China’s National Medical Products Administration (NMPA) has released the “Vaccine Manufacturing and Distribution Management Measures,” effective immediately. The finalized document includes amendments to a draft proposal from March, addressing pharmacovigilance, personnel requirements, and post-marketing management.
Key Changes
- Packaging and Labeling: The final document mandates that vaccine packaging, labeling, and sub-packaging must be conducted by the vaccine production license holder.
- Outsourced Manufacturing: Special provisions on equity holdings for outsourced production of polyvalent vaccines have been removed.
- Restarting Production: Marketing Authorization Holders (MAHs) must report to provincial Medical Product Administration (MPA) bureaus one month before resuming manufacturing after a long halt.
Overseas MAHs
- Production Site Changes: Overseas MAHs must submit a supplementary application to the Center for Drug Evaluation to change production sites.
Supervision and Management
- Inter-Provincial Coordination: If the MAH and the outsourced production enterprise are in different provinces, the respective provincial MPA bureaus are responsible for supervising their respective entities. Joint inspections may be conducted when necessary.
- Inspector Role: MPA inspectors will support batch-issuing agencies in on-site verification and other tasks.
Export and Import Rules
- Export Compliance: Vaccine manufacturers exporting vaccines must adhere to international procurement requirements.
- Direct Sales: Vaccines for export only must be sold directly to foreign countries and not in China.
- Import Restrictions: Vaccines cannot be re-imported into China after export.-Fineline Info & Tech
