MOFCOM Releases Pharmaceutical Registration Guide (2026 Edition)

The Ministry of Commerce (MOFCOM) recently released “the Export Commodity Technical Guide – Pharmaceutical Registration (2026 Edition)”, revised by the China Chamber of Commerce for Import and Export of Medicines and Health Products. This is the third update since the guide was first published in 2009, covering complete registration frameworks for the US, EU, UK, Japan, Brazil, and the WHO prequalification system.

The revised edition covers FDA registration pathways and ANDA/NDA requirements, EMA centralized and mutual recognition procedures, the UK MHRA independent registration system, Japan PMDA processes, Brazil ANVISA requirements, and WHO prequalification.

For pharmaceutical production solution providers like us, registration compliance is a core component of supply chain services. The guide provides clear technical pathways for product registration across different markets, helping companies stay updated on regulatory changes and reduce compliance risks in the registration process.

As a production solution provider with nearly 30 years of experience in the chemical and pharmaceutical sector, we leverage our deep understanding of markets including India, Latin America, Africa, Eastern Europe and Southeast Asia to offer one-stop solutions covering product supply, technical and regulatory registration support, and full supply chain services. The release of this updated guide will serve as an important reference for further enhancing our registration compliance service capabilities.

Full Guide (Chinese): http://www.mofcom.gov.cn/ckzn/yaopinzhuce.shtml

Source: MOFCOM Export Commodity Technical Guide – Pharmaceutical Registration (2026 Edition)

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