From Yan Jiangying, Deputy Director of China Drug Administration:
The Implementation Plan puts forward that the specific policy of imported drugs and medical devices urgently needed in clinic shall be expanded, and what are the benefits to patients in the Pilot Zone?
First of all, the special policy on imported drugs and medical devices urgently needed in clinic of the State Council is fully implemented. In other words, the State Council gives the privilege in drugs and medical devices to Hainan. Especially in medical devices, the State Council issued the Decision on Suspension of the ‘Regulation on the Supervision and Administration of Medical Devices’ in Hainan Boao Lecheng International Medical Tourism Pilot Zone last April, which suspended the implementation of paragraph 2 of Article 11 of the Regulation on the Supervision and Administration of Medical Devices. Therefore, the People’s Government of Hainan Province is responsible for the import approval of medical devices urgently needed in clinic of medical institutions in the pilot zone and without same kind of products registered in our country, and they shall be used in designated medical institutions. Last December, the State Council issued the Decision on Temporary Adjustment of the ‘Regulations for the Implementation of the Drug Administration Law of the People’s Republic of China’ in Hainan Boao Lecheng International Medical Tourism Pilot Zone, which specifies that the People’s Government of Hainan Province is responsible for the application approval of importing small amount of drugs urgently needed in clinic of medical institutions in Hainan pilot zone. These two Decisions bring Hainan a great opportunity. In order to implement decisions of the State Council, the National Medical Products Administration and the People’s Government of Hainan Province formulated the temporary provisions of these two decisions, which define the specific requirements for implementing drugs and medical devices urgently needed in clinic and their safety uses. That is to say, we shall work together to ensure the safety uses of drugs and medical devices in the Pilot Zone. As of now, a total of 4 varieties and 5 batches of drugs urgently needed in clinic have been approved for import in Hainan Province. A total of 17 batches and 26 varieties of medical devices urgently needed in clinic, as well as 271 products have been approved.
Second, the pilot of application of clinical real-world data is implemented. The application of clinical real-world data, different from new methodology of traditional clinical trial, is a research hotspot in the medicine field across the world. Now, National Medical Products Administration and Hainan specially establish a working group, draft a series of documents, including the Implementation Plan for Trial Application of Clinical Real-World Data at the Hainan Boao Lecheng International Medical Tourism Pilot Zone, and work out guidance documents related to the collection and analysis of clinical use data for urgent clinical imported drugs and medical devices at the Pilot Zone. The application of clinical real-world data can lower the economic and time costs brought by clinical trial, and is conducive to accelerating the use of global innovative drugs and medical devices in China. The trial in Hainan is also good for further promoting the application of national clinical real-world data.
Third, the trial of medical device registrant system and drug marketing license holder system in Hainan is supported. In August 2019, National Medical Products Administration expanded the trial scope to 21 provinces (regions and municipalities), including Hainan, based on the original trial. The promotion of medical device registrant system in Hainan will speed up the marketing of innovative medical devices and facilitate the rapid development of medical device industry in Hainan. At the same time, a new revision of the Drug Administration Law, adopted by the National People’s Congress, will be officially implemented on December 1, and it establishes special provisions for the drug marketing license holder system. National Medical Products Administration and Hainan will take full advantage of the successful experience of previous trial, and implement the drug marketing license holder system in Hainan.
Next, the Implementation Plan issued today will be put into practice from six aspects: 1. The approval of imported medical devices is accelerated at the Pilot Zone, and the application scope of pilot policy for a small quantity of urgent clinical imported drugs and medical devices is expanded to medical institutions that reach standards at the Pilot Zone. 2. The application of clinical real-world data is studied. The satisfactory clinical use data of a small quantity of urgent clinical imported drugs and medical devices at the Pilot Zone may be used for the application for registration of imported drugs and medical devices. 3. Drug marketing license holder system and medical device registrant system are implemented. 4. Top medical institutions in China are supported to establish a clinical trial institution at the Pilot Zone, and the clinical trial consistent with the ethical norm is carried out according to the laws and rules. 5. A review sub-center of national imported drugs and medical devices is established at the Pilot Zone. 6. The entrusted TCM formulation of medical institutions and TCM formulation made by traditional process are filed and managed, at the same time, the formulation reaching the national provisions in domestic medical institutions is allowed to be dispensed and used at the Pilot Zone. Such measures will further push forward the high-standard and high-quality development at the Pilot Zone.
Next, National Medical Products Administration will further put into practice the relevant standards of the Implementation Plan together with the concerned departments of Hainan, strengthen the guidance, take active actions for services, and implement detailed policies about measures.
