国家食品药品监管总局发布《药品委托生产监督管理规定》 (14/08/2014)

On August 14, 2014, the National  Food  and  Drug Administration  (the  National FDA) published  the Provisions on the Supervision and Administration of Commissioned Production of Drugs (the Provisions), which regulate the application, inspection, permit and supervision of the commissioned production of drugs between domestic drug production enterprises, and became effective October 1, 2014.

Before the Provisions, the commissioned production of drugs was only regulated by the Measures for the Production of Drugs (the Measures), which are considerably general and simple. The Provisions provide a more specific and detailed system of administration and supervision on the commissioned production of drugs, and the key elements of the Provisions are summarized below.

Clarify Definition of Commissioned Production of Drugs

The Provisions provide a clear definition of the commissioned production of drugs, which makes up the deficiency in the Measures. The Provisions define the commissioned production of drugs as the activity of a drug producer (the Principal) commissioning another drug producer (the Agent) to complete the whole process of production of the Principal’s drugs with drug approval numbers under the condition that the Principal is temporarily lacking of production conditions or capability as a result of technical transformation or is temporarily lacking of sufficient production capacity to guarantee the market supply.

Unification of Approval Authority

The Measures provide that depending on the different types of the drugs, the approval authorities of the commissioned production of drugs may vary from the National FDA and the FDA at the provincial level. In the Provisions, the approval authority has been unified to the FDA at the provincial level with an exception that narcotics, psychotropic drugs, precursor chemicals and compound preparations thereof for drugs, medical toxic drugs, biological products, multicomponent biochemical drugs, traditional Chinese medicine injection, and bulk pharmaceutical chemicals shall not be produced on a commissioned basis, and the list for drugs that shall not be produced on a commissioned basis may be adjusted by the National FDA according to practical supervision and administration demand.

Specify Responsibilities of Both Principal and Agent

The Measures only provide that the Agent assumed the commissioned production of drugs should be a drug producer with the certificate of Good Manufacturing Practice for Drugs, which is consistent with the drugs to be produced on a commissioned basis. However, the Provisions provide that both the Agent and the Principal should be the drug production enterprises with the aforesaid certificate. Moreover, the Provisions provide that the Principal is responsible for obtaining the drug production approval number and the quality of drugs produced on a commissioned basis (including carefully examining the production condition, technical level and quality management competence of the Agent, providing the Agent with technical and quality documents for commissioned production of drugs, confirming that the Agent has the condition and ability for commissioned production, and the approval and acceptance of drugs produced on a commissioned basis), and the Agent shall be responsible for performing the quality agreement, effectively controlling the production process, and guaranteeing the drugs and the production process to meet the requirements of registration and Good Manufacturing Practice for Drugs.

Detailed Approval Procedures

In addition to the provisions on the time limits for the approval by the competent FDA in the approval procedures, such as the acceptance of application documents, review of the application, and issuance of the permit which have been specified in the Measures, the Provisions further provide detailed procedures of on-site inspection during the review  of an applicant’s first application for the commissioned production. The Provisions emphasize that the key points of the on-site inspection is to assess the Agent’s production condition, technical level, quality management competence, as well as the consistency to the Principal's drug prescription, production process and quality standard.

Conclusion

The Provisions provide a more specific and complete system of rules to guide the drug production enterprises for the operation of commissioned production of drugs and may manage the commissioned production of drugs more effectively.

  • Provisions on the Supervision and Administration of Commissioned Production of Drugs
  • 《药品委托生产监督管理规定》
  • Issuing authority: China National Food and Drug Administration
  • Date of issuance: August 14, 2014 / Effective date: October 1, 2014