Provisions on the Trial Production and On-site Verification of Health Food Samples (Trial)

Provisions on the Trial Production and On-site Inspection of Health Food Samples (Trial)

(Draft for Comments)

Chapter 1: General Provisions

Article 1: To standardize the trial production and on-site verification of health food samples for registration applications, these Regulations are formulated in accordance with the "Measures for the Administration of Health Food Registration."
Article 2: On-site verification of health food sample production or testing refers to the on-site inspection conducted by national or provincial/municipal/regional food and drug regulatory authorities in accordance with prescribed verification content, followed by the issuance of verification opinions.
On-site verification includes safety toxicology studies, functional studies, testing of active and marker ingredients, hygiene studies, and stability studies. Priority is given to verifying the on-site execution of safety toxicology and functional studies.
Article 3: Provincial, autonomous regional, and municipal food and drug administration departments, entrusted by the China Food and Drug Administration, shall verify the pilot production and testing sites for domestic health food registration applications and collect samples for inspection.
The National Medical Products Administration is responsible for verifying the production and trial sites of imported health food applications.

Chapter 2: On-site Inspection Content for Domestic Health Foods

Article 4: Content of on-site verification for sample trial production:
(1) Production qualification certificates on-site for sample trial manufacturing;
(2) Verify the sample's production process against the process flowchart in the application materials.
(3) Source of raw materials and batch records for samples;
(4) Extract samples for testing;
(5) Other items requiring verification.
Article 5: Content of on-site verification for sample testing:
(1) Was the sample test report issued by this inspection agency?
(II) Test reports and test-related records, specifically:
1. Sample acceptance, transfer, and management records;
2. Raw test records;
3. Equipment Usage Log
4. Other content related to the trial.
(3) If necessary, extract samples for testing.
Article 6: The food and drug administration department may simplify the verification content for testing institutions with strict management of trial conduct norms.

Chapter 3: On-site Inspection Procedures for Domestic Health Food

Article 7: On-site verification shall be organized by the food and drug administration department of the province, autonomous region, or municipality where the sample production is conducted. If the sample testing site and the sample production site are located in different provinces, autonomous regions, or municipalities, the on-site verification may be entrusted to the food and drug administration department of the province, autonomous region, or municipality where the testing site is located.
Article 8: The provincial, autonomous regional, or municipal food and drug administration shall organize an on-site inspection within 15 days after accepting the registration application for health food.
Article 9: The on-site verification team shall consist of 2 to 3 members, with one designated as the team leader. Members must be familiar with relevant information in the declaration materials and possess the requisite professional knowledge and on-site verification experience.
Verify.
Article 10: The on-site inspection team shall notify the inspected entity in advance before conducting inspections and must present a written authorization letter issued by the provincial, autonomous region, or municipal food and drug administration department during the inspection.
Article 11: Upon receiving the verification notice, the entity to be verified shall assign a dedicated staff member to assist in the verification process.
Article 12: Verifiers may conduct on-site inspections through interviews, site visits, and review of relevant materials. When necessary, they may photograph or copy the site and documents, and require confirmation from the inspected entity.
Article 13: When the verification team collects samples at trial production or manufacturing sites, they shall randomly select three consecutive batch numbers of products. The sampling quantity must be three times the amount required for testing; the sample volume collected at test sites shall be determined based on the specific test items. After sampling, a seal bearing the official stamp of the sampling unit must be affixed to the outer packaging of each sample, clearly indicating the product name, sealing date, sealer's name, and signatures from the verified entity.
Article 14: During sampling, inspectors shall complete the "On-site Sample Sampling Form" and require the sampled entity to confirm on site.
Article 15: At the conclusion of the on-site verification, verifiers shall issue preliminary findings based on their observations and communicate them to the entity under review. If the entity has objections to the preliminary findings, it may present its statements and defenses on the spot and submit relevant documentation.
After reviewing the inspected unit's feedback, the verification team completes the "Sample Trial/On-site Verification Form" and obtains the unit's signature. The food and drug regulatory authority organizing the verification then formulates its verification opinion based on this information, submits it to the State Food and Drug Administration, and notifies the certification...
The designated inspection agency shall issue an inspection notice, providing test samples and product quality standards.

Chapter IV: Supplementary Provisions