Boao first try the first area, the import of new drugs is expected to increase speed!
Yesterday, the State Food and Drug Administration issued a document stating that the medical institutions in the pre-empty district are studying the issue of urgently importing a small amount of drugs for clinical use and will simplify the procedures.
简化Simplify the import of new drug programs in antecedent districts
Recently, the State Drug Administration has formulated the "Provisional Regulations for the Administration of Imported Medical Devices for Clinically Urgent Needs in the International Medical Tourism Pioneer District of Hainan Boao Music City", which clearly defines the scope, conditions of use, procedures for handling, and related responsibilities for clinical urgently needed medical devices.
It is reported that the pioneer district in Bo'ao is similar to the new drug special zone. Approved for listing abroad, and applications for registration of drug import that have not been approved for registration in China may apply for special approval in accordance with the requirements of the special approval management regulations for new drug registration.
For medical institutions that urgently need to import a small amount of drugs for clinical purposes, they may apply to the drug regulatory department of the State Council in accordance with the requirements of relevant laws and regulations. After approval, the imported drugs shall be used for specific medical purposes within the designated medical institutions.
The Food and Drug Administration issued a document that the designated medical institutions in the foreseeing district must urgently use imported drugs for clinical purposes. Medical devices can provide clinical data for the registration of related products in China while satisfying the diagnosis and treatment of special populations.
The State Council of the State Administration of Food and Drug Control unanimously believes that preemptive testing in the pioneer area will help further accumulate experience. For deepening the implementation of the China National Office, the State Council’s “Opinions on Deepening the Reform, Review, Approval System, and Encouraging the Innovation of Drugs and Medical Devices” (Room [2017] No. 42) The document is of great significance.
Zhang Mao: Time to market for new drugs shortened to 2-3 years
Since March 31st, China’s first profit-making platform for hospitals, the Boao Super Hospital, was officially opened. China News recently reported two heavy news reports:
First, after the reform of the State Council, the newly established State Drug Administration (SDA) will soon release the foreign medical equipment to be introduced in the predecessor area to the Hainan Provincial People's Government;
Second, the National Bureau (SDA) submitted a report to the Central Government in conjunction with the Hainan Provincial Government. The application was authorized by the Standing Committee of the National People's Congress to allow Hainan Province to break through the provisions of the "Drug Administration Law," and realize the 'simultaneous use of Chinese and foreign medicines' within the music city's predecessor.
The time to market for Chinese and foreign innovative drugs has a long history. Usually in 6-8 years, the time difference has caused great difficulties for drug accessