China will ease and speed up approval of drugs and medical devices as part of efforts to deepen healthcare reform, according to a new guideline released by the central authorities.[Special Coverage]
China will accept clinical trial data gathered overseas for applications to register drugs and medical devices, on condition that they are collected in multiple centers and meet Chinese requirements.
The guideline, jointly released by the general offices of the Central Committee of the Communist Party of China and the State Council, also calls for accelerating the review and approval process for urgently needed drugs and medical equipment.
Those items in early- or middle-stage clinical trials are permitted to enter the market with conditions attached, so as to provide treatment for severe life-threatening diseases that lack effective medication.
In the meantime, the guideline encourages innovation in the medical sector.
"Lack of intellectual property rights protection impedes the drug innovation process," said Wu Zhen, deputy director of China Food and Drug Administration. "The guideline offers measures to stimulate innovation."
The drug review and approval process will be linked with the patent process, so that infringement disputes can be addressed before the drugs hit the market.
Pilot compensation projects will be carried out, and patent holders will receive compensation if their drugs are delayed in going public because of clinical trials and the review and approval process.
Measures including setting up a catalog of marketed drugs and improving the protection of drug trial data will also be introduced, said the guideline.
From 2011 to 2015, 323 "innovative" drugs in China were approved for clinical research, and 139 new chemical generic drugs entered the market.
The guideline also bans medical representatives from selling drugs, and clarifies their responsibilities as promoting drugs in academic settings, introducing pharmaceutical knowledge to medical personnel and collecting suggestions during clinical use.
China started its latest round of healthcare reform in 2009, aiming to provide patient-oriented healthcare services.
As of September, all public hospitals in China had joined the comprehensive reform program to end the 60-year-old practice of drug price markups, helping to rationalize medical care costs.
As the reform proceeds, the share of drug sales in total revenues for hospitals dropped from 46.3 percent in 2010 to 38.1 percent in 2016.
In addition, China aims to build a basic medical services network covering both urban and rural areas, and completed a national reimbursement network for inpatient services in September.
The network allows any patient who is enrolled in China's public medical insurance systems to be reimbursed for inpatient expenses, no matter where they are treated.
Before these efforts, inpatients had to return to the locality where they were enrolled in public medical insurance in order to receive the reimbursement if they were treated at hospitals elsewhere.
Currently, 1.34 billion Chinese people are enrolled in various public medical insurance systems, accounting for up to 98.8 percent of the population.
