China urgently needed drugs temporary import workflow was issued on June 29, 2022, by the National Health Commission (NHC) and the National Medical Products Administration (NMPA).
Scope of application
The workflow applies to urgently needed drugs in a small amount for clinical use whilst meeting one of the following three conditions:
- Listed overseas but are not registered and listed in China
- Listed inside and outside China but are not produced by domestic enterprises
- Listed inside and outside China but domestic enterprises cannot resume production in a short period of time
Urgently needed drugs in a small amount for clinical use are defined as drugs that meet one of the following conditions:
- Drugs for the treatment of rare diseases.
- Drugs used to prevent and treat serious life-threatening diseases that do not yet have effective treatment or prevention.
- Drugs used for the prevention and treatment of serious life-threatening diseases and have obvious clinical advantages.
China “urgently needed drugs” temporary import – Application workflow
- Application: The medical institution is responsible for filing a temporary import application with the NMPA. For temporarily imported drugs for rare diseases, in principle, a medical institution belonging to the National Rare Disease Diagnosis and Treatment Collaboration Network will be the lead import agency to summarize the demands of all institutes nationally and apply to the NMPA.
- Review: After receiving the application from the medical institution, the NMPA shall review first, and then seek for the opinion of the National Health Commission (NHC).
- Approval: Within 3 working days after receiving the written feedback from the NHC, the NMPA will approve the import of the application that meets the requirements.
- Procurement: Medical institutions shall sign agreements with operating enterprises.
- Import: According to the consent letter, the medical institution applies to the drug regulatory administration department of the port for the “Custom Clearance Form for Imported Drugs”.
- Customs clearance: Medical institutions entrust units with import qualifications to do customs clearance.
- Delivery: The local authorized economic operator will be in charge of drug delivery.
- Others: For temporarily imported drugs that belong to narcotic drugs and psychotropic substances, the medical institutions can entrust units with import qualifications to apply to the NMPA for import permits for such drugs before the start of step 1) or step 4).
Management of drug use
Medical institutions that use temporarily imported drugs should do the following in accordance with the Regulations on the Administration of Pharmaceutical Affairs in Medical Institutions:
- Formulate clinical technical specifications, establish a special management system, and strictly regulate the medication behavior of physicians.
- Monitor and record clinical diagnosis and treatment records, safety efficacy information data.
- Formulate complete safety precautions and risk monitoring and disposal plans.
- Temporarily imported drugs should be reasonably stored in accordance with regulations.
- Temporarily imported drugs should be assessed on an annual basis and reported to the provincial health authorities.
- Select operating enterprises in accordance with regulations to carry out procurement, import and delivery of temporarily imported drugs and other related work.
Rights and responsibilities of interested parties
Medical institutions and local authorized economic operators bear the risk liability for the temporarily imported drugs. Medical institutions shall sign agreements with local authorized economic operators, who in turn shall sign agreements with overseas production enterprises to clarify the responsibilities of both parties and ensure the quality of drugs.
Overseas Marketing Authorization Holders (MAH) can check the lists of urgently needed drugs issued by the NMPA and then contact the Chinese medical institutions to confirm the needs. The NMPA has issued 3 lists of urgently needed drugs – see below for details:
- The first batch of clinically urgently needed overseas new drugs list
- The second batch of clinically urgently needed overseas new drugs list
- The third batch of clinically urgently needed overseas new drugs list
If you would like further information on how to register drugs or conduct clinical trials in China, please contact Cisema.