Research on drug marketing authorization system design based on revision of the drug administration law / 中国药学杂志

ABSTRACT

OBJECTIVE: To put forward some suggestions on drug marketing authorization system design for the revision of Drug Administration Law. METHODS: Compared the difference for drug marketing authorization system design of China, the US and EU, analyzed the advantage of the marketing authorization system of the US and EU; RESULTS AND CONCLUSION: Presented 4 key elements for drug marketing authorization system, put forward that to allow applicant and applicant holder change, remove the binding between marketing authorization and manufacturer, strengthen responsibilities and obligations for applicant and applicant holder's safety and efficiency assurance during the entire life cycle of the drug, and for manufacturers and distributors' quality assurance and implementing supply chain traceability.