China Profile Updated in ClinRegs

The China profile in ClinRegs now includes the following updates:

• Updated contact information for the regulatory authorities (See Regulatory Authority)
• New online platforms for submitting clinical trial materials (See Regulatory Authority and Submission Process)
• New handling guidelines for the domestic drug and biological product clinical trial applications; imported drug and biological product clinical trial applications; priority review application procedures; and bioequivalence filing (See Scope of Assessment, Submission Process, and Submission Content)
• Clarifying guidance on drug registration classifications (See Scope of Assessment, Submission Process, and Submission Content)
• New good clinical practice requirements (See Ethics Committee, Clinical Trial Lifecycle, Sponsorship, Informed Consent, and Investigational Product topics)
• Updates to the service guides for human genetic resource licenses (See Submission Process and Submission Content, Specimen Import & Export, and Consent for Specimen)
• New guidance on working procedures for review of breakthrough therapeutics (See Submission Process and Timeline of Review)
• New guidance on submission of drug clinical trial data (See Submission Process and Quality, Data & Records Management)
• New regulation on drug clinical trial registration and information disclosure management (See Trial Initiation)
• New regulations for safety information evaluation and management during clinical trials and safety update reports (See Safety Reporting)
• New guidelines for the preservation of essential documents for clinical trials (Quality, Data & Records Management)
• New measures for the supervision and administration of drug production (See Manufacturing & Import and IMP/IND Quality Requirements)