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Drug Registration in China
A comprehensive overview of procedures
| Publication Date | September 2008 |
| ISBN | 978-1-905751-10-5 |
| Pages | 148 |
| Tables | n/a |
| Figures | n/a |
Print £520 $820 |
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PDF £495 $780 Single user |
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Provides comprehensive insight into China's 2007 revised pharmaceutical regulations
The revised Drug Registration Procedure was introduced on 10 July 2007, coming into effect on 1 October 2007, at which point some changes were made to the current practice, as there were loopholes in the previous regulations. The new regulation comprises 15 chapters with 177 articles, having previously been 16 chapters and 211 articles.
The main revisions to the regulations include provisions to:
- Strengthen the safety requirements for the drug.
- Specify the responsibility and strengthen the supervisory system.
- Increase registration standards and to encourage novel drug research.
In recognition of this major regulatory change in the ever-growing Chinese pharmaceutical market, URCH Publishing presents Drug Registration in China: A comprehensive overview of procedures, a 51,000 word report that clearly and comprehensibly provides a detailed overview of the procedures necessary to register a medicines in the Chinese market.
Starting with an explanation for the key changes to drug registration procedure in 2007 the 148 page report includes details on the new regulatory articles including:
- State Food and Drug Administration (SFDA)
- The openness policy and greater responsibilities of the SFDA
- Definition of re-registration and its procedures
- National economic policy
- Manufacturing process management
- Clinical trial supervision
- Dosage Form Change application requirements
- One-time submission of dossier
- More requirements of Drug Control Institute and CDE
- Clear responsibility for NICPBP during drug importation
- Drug name, packet insert and labels
- Non-approval of new drug application during re-consideration
- New penalty (fines and credit system)
- Situation to revoke the drug approval numbers.
- Full explanation of the drug registration procedure and regulations governing the process
- An outline of the major responsibilities the State Food and Drug Administration (SDFA)
- In-depth analysis of the regulations surrounding the drug registration for imported drugs.
- Comprehensive detail on applications for biologics, Chinese medicines, generics, imported medicines, OTCs, and supplementary products.
- Summary of requirements for the application material for Traditional Chinese Medicines and natural drugs
- Foreign drug companies considering a market entry in China
- Individuals with an interest in understanding the latest Chinese regulations on application and approval for imported drug registration.
- Regulatory affairs professions with responsibility for China
- The report will also be an essential reference document for any company library.
1. GENERAL COMPARISION OF CHINA DRUG REGISTRATION PROCEDURES
1.1 Great expansion of the Chinese pharmaceutical industry
1.2 Increasing trend of multinational trials in China
1.3 SFDA and corruption
1.4 Series of large-scale serious adverse drug reactions (SADRs) occurring in recent years
1.5 The revision of Chinese drug registrations
1.5.1 Temporary Drug Registration (2002)
1.5.2 Drug Registration Procedure (2005)
1.5.3 Drug Registration Procedure (2007)
1.6 Background on the revision of regulation in 2007 1.5.2 Drug Registration Procedure (2005)
1.5.3 Drug Registration Procedure (2007)
1.7 Amendment process
1.8 Significant changes
1.8.1 Encouragement of novel drugs
1.8.1.1 Change of fast-track review to special review.
1.8.1.2 Decrease of the new drug scope.
1.8.1.3 Separation of the New Drug Certificate from the New Drug Production Approval
1.8.1.4 Change of drug application with national standard to generic drug application
1.8.2 Continuous monitoring of drug safety 1.8.1.2 Decrease of the new drug scope.
1.8.1.3 Separation of the New Drug Certificate from the New Drug Production Approval
1.8.1.4 Change of drug application with national standard to generic drug application
1.8.2.1 Strengthening the responsibility of applicant on the drug quality.
1.8.2.2 Strengthening the authenticity check of the submission documents & on-site GMP inspection
1.8.2.3 Drug sampling changed from 'static' to 'dynamic'
1.8.3 Punishment for the applicant for fake submission 1.8.2.2 Strengthening the authenticity check of the submission documents & on-site GMP inspection
1.8.2.3 Drug sampling changed from 'static' to 'dynamic'
1.8.3.1 Fines
1.8.3.2 The effect on the qualification of the applicant
1.8.3.3 Credit system
1.8.4 New system restriction for SFDA drug review process 1.8.3.2 The effect on the qualification of the applicant
1.8.3.3 Credit system
2. MAIN CHANGES IN DRUG REGISTRATION PROCEDURES (2007)
2.1 Major changes
2.2 Details of the change
2.2.1 The withdrawn articles
2.2.1.1 Fasttrack for emergency use
2.2.2 New articles 2.2.1.2 PDA responsibilities
2.2.1.3 Situation for study termination by the SFDA
2.2.1.4 Rejection of repeated new drug application
2.2.1.5 Revocation of application due to unacceptable drug standard
2.2.1.6 New Drug Technology Transfer
2.2.1.7 Transfer of Temporary Drug Standards to Formal Standards
2.2.1.3 Situation for study termination by the SFDA
2.2.1.4 Rejection of repeated new drug application
2.2.1.5 Revocation of application due to unacceptable drug standard
2.2.1.6 New Drug Technology Transfer
2.2.1.7 Transfer of Temporary Drug Standards to Formal Standards
2.2.2.1 Openness policy, hearing meeting system and greater responsibilities of the SFDA
2.2.2.2 Definition of re-registration and its procedures
2.2.2.3 National economic policy
2.2.2.4 Manufacturing process management
2.2.2.5 Clinical trial supervision
2.2.2.6 Dosage Form Change application requirements
2.2.2.7 One-time submission of dossier
2.2.2.8 More requirements of Drug Control Institute and CDE
2.2.2.9 Clear responsibility for NICPBP during drug importation
2.2.2.10 Drug name, packet insert and labels
2.2.2.11 Non-approval of new drug application during re-consideration
2.2.2.12 New penalty (fines and credit system)
2.2.2.13 Situation to revoke the drug approval numbers
2.2.3 Amended articles 2.2.2.2 Definition of re-registration and its procedures
2.2.2.3 National economic policy
2.2.2.4 Manufacturing process management
2.2.2.5 Clinical trial supervision
2.2.2.6 Dosage Form Change application requirements
2.2.2.7 One-time submission of dossier
2.2.2.8 More requirements of Drug Control Institute and CDE
2.2.2.9 Clear responsibility for NICPBP during drug importation
2.2.2.10 Drug name, packet insert and labels
2.2.2.11 Non-approval of new drug application during re-consideration
2.2.2.12 New penalty (fines and credit system)
2.2.2.13 Situation to revoke the drug approval numbers
2.2.3.1 Change of fasttrack review to special review
2.2.3.2 Expanded qualification of the applicant
2.2.3.3 The enlarge scope of drug application
2.2.3.4 Change of drug application with National Standards to generic drug application
2.2.3.5 Simplification of management in patent issue
2.2.3.6 Clinical trial requirements
2.2.3.7 No products will be sampled by PDA, except for biological product
2.2.3.8 Certificate of Analysis (COA) test report will not copy to PDA
2.2.3.9 Definition of supplementary application
2.2.3.10 Imported drug supplementary application
2.2.3.11 National drug standard
2.2.3.12 Shorter timeline in clinical trial approval, and extended timeline to new drug production and generic drug application approvals
2.2.3.2 Expanded qualification of the applicant
2.2.3.3 The enlarge scope of drug application
2.2.3.4 Change of drug application with National Standards to generic drug application
2.2.3.5 Simplification of management in patent issue
2.2.3.6 Clinical trial requirements
2.2.3.7 No products will be sampled by PDA, except for biological product
2.2.3.8 Certificate of Analysis (COA) test report will not copy to PDA
2.2.3.9 Definition of supplementary application
2.2.3.10 Imported drug supplementary application
2.2.3.11 National drug standard
2.2.3.12 Shorter timeline in clinical trial approval, and extended timeline to new drug production and generic drug application approvals
3. GENERAL REQUIREMENTS & APPLICATION PROCEDURES
3.1 National encouragement policy
3.2 Responsibilities of the SFDA and provincial drug administrations
3.3 Openness policy and hearing meeting system
3.4 Registration classification
3.5 The applicant qualification
3.6 To whom is the application submitted?
3.7 Submission documents requirements
3.8 Patent issue
3.9 Undisclosed data issue
3.10 Application procedures
3.10.1 Drugs made in China
3.10.1.1 Clinical trial application
3.10.1.2 Drug production application
3.10.2 Generic drug application approval 3.10.1.2 Drug production application
3.10.2.1 Clinical trial application
3.10.2.2 Prodution application
3.10.3 Imported drug 3.10.2.2 Prodution application
3.10.3.1 Clinical Trial application
3.10.3.2 Importation application
3.10.4 Supplementary application of drugs made in China 3.10.3.2 Importation application
3.10.4.1 Clinical trial application
3.10.4.2 Production application
3.10.5 Supplementary application of imported drugs 3.10.4.2 Production application
3.10.5.1 Clinical trial application
3.10.5.2 Product registation application
3.10.5.2 Product registation application
4. DRUG RESEARCH AND REGISTRATION
4.1 Pre-clinical research
4.1.1 Research contents
4.1.2 Requirements of research institution
4.1.3 Contracting research
4.1.4 Research material of pre-clinical documents by a foreign drug research institution
4.1.5 Repeat experiments
4.1.6 Technology requirements
4.2 Clinical research 4.1.2 Requirements of research institution
4.1.3 Contracting research
4.1.4 Research material of pre-clinical documents by a foreign drug research institution
4.1.5 Repeat experiments
4.1.6 Technology requirements
4.2.1 Clinical trial requirements
4.2.2 Clinical trial
4.2.4 Responsibilities of principal investigator and participating institutions
4.2.5 Suspension or cessation of the clinical trial
4.3 Special approval 4.2.2 Clinical trial
4.2.2.1 Phases of clinical trial
4.2.2.2 Patient number requirement
4.2.2.3 Exception
4.2.3 Responsibilities of the applicant 4.2.2.2 Patient number requirement
4.2.2.3 Exception
4.2.4 Responsibilities of principal investigator and participating institutions
4.2.5 Suspension or cessation of the clinical trial
4.4 New drug application
4.4.1 Co-research for an application
4.4.2 New drug application for drug dosage form change
4.4.3 Dossier requirements if the ingredient is marketed in China or other countries
4.4.4 No supplementary document is allowed during the SFDA review procedure
4.5 Approval of new drug clinical trial 4.4.2 New drug application for drug dosage form change
4.4.3 Dossier requirements if the ingredient is marketed in China or other countries
4.4.4 No supplementary document is allowed during the SFDA review procedure
4.5.1 Withdrawal of application
4.6 Approval of new drug production 4.7 Drug specification
4.8 Management of drugs in monitoring period
4.8.1 The establishment of the monitoring period
4.8.2 Responsibility of the manufacturer of the monitored drugs
4.8.3 Another trial has been approved when a drug is in monitoring period
4.8.4 Another trial of application is submitted, but not approved yet
4.8.5 Imported drug monitoring period
4.8.2 Responsibility of the manufacturer of the monitored drugs
4.8.3 Another trial has been approved when a drug is in monitoring period
4.8.4 Another trial of application is submitted, but not approved yet
4.8.5 Imported drug monitoring period
4.9 Investigational product
4.9.1 The inspection of pilot drug
4.9.2 Management of the pilot drug
5. IMPORTED DRUG REGISTRATION
5.1 The registration of imported drug
5.1.1 Definition
5.1.2 Applicant of the imported drug
5.1.3 Application agent requirements
5.1.4 Classification of imported drug
5.1.6 To whom to apply?
5.1.7 The approving procedure of imported drug
5.1.8 Requirements for imported of chemical drugs
5.1.9 Certificates
5.1.11 Special requirements of packet insert of the imported drugs
5.1.12 Clinical research approval procedure for imported drugs
5.1.13 General clinical research rules for imported drug
5.1.15 Supplementary applications of imported drugs
5.2 Repackaging of imported drugs 5.1.2 Applicant of the imported drug
5.1.3 Application agent requirements
5.1.4 Classification of imported drug
5.1.6 To whom to apply?
5.1.7 The approving procedure of imported drug
5.1.8 Requirements for imported of chemical drugs
5.1.9 Certificates
5.1.9.1 GMP certificate
5.1.9.2 Company certificate
5.1.9.3 Patent certificate
5.1.10 Certificate of the application agent 5.1.9.2 Company certificate
5.1.9.3 Patent certificate
5.1.11 Special requirements of packet insert of the imported drugs
5.1.12 Clinical research approval procedure for imported drugs
5.1.13 General clinical research rules for imported drug
5.1.13.1 Clinical research rules and patient number requirements for imported chemical drugs
5.1.13.2 Clinical trial rule for imported preventive bio-products
5.1.13.3 Clinical trial rule for imported therapeutic bio-products
5.1.14 Re-registration procedure for imported drugs 5.1.13.2 Clinical trial rule for imported preventive bio-products
5.1.13.3 Clinical trial rule for imported therapeutic bio-products
5.1.15 Supplementary applications of imported drugs
5.1.15.1 The approval procedure for supplementary applications
5.1.15.2 The supplementary application classification for an imported drug
5.1.16 Situations that will result in the non-approval of an imported drug5.1.15.2 The supplementary application classification for an imported drug
5.2.1 Definition
5.2.2 Regulatory requirements to approve the repackaging
5.2.3 Procedure to apply for repackaging
5.2.4 Drug standard and package insert sheet
5.2.5 The responsibility of foreign companies
5.2.6 Responsibilities undertaken by a foreign manufacturer
5.2.7 Other relevant provisions
5.3 International multinational clinical trial 5.2.2 Regulatory requirements to approve the repackaging
5.2.3 Procedure to apply for repackaging
5.2.4 Drug standard and package insert sheet
5.2.5 The responsibility of foreign companies
5.2.6 Responsibilities undertaken by a foreign manufacturer
5.2.7 Other relevant provisions
6. GENERIC DRUG APPLICATION AND SUPPLEMENTARY APPLICATION
6.1 Generic drug application
6.1.1 Definition
6.1.2 Barrier to submission of generic drug application is changed
6.1.4 Responsibility of the PDA
6.1.5 Responsibility of the SFDA
6.1.6 Generic drug that will be not approved
6.2 Supplementary application 6.1.2 Barrier to submission of generic drug application is changed
6.1.2.1 Approval timeline prolonged
6.1.2.2 Technology requirement for simplified dosage formulation change is improved
6.1.2.3 Technology requirement for generic drug application is improved
6.1.3 How to submit the generic drug application 6.1.2.2 Technology requirement for simplified dosage formulation change is improved
6.1.2.3 Technology requirement for generic drug application is improved
6.1.4 Responsibility of the PDA
6.1.5 Responsibility of the SFDA
6.1.6 Generic drug that will be not approved
6.2.1 Definition
6.2.2 How to submit supplementary application
6.2.3 Classification of supplementary application
6.2.4 Application procedures
6.2.5 Approval of supplementary application
6.2.7 Imported drug supplementary application
6.2.8 Other situations
6.2.2 How to submit supplementary application
6.2.3 Classification of supplementary application
6.2.4 Application procedures
6.2.5 Approval of supplementary application
6.2.5.1 Supplemental applications to be approved by SFDA
6.2.5.2 Supplemental applications to be approved by PDA and be filed for record at SFDA, or directly be filed for record at SFDA
6.2.5.3 Supplemental applications to be filed for record at PDA
6.2.6 Approval conclusion: approval of supplementary application 6.2.5.2 Supplemental applications to be approved by PDA and be filed for record at SFDA, or directly be filed for record at SFDA
6.2.5.3 Supplemental applications to be filed for record at PDA
6.2.7 Imported drug supplementary application
6.2.8 Other situations
7. OTC DRUG APPLICATION
7.1 Definition
7.2 Drugs that could be applied for as OTC during submission
7.3 Packet insert sheet and labelling
7.4 Imported drug to apply for an OTC
8. THE RE-REGISTRATION OF A DRUG
8.1 Law sources
8.2 Definition
8.3 Drugs needing re-registration
8.4 Time limit
8.5 Application process
8.6 The re-registration will not be accepted
8.7 The application material
8.7.1 Drugs made in China
8.7.2 Imported drugs
8.7.2 Imported drugs
9. DRUG REGISTRATION INSPECTION
9.1 Drug registration inspection
9.2 Testing scope
9.3 Testing institution
9.4 Responsibilities of the applicant
9.5 The responsibilities of the drug inspection institution
9.6 Timeline
10. DRUG REGISTRATION STANDARDS, NAMING AND LABELLING
10.1 Drug registration standards
10.2 Drug standard substance
10.3 Drug name, packet insert sheets and labels
11. RECONSIDERATION OF DRUG REGISTRATION APPLICATION
11.1 Situations for non-approval by SFDA
11.2 Re-consideration procedure
12. LIABILITIES
12.1 Regulatory authority liabilites
12.1.1 Liability 1
12.1. 2 Liability 2
12.1.3 Liability 3
12.2 Applicant liabilities 12.1. 2 Liability 2
12.1.3 Liability 3
12.2.1 Fines
12.2.2 The effect on the qualification of applicant
12.2.3 Credit system
12.2.4 Situations to revoke the drug approval number
12.2.2 The effect on the qualification of applicant
12.2.3 Credit system
12.2.4 Situations to revoke the drug approval number
13. THE APPLICATION MATERIAL REQUIREMENTS OF TCM AND NATURAL DRUGS
13.1 Registration categories and notes
13.1.1 Registration categories
13.1.2 Notes
13.2 Application information items and notes 13.1.2 Notes
13.2.1 Application Information Items
13.2.2 Notes
13.3 The application material table and its explanation for TCM and natural drugs 13.2.2 Notes
13.3.1 Table of application information item for TCM and natural drugs
14. APPLICATION MATERIAL REQUIREMENTS FOR A CHEMICAL DRUG
14.1 Registration category
14.2 Application dossier items
14.2.1 Summary
14.2.2 Pharmaceutical data
14.2.3 Pharmacology and toxicology study information
14.2.4 Clinical study information
14.3 Notes to Application Information Items 14.2.2 Pharmaceutical data
14.2.3 Pharmacology and toxicology study information
14.2.4 Clinical study information
14.4 Table of application information item and notes
14.4.1 Table of application information item
14.4.2 Notes
14.5 Requirement for clinical study 14.4.2 Notes
14.6 Requirement for am imported chemical drug
14.6.1 Requirement of application information items
14.6.2 Requirement and notes to Information Item 2, certified documents
14.6.3 Requirement for the clinical study conducted in China
14.7 Application information and requirement for radioactive drugs 14.6.2 Requirement and notes to Information Item 2, certified documents
14.6.3 Requirement for the clinical study conducted in China
14.7.1 Requirement of information items
14.7.2 Notes to the information items
14.7.3 Requirement of clinical study
14.7.4 Definition
14.7.2 Notes to the information items
14.7.3 Requirement of clinical study
14.7.4 Definition
15. APPLICATION MATERIAL REQUIREMENTS FOR BIOLOGICAL PRODUCTS
15.1 Section 1 - therapeutic biological product
15.1.1 Classification
15.1.2 Application information items
15.1.3 Requirement of the application information
15.1.4 Notes to the application information
15.1.5 Notes to the clinical study
15.1.6 Application information and requirement for imported therapeutic biological products
15.2.1 Registration categories
15.2.2 Application Information Items
15.2.3 Application information items table