The Implementation Plan puts forward that the specific policy of imported drugs and medical devices urgently needed in clinic shall be expanded, and what are the benefits to patients in the Pilot Zone?
First of all, the special policy on imported drugs and medical devices urgently needed in clinic of the State Council is fully implemented. In other words, the State Council gives the privilege in drugs and medical devices to Hainan. Especially in medical devices, the State Council issued the Decision on Suspension of the ‘Regulation on the Supervision and Administration of Medical Devices’ in Hainan Boao Lecheng International Medical Tourism Pilot Zone last April, which suspended the implementation of paragraph 2 of Article 11 of the Regulation on the Supervision and Administration of Medical Devices. Therefore, the People’s Government of Hainan Province is responsible for the import approval of medical devices urgently needed in clinic of medical institutions in the pilot zone and without same kind of products registered in our country, and they shall be used in designated medical institutions. Last December, the State Council issued the Decision on Temporary Adjustment of the ‘Regulations for the Implementation of the Drug Administration Law of the People’s Republic of China’ in Hainan Boao Lecheng International Medical Tourism Pilot Zone, which specifies that the People’s Government of Hainan Province is responsible for the application approval of importing small amount of drugs urgently needed in clinic of medical institutions in Hainan pilot zone. These two Decisions bring Hainan a great opportunity. In order to implement decisions of the State Council, the National Medical Products Administration and the People’s Government of Hainan Province formulated the temporary provisions of these two decisions, which define the specific requirements for implementing drugs and medical devices urgently needed in clinic and their safety uses. That is to say, we shall work together to ensure the safety uses of drugs and medical devices in the Pilot Zone. As of now, a total of 4 varieties and 5 batches of drugs urgently needed in clinic have been approved for import in Hainan Province. A total of 17 batches and 26 varieties of medical devices urgently needed in clinic, as well as 271 products have been approved.
Second, the pilot of application of clinical real-world data is implemented. The application of clinical real-world data, different from new methodology of traditional clinical trial, is a research hotspot in the medicine field across the world. Now, National Medical Products Administration and Hainan specially establish a working group, draft a series of documents, including the Implementation Plan for Trial Application of Clinical Real-World Data at the Hainan Boao Lecheng International Medical Tourism Pilot Zone, and work out guidance documents related to the collection and analysis of clinical use data for urgent clinical imported drugs and medical devices at the Pilot Zone. The application of clinical real-world data can lower the economic and time costs brought by clinical trial, and is conducive to accelerating the use of global innovative drugs and medical devices in China. The trial in Hainan is also good for further promoting the application of national clinical real-world data.
Third, the trial of medical device registrant system and drug marketing license holder system in Hainan is supported. In August 2019, National Medical Products Administration expanded the trial scope to 21 provinces (regions and municipalities), including Hainan, based on the original trial. The promotion of medical device registrant system in Hainan will speed up the marketing of innovative medical devices and facilitate the rapid development of medical device industry in Hainan. At the same time, a new revision of the Drug Administration Law, adopted by the National People’s Congress, will be officially implemented on December 1, and it establishes special provisions for the drug marketing license holder system. National Medical Products Administration and Hainan will take full advantage of the successful experience of previous trial, and implement the drug marketing license holder system in Hainan.
Next, the Implementation Plan issued today will be put into practice from six aspects: 1. The approval of imported medical devices is accelerated at the Pilot Zone, and the application scope of pilot policy for a small quantity of urgent clinical imported drugs and medical devices is expanded to medical institutions that reach standards at the Pilot Zone. 2. The application of clinical real-world data is studied. The satisfactory clinical use data of a small quantity of urgent clinical imported drugs and medical devices at the Pilot Zone may be used for the application for registration of imported drugs and medical devices. 3. Drug marketing license holder system and medical device registrant system are implemented. 4. Top medical institutions in China are supported to establish a clinical trial institution at the Pilot Zone, and the clinical trial consistent with the ethical norm is carried out according to the laws and rules. 5. A review sub-center of national imported drugs and medical devices is established at the Pilot Zone. 6. The entrusted TCM formulation of medical institutions and TCM formulation made by traditional process are filed and managed, at the same time, the formulation reaching the national provisions in domestic medical institutions is allowed to be dispensed and used at the Pilot Zone. Such measures will further push forward the high-standard and high-quality development at the Pilot Zone.
Next, National Medical Products Administration will further put into practice the relevant standards of the Implementation Plan together with the concerned departments of Hainan, strengthen the guidance, take active actions for services, and implement detailed policies about measures.