How to Register Drugs in China

Content

• 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
  • 1.7 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
      • 1.8.2.1 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
      • 1.8.3.1 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
• 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    • 2.2.1 The withdrawn articles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
      • 2.2.1.2 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
    • 2.2.2 New articles
      • 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
      • 2.2.3.1 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
• 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
      • 3.10.2.1 Clinical trial application
      • 3.10.2.2 Prodution application
    • 3.10.3 Imported drug
      • 3.10.3.1 Clinical Trial application
      • 3.10.3.2 Importation application
    • 3.10.4 Supplementary application of drugs made in China
      • 3.10.4.1 Clinical trial application
      • 3.10.4.2 Production application
    • 3.10.5 Supplementary application of imported drugs
      • 3.10.5.1 Clinical trial 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
    • 4.2.1 Clinical trial requirements
    • 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
    • 4.2.4 Responsibilities of principal investigator and participating institutions
    • 4.2.5 Suspension or cessation of the clinical trial
  • 4.3 Special approval
  • 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
    • 4.5.1 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
  • 4.9 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
      • 5.1.9.1 GMP certificate
      • 5.1.9.2 Company certificate
      • 5.1.9.3 Patent certificate
    • 5.1.10 Certificate of the application agent
    • 5.1.11 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
    • 5.1.15 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 drug
  • 5.2 Repackaging of imported drugs
    • 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
• 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
      • 6.1.2.1 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
    • 6.1.4 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
    • 6.2.1 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
      • 6.2.5.1 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
    • 6.2.7 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
• 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
    • 12.2.1 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
• 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
    • 13.2.1 Application Information Items
    • 13.2.2 Notes
  • 13.3 The application material table and its explanation for TCM and natural drugs
    • 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
  • 14.4 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
  • 14.6 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
    • 14.7.1 Requirement of information items
    • 14.7.2 Notes to the information items
    • 14.7.3 Requirement of clinical study
    • 14.7.4 Definition
• 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
      • 15.1.3.1 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)
    • 15.1.4 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
    • 15.2.1 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
• 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
  • 16.3 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