Temporary import of clinically urgent drugs to seek advice

2022-04-25 0 By

The National Health Commission (NHC) and the State Food and Drug Administration (SFDA) recently drafted and released a work plan for the temporary import of clinically urgent drugs (draft).The draft proposes to strengthen organizational guarantee and supervision, standardize and efficiently carry out temporary import of clinically urgent drugs, and the work plan applies to a small number of clinically urgent drugs that have been listed abroad and are not registered and listed in China, are not produced by enterprises or cannot be resumed in a short period of time.According to the draft, a small number of clinically urgent drugs are those that meet one of the following conditions: drugs for rare diseases;Medicines for the prevention and treatment of serious life-threatening diseases for which there is no effective treatment or prevention;Drugs with obvious clinical advantages for the prevention and treatment of serious life-threatening diseases.Medical institutions shall apply for temporary import to sFDA or provincial (regional or municipal) people’s governments authorized by The State Council and provide materials as required.After receiving an application from a medical institution, the SFDA may solicit opinions from the NHC on whether the medical institution applying has the ability to use and manage the drug, whether the drug is clinically urgent and whether the drug demand is reasonable, etc.Medical institutions using temporary imported drugs should, in accordance with the Provisions on Pharmaceutical Administration in Medical Institutions, focus on the formulation of clinical technical specifications, the formulation of perfect safety prevention measures and risk monitoring and disposal plans, annual evaluation of temporary imported drugs and report to provincial health authorities.According to the draft, medical institutions and distributors shall bear the risk responsibility for temporarily importing drugs in accordance with the law.The medical institution shall sign an agreement with the distributing enterprise, and the distributing enterprise shall sign an agreement with the overseas manufacturing enterprise to clarify the responsibilities of both parties and ensure the quality of the drug.Before taking medicine, the doctor should clearly explain the condition, the risk of taking medicine and other matters that need to be informed to the patient, and obtain informed consent in writing;If it is impossible or inappropriate to explain to the patient, it shall explain to the patient’s near relatives and obtain their informed consent in writing.It is also understood that, in order to meet the needs of clinical use of chlorobazine, the Work Plan for Temporary Import of chlorobazine (draft for comments) has also been published. Peking Union Medical College Hospital is planning to lead the import of chlorobazine, while Peking Union Medical College Hospital, Tianjin Children’s Hospital, the First Hospital of Jilin University and many other hospitals are planning to use chlorobazine.Statement: The copyright of this article belongs to the original author, if there is a source error or infringement of your legitimate rights and interests, you can contact us through email, we will deal with it in a timely manner.Email address: jpbl@jp.jiupainews.com