Following the promulgation of the revised Administrative Regulations on the Circulation of Vaccines and Vaccination on April 23, 2016, and the Circular on Implementing the Revised Administrative Regulations on the Circulation of Vaccines and Vaccination on June 13, 2016 by the China Food and Drug Administration (“CFDA”) and the National Health and Family Planning Commission (“NHFPC”), in order to further regularize the cold chain storage and transport of vaccines of Class 2 (“Class 2 Vaccines”), the CFDA and NHFPC recently promulgated on September 1st, 2017, a second Circular on Further Strengthening Supervision and Administration on Circulation of Vaccines to Promote the Supply of Vaccines (Shi Yao Jian Yao Hua Jian [2017] No. 76)(“Second Circular”). 

The Second Circular provides for detailed requirements in five aspects on circulation of Class 2 Vaccines. We summarize below the key requirements for each of the five aspects. 

1. Regularizing Storage and Transport of Class 2 Vaccines and Increasing Efficiency on Delivery of Class 2 Vaccines

(1) Standards The storage and delivery of Class 2 Vaccines shall comply with the Pharmaceutical Good Supply Practice (“Pharmaceutical GSP”), Vaccines Storage and Transport Administration Standards and the Inoculation Working Standards

(2) Channel of supply One vaccine production enterprise can supply Class 2 Vaccines directly to the centers of diseases control (“CDCs”) at county level or entrust an enterprise who has conditions of drug cold chain transport for supply. 

(3) Limitation of number of enterprises in charge of delivery One vaccine production enterprise shall not entrust more than two enterprises to deliver Class 2 Vaccines within the same province, autonomous region or direct-controlled municipality. The enterprises entrusted with the delivery of Class 2 Vaccines may not subcontract others with the delivery thereof. 

(4) Reporting and publication obligations Within 15 days after signature of contracts for entrusting delivery and storage of Class 2 Vaccines, the vaccine production enterprise shall report the information on delivery and storage of Class 2 Vaccines to the local food and drug administration (“FDA”) at the provincial level at the locations where the vaccine production enterprise, the storage enterprise and the CDCs receiving Class 2 Vaccines are located. Within 10 working days after receipt of the reported documents, the local FDA at the provincial level shall publish on its official website the information, including the vaccine production enterprise, types of the Class 2 Vaccines, vaccine delivery enterprises, regional vaccine storage enterprises, validity term of contracts for delivery and storage of Class 2 Vaccines.  

At the same time, vaccine production enterprises shall publish the above information on their own website. 

2. Promoting Establishment of a Whole-process Vaccine Traceability System

(1) The vaccine production enterprise, vaccine delivery and storage enterprises, CDCs and inoculation entities shall use information means to establish a whole-process vaccine traceability system covering the production, storage, transport and use of Class 2 Vaccines.

(2) The foregoing entities shall, when hand over the Class 2 Vaccines, record the information on names, specification, production lot number, quantity, expiry date, manufacturer, delivery enterprise, carrier’s license plate number, start and arrival time, transport temperature record.

3. Strengthening Management on Expiry Date of Class 2 Vaccines

Vaccine production enterprises, vaccine delivery and storage enterprises, CDCs and inoculation entities shall strictly manage the expiry date of Class 2 Vaccines and prevent the expired Class 2 Vaccines from being used.

The manufacturers of Class 2 Vaccines shall ship Class 2 Vaccines according to the production date and ensure that the expiry date is clearly visible on the smallest exterior package of Class 2 Vaccines. The expired Class 2 Vaccines shall be marked with “expired”, stored in isolation and destroyed according to the Second Circular. 

4. Further Improving Procurement of Class 2 Vaccines in a centralized manner

CDCs at the provincial level shall include the procurement of Class 2 Vaccines in public trading platforms and determine the purchase price through public tender procedure. 

5. Strengthening Supervision and Inspection on Circulation of Class 2 Vaccines

Local FDAs and HFPCs are required to cooperate with each other to carry out various inspections on the transport, storage and delivery of Class 2 Vaccines, including but not limited to unannounced inspection according to the Drugs and Medical Devices Unannounced Inspection Measures