China Publishes Vaccine Manufacture & Distribution Rules with Immediate Effect

by Grace Wang Jul 14, 2022

On July 8, China National Medical Products Administration (NMPA) released the Administrative Rules on Vaccine Manufacture and Distribution (hereafter referred to as the Rules) with immediate effect.

According to the Rules, China adopts marketing authorization holder (MAH) system for vaccines. MAHs shall take the primary responsibilities for vaccine's safety, efficacy, and quality controllability, and manage the manufacture and distribution of vaccines after obtaining marketing authorization.1

The Rules applies to the vaccine's manufacture, distribution, and supervision in China. Since overseas companies cannot entrust vaccine production activities to Chinese manufacturers, the manufacturing requirements in the Rules only apply to Chinese MAHs.

As for vaccine distribution, overseas MAHs should obey the following requirements:

The Sales of Vaccines:

1. Overseas MAHs shall sell vaccines to disease prevention & control institutions as per purchase contracts. In principle, for one type of vaccines, overseas MAHs shall appoint only one drug supplier company to sell them. The supplier should be fully capable of ensuring the vaccine's quality with cold chains.

2. When the imported vaccines are found with severe deviations that may affect quality or with severe quality issues, the domestic agent appointed by the overseas MAH shall report to the provincial medical products administration of where the import port is. The report shall include at least the following information:

  • The details of the severe deviation or quality issues;

  • The involved vaccine's name, approval number, specification, quantity, distribution channel, etc.

  • The existing or potential adverse effects.

  • The following measures the MAH plans to take.

  • Other information that need to be specified.

3. MAHs shall keep authentic, accurate, and complete sale records, which should at least include:

  • The generic name of the vaccine;

  • Approval code;

  • Batch number;

  • Valid period;

  • The purchaser's organization;

  • Sales volume;

  • Unit price;

  • Sales value;

  • Sales date;

  • The MAH's information.

MAHs should also take records of entrusted storage and transport. All the records should be kept for at least 5 years after the vaccines become expired.

The Delivery of Vaccines:

1. If the MAH or the disease prevention & control institution delivers vaccines by themselves, they should meet the cold chain storage and transport conditions and requirements. The purchase contract between the MAH and the disease prevention & control institution shall specify the following information:

  • The organization which carries out the delivery task;

  • Delivery method;

  • Delivery time limit;

  • Receiver's address.

2. MAHs can entrust other companies to store and deliver the vaccines if the entrusted companies meet the Good Supply Practice's refrigeration requirements for storage and transport. MAHs should evaluate the capacity and control the number of the entrustees, which should be no more than two in one administrative provincial area.

The Traceability of Vaccines:

1. If entrusting delivery to a third party, the MAH shall report the information of the entrustee's storage, transport, and information traceability capacity to the provincial medical products administration of where the delivery destination is.

2. MAHs, disease prevention & control institutions, and entrusted storage/delivery companies shall take records of vaccine's sales, storage, transport, and usage to ensure that vaccines in the minimum packaging units are traceable from production to use.

For other regulatory requirements concerning vaccines, you're welcomed to consult BaiPharm for professional answers and solutions.

Grace Wang
ChemLinked Regulatory Analyst
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