Pharmaceutical Manufacturers: Export Drug Inspection and Export Certificate Regulations
The NMPA has released guidelines outlining the regulatory requirements and inspection processes for pharmaceutical manufacturers exporting drugs. The regulations focus on ensuring quality management, proper documentation, and compliance with domestic and international standards.
Key Highlights:
- Application Form Requirements:
- Must match the enterprise name and domicile on the Drug Production License
- Sections filled according to the importing country requirements and the drug approval certificate
- Marketing Authorization:
- Clarifies if the drug is licensed for domestic use (section 2A) or not (section 2B)
- Manufacturing and Inspection:
- Regular GMP inspections of manufacturing sites, aligned with WHO recommendations
- Export Certificate Details:
- Specifies production address, scope, entrusted production arrangements
- Includes the latest inspection and quality management details
- Export Drug File:
- Must contain importing country, drug name, dosage form, marketing license, quality standards, and production details
Source
Select Mandate HA
Select Mandate Function