws and regulations.
The common revision points are as follows:
The common revision points are as follows:
1.
Acceptance method:
Acceptance method:
(1) The application form filled in from the offer procedure is adjusted to fill in the application form through the drug business application system of the online office of the Drug Administration
.
.
(2) The formal examination materials are changed from paper version to electronic application materials
.
.
2.
Patent link system
Patent link system
In accordance with the requirements of the "Implementation Measures for the Early Resolution Mechanism for Drug Patent Disputes (for Trial Implementation)", and in accordance with the patent information disclosed on the CDE drug patent information registration platform, a statement is made one by one for the drug patents related to generic drugs (reference drugs, drugs with the same name and the same formula)
.
.
3.
Drug Marketing Authorization Holder System
Drug Marketing Authorization Holder System
Under the MAH system, according to the "Measures for the Supervision and Administration of Drug Production", for the convenience of statistical classification, the "Drug Production License" has added a classification code
.
In order to carry out the review and approval smoothly, corresponding options have been added under "Applicant/Manufacturing Enterprise Certification Documents"
.
.
In order to carry out the review and approval smoothly, corresponding options have been added under "Applicant/Manufacturing Enterprise Certification Documents"
.
02.
4 new items are added to the Guidelines for Acceptance and Review of Chemical Drug Registration
4 new items are added to the Guidelines for Acceptance and Review of Chemical Drug Registration
Except for the General Amendment Office, the Guidelines for the Acceptance and Review of Chemical Drug Registration (Draft for Comment) have been revised accordingly in accordance with the relevant laws and regulations promulgated in recent years such as the Measures for the Administration of Drug Registration.
In addition to the above revisions, the new A few additions:
In addition to the above revisions, the new A few additions:
1.
Newly added under Item 2.
2.
2 of “Requirements for Review of Application Materials”
Newly added under Item 2.
2.
2 of “Requirements for Review of Application Materials”
Item 2.
2.
2 adds "Apply for overseas production of drugs of Category 1 and Category 2 (excluding new indications of Category 2.
4), if the application for listing in China has not yet obtained the certificate of compliance with the drug production quality management standard issued by the overseas regulatory agency.
In the marketing application documents, it should submit a statement that its production plant and packaging plant meet the requirements of the drug production quality management standard, and promise to submit a statement of compliance with the drug production quality issued by the overseas drug management agency in accordance with relevant regulations before the final conclusion of the review is made.
Management Specification Evidence Documents"
.
2.
2 adds "Apply for overseas production of drugs of Category 1 and Category 2 (excluding new indications of Category 2.
4), if the application for listing in China has not yet obtained the certificate of compliance with the drug production quality management standard issued by the overseas regulatory agency.
In the marketing application documents, it should submit a statement that its production plant and packaging plant meet the requirements of the drug production quality management standard, and promise to submit a statement of compliance with the drug production quality issued by the overseas drug management agency in accordance with relevant regulations before the final conclusion of the review is made.
Management Specification Evidence Documents"
.
Comments: This new clause is undoubtedly a new favorable measure for the domestic application of overseas new drugs.
Combined with the simplification and acceleration of the approval procedures for overseas new drugs in the early stage, it can speed up the domestic listing of overseas new drugs and promote the accumulation of drug innovation resources in China
.
Combined with the simplification and acceleration of the approval procedures for overseas new drugs in the early stage, it can speed up the domestic listing of overseas new drugs and promote the accumulation of drug innovation resources in China
.
2.
Item 6 of "Key Points for Review of Application Matters" has been added
Item 6 of "Key Points for Review of Application Matters" has been added
According to the feedback from the industry, and in combination with the current drug registration regulations and technical requirements, under the "Key Points for Review of Application Matters", "6.
Applicants who have not previously held the relevant document numbers of the same variety that have already been on the market, propose that the variety has not been marketed at home and abroad.
For applications for new indications, it is necessary to submit complete application materials in strict accordance with the relevant drug registration regulations and technical requirements.
In addition to the application materials for new indications, other materials that can fully support the listing of the product are also submitted, and there is no need to file a separate application for the same product.
Pharmaceutical applications"
.
Applicants who have not previously held the relevant document numbers of the same variety that have already been on the market, propose that the variety has not been marketed at home and abroad.
For applications for new indications, it is necessary to submit complete application materials in strict accordance with the relevant drug registration regulations and technical requirements.
In addition to the application materials for new indications, other materials that can fully support the listing of the product are also submitted, and there is no need to file a separate application for the same product.
Pharmaceutical applications"
.
Question: This article clarifies that applicants who do not hold the relevant document numbers of the same variety already on the market do not need to apply for new indications twice, but how to determine the registration classification of the registration application in the actual application process?
3.
