- Manufacturers that produce FSMPs should obtain a specific production license.
- Sub-packaging is banned for FSMP production as well.
On January 26th, 2017, CFDA released a draft of Food for Special Medical Purpose Production License Inspection Details (hereafter called Inspection Details) for public consultation. The consultation deadline will be February 28th.
Major highlights are as followed:
- FSMP manufacturers should have full production and processing capacities, i.e. the ability to produce a finished product. Subpackaging/OEM FSMP production is banned.
- Before the manufacturers apply for the production license, their FSMP products should be registered with CFDA. Product registration certificate should be provided when applying for production license.
- In certain circumstances an overlap may exist between the compliance assessment items used by authorities during production inspection and onsite inspection. Items that have already been inspected during one of these assessments do not require secondary inspection and thus a single assessment is sufficient to meet FSMP registration application criteria.
- The onsite inspection will be conducted and assessed using a rating system. The judging criteria are detailed in Article 41 of General Rules for Food Production License Inspection.