15.2.4 Notes to the Application Information Items
15.2.5 Notes to the clinical study
15.2.6 Application information and requirement for imported preventive biological products
16. APPLICATION MATERIAL AND REQUIREMENTS OF SUPPLEMENTARY APPLICATION
16.1 Registration classification
16.3 Table of application information items
16.4 Notes and relevant requirement of the registration items and application information items
17. APPLICATION MATERIAL FOR RE-REGISTRATION
17.1 Drugs made in China
17.2 Imported drugs
18. TIMEFRAME FOR MONITORING PERIOD OF NEW DRUGS
(NOTE: NO MONITORING PERIOD WILL BE ESTABLISHED FOR DRUGS OTHER THAN THOSE LISTED) (TABLES 1-3)
18.1 A 5-year monitoring period will be established for new drugs listed in Table 1
18.2 A 4-year monitoring period will be established for new drugs listed in Table 2
18.3 A 3-year monitoring period will be established for the new drugs listed in Table 3
15.1.2 Application information items
15.1.3 Requirement of the application information
15.1.3.1 Table of Application Information Items for therapeutic biological products, (Information Items 1-15, 29-38)
15.1.3.2 Table of Application Information Items for
pharmacology and toxicology information for therapeutic biological product (Information Items 14-29) 15.1.3.2 Table of Application Information Items for
15.1.4 Notes to the application information
15.1.5 Notes to the clinical study
15.1.6 Application information and requirement for imported therapeutic biological products
15.1.6.1 Requirement for application information items
15.1.6.2 Requirement and notes to the Information Item 2, certified documents
15.1.6.3 Requirement for other information items
15.1.6.4 Requirements for clinical study conducted in China
15.2 Preventive biological products 15.1.6.2 Requirement and notes to the Information Item 2, certified documents
15.1.6.3 Requirement for other information items
15.1.6.4 Requirements for clinical study conducted in China
15.2.1 Registration categories
15.2.2 Application Information Items
15.2.3 Application information items table
15.2.4 Notes to the Application Information Items
15.2.5 Notes to the clinical study
15.2.6 Application information and requirement for imported preventive biological products
15.2.6.1 Requirement with information items
15.2.6.2 Requirement and notes to the Information Item 1 (ii), certified documents
15.2.6.3 Requirement for other information items
15.2.6.4 Requirements for clinical studies conducted in China
15.2.6.2 Requirement and notes to the Information Item 1 (ii), certified documents
15.2.6.3 Requirement for other information items
15.2.6.4 Requirements for clinical studies conducted in China
16. APPLICATION MATERIAL AND REQUIREMENTS OF SUPPLEMENTARY APPLICATION
16.1 Registration classification
16.1.1 Supplemental applications to be approved by SFDA
16.1.2 Supplementary applications to be approved by PDA and be filed for record at SFDA, or directly be filed for record at SFDA
16.1.3 Supplemental applications to be filed for record at PDA
16.2 Application information items 16.1.2 Supplementary applications to be approved by PDA and be filed for record at SFDA, or directly be filed for record at SFDA
16.1.3 Supplemental applications to be filed for record at PDA
16.3 Table of application information items
16.4 Notes and relevant requirement of the registration items and application information items
17. APPLICATION MATERIAL FOR RE-REGISTRATION
17.1 Drugs made in China
17.2 Imported drugs
18. TIMEFRAME FOR MONITORING PERIOD OF NEW DRUGS
(NOTE: NO MONITORING PERIOD WILL BE ESTABLISHED FOR DRUGS OTHER THAN THOSE LISTED) (TABLES 1-3)
18.1 A 5-year monitoring period will be established for new drugs listed in Table 1
18.2 A 4-year monitoring period will be established for new drugs listed in Table 2
18.3 A 3-year monitoring period will be established for the new drugs listed in Table 3