It is clear that it is necessary to declare and fill in the main information content of the reference preparation
It is clear that it is necessary to declare and fill in the main information content of the reference preparation
The requirements for reference preparations have been further improved, and it is clarified that the reference preparations are selected according to the published information in the "Catalogue of Chemical Generic Drug Reference Preparations" of the State Food and Drug Administration, and the main information content of the reference preparations that need to be declared and filled in the registration process
.
.
4.
Added " Prerequisites for Application and Acceptance of Chemical Drugs in Category 4"
Added " Prerequisites for Application and Acceptance of Chemical Drugs in Category 4"
Added "3.
1.
6 The domestically marketed original research drugs or original research and localized varieties have been included in the "Chemical Generic Drug Reference Preparation Catalog", but due to accessibility and other issues, the preparation applicant chooses the unimported original research published in the reference preparation catalog.
If the drug is to be copied, and the declared indications are consistent with the domestically approved indications, it can be declared and accepted in accordance with the four categories of chemical drugs
.
”
1.
6 The domestically marketed original research drugs or original research and localized varieties have been included in the "Chemical Generic Drug Reference Preparation Catalog", but due to accessibility and other issues, the preparation applicant chooses the unimported original research published in the reference preparation catalog.
If the drug is to be copied, and the declared indications are consistent with the domestically approved indications, it can be declared and accepted in accordance with the four categories of chemical drugs
.
”
Comments: Under the premise that the indications of the declared generic varieties are consistent with the domestically approved indications, even if the indications of the original research varieties are different at home and abroad, the drug registration classification will not be changed due to the different sources of the reference preparations, all of which are based on chemical Class 4 drugs are declared and accepted
.
.
On February 18, the Center for Drug Evaluation of the State Food and Drug Administration issued the "Notice on Publicly Soliciting Opinions on the "Guidelines for the Acceptance and Review of Drug Registration (Trial) (Draft for Comment)".
”, “Guidelines for the Acceptance and Review of Chemical Drug Registration (Draft for Comment)”, “Guidelines for the Acceptance and Review of Biological Products Registration (Draft for Comment)” and other revised drafts to solicit comments
.
”, “Guidelines for the Acceptance and Review of Chemical Drug Registration (Draft for Comment)”, “Guidelines for the Acceptance and Review of Biological Products Registration (Draft for Comment)” and other revised drafts to solicit comments
.
01.
3 points have been revised in common
01. 3 points have been revised in common
3 points have been revised in common
The common revisions of Sinochem Biotech are mainly based on the revision and improvement of the original guidelines according to the newly announced laws and regulations.
The common revision points are as follows:
The common revision points are as follows:
1.
Acceptance method:
1. Acceptance method:
Acceptance method:
(1) The application form filled in from the offer procedure is adjusted to fill in the application form through the drug business application system of the online office of the Drug Administration
.
.
(2) The formal examination materials are changed from paper version to electronic application materials
.
.
2.
Patent link system
2. Patent link system
Patent link system
In accordance with the requirements of the "Implementation Measures for the Early Resolution Mechanism for Drug Patent Disputes (for Trial Implementation)", and in accordance with the patent information disclosed on the CDE drug patent information registration platform, a statement is made one by one for the drug patents related to generic drugs (reference drugs, drugs with the same name and the same formula)
.
.
3.
Drug Marketing Authorization Holder System
3. Drug Marketing Authorization Holder System
Drug Marketing Authorization Holder System
Under the MAH system, according to the "Measures for the Supervision and Administration of Drug Production", for the convenience of statistical classification, the "Drug Production License" has added a classification code
.
In order to carry out the review and approval smoothly, corresponding options have been added under "Applicant/Manufacturing Enterprise Certification Documents"
.
enterprise enterprise enterprise.
In order to carry out the review and approval smoothly, corresponding options have been added under "Applicant/Manufacturing Enterprise Certification Documents"
.
02.
4 new items are added to the Guidelines for Acceptance and Review of Chemical Drug Registration
02. 4 new items are added to the Guidelines for Acceptance and Review of Chemical Drug Registration
4 new items are added to the Guidelines for Acceptance and Review of Chemical Drug Registration
Except for the General Amendment Office, the Guidelines for the Acceptance and Review of Chemical Drug Registration (Draft for Comment) have been revised accordingly in accordance with the relevant laws and regulations promulgated in recent years such as the Measures for the Administration of Drug Registration.
In addition to the above revisions, the new A few additions:
Regulations and RegulationsIn addition to the above revisions, the new A few additions:
1.
Newly added under Item 2.
2.
2 of “Requirements for Review of Application Materials”
1. Newly added under Item 2.
2.
2 of “Requirements for Review of Application Materials”
Newly added under Item 2.
2.
2 of “Requirements for Review of Application Materials”
Item 2.
2.
2 adds "Apply for overseas production of drugs of Category 1 and Category 2 (excluding new indications of Category 2.
4), if the application for listing in China has not yet obtained the certificate of compliance with the drug production quality management standard issued by the overseas regulatory agency.
In the marketing application documents, it should submit a statement that its production plant and packaging plant meet the requirements of the drug production quality management standard, and promise to submit a statement of compliance with the drug production quality issued by the overseas drug management agency in accordance with relevant regulations before the final conclusion of the review is made.
Management Specification Evidence Documents"
.
2.
2 adds "Apply for overseas production of drugs of Category 1 and Category 2 (excluding new indications of Category 2.
4), if the application for listing in China has not yet obtained the certificate of compliance with the drug production quality management standard issued by the overseas regulatory agency.
In the marketing application documents, it should submit a statement that its production plant and packaging plant meet the requirements of the drug production quality management standard, and promise to submit a statement of compliance with the drug production quality issued by the overseas drug management agency in accordance with relevant regulations before the final conclusion of the review is made.
Management Specification Evidence Documents"
.
Comments: This new clause is undoubtedly a new favorable measure for the domestic application of overseas new drugs.
Combined with the simplification and acceleration of the approval procedures for overseas new drugs in the early stage, it can speed up the domestic listing of overseas new drugs and promote the accumulation of drug innovation resources in China
.
Combined with the simplification and acceleration of the approval procedures for overseas new drugs in the early stage, it can speed up the domestic listing of overseas new drugs and promote the accumulation of drug innovation resources in China
.
2.
Item 6 of "Key Points for Review of Application Matters" has been added
2. Item 6 of "Key Points for Review of Application Matters" has been added
Item 6 of "Key Points for Review of Application Matters" has been added
According to the feedback from the industry, and in combination with the current drug registration regulations and technical requirements, under the "Key Points for Review of Application Matters", "6.
Applicants who have not previously held the relevant document numbers of the same variety that have already been on the market, propose that the variety has not been marketed at home and abroad.
For applications for new indications, it is necessary to submit complete application materials in strict accordance with the relevant drug registration regulations and technical requirements.
In addition to the application materials for new indications, other materials that can fully support the listing of the product are also submitted, and there is no need to file a separate application for the same product.
Pharmaceutical applications"
.
drug registration drug registration drug registrationApplicants who have not previously held the relevant document numbers of the same variety that have already been on the market, propose that the variety has not been marketed at home and abroad.
For applications for new indications, it is necessary to submit complete application materials in strict accordance with the relevant drug registration regulations and technical requirements.
In addition to the application materials for new indications, other materials that can fully support the listing of the product are also submitted, and there is no need to file a separate application for the same product.
Pharmaceutical applications"
.
Question: This article clarifies that applicants who do not hold the relevant document numbers of the same variety already on the market do not need to apply for new indications twice, but how to determine the registration classification of the registration application in the actual application process?
3.
It is clear that it is necessary to declare and fill in the main information content of the reference preparation
3. It is clear that it is necessary to declare and fill in the main information content of the reference preparation
It is clear that it is necessary to declare and fill in the main information content of the reference preparation
The requirements for reference preparations have been further improved, and it is clarified that the reference preparations are selected according to the published information in the "Catalogue of Chemical Generic Drug Reference Preparations" of the State Food and Drug Administration, and the main information content of the reference preparations that need to be declared and filled in the registration process
.
.
4.
Added " Prerequisites for Application and Acceptance of Chemical Drugs in Category 4"
4. Added " Prerequisites for Application and Acceptance of Chemical Drugs in Category 4"
Added " Prerequisites for Application and Acceptance of Chemical Drugs in Category 4"
Added "3.
1.
6 The domestically marketed original research drugs or original research and localized varieties have been included in the "Chemical Generic Drug Reference Preparation Catalog", but due to accessibility and other issues, the preparation applicant chooses the unimported original research published in the reference preparation catalog.
If the drug is to be copied, and the declared indications are consistent with the domestically approved indications, it can be declared and accepted in accordance with the four categories of chemical drugs
.
”
1.
6 The domestically marketed original research drugs or original research and localized varieties have been included in the "Chemical Generic Drug Reference Preparation Catalog", but due to accessibility and other issues, the preparation applicant chooses the unimported original research published in the reference preparation catalog.
If the drug is to be copied, and the declared indications are consistent with the domestically approved indications, it can be declared and accepted in accordance with the four categories of chemical drugs
.
”
Comments: Under the premise that the indications of the declared generic varieties are consistent with the domestically approved indications, even if the indications of the original research varieties are different at home and abroad, the drug registration classification will not be changed due to the different sources of the reference preparations, all of which are based on chemical Class 4 drugs are declared and accepted
.
medicines medicines medicines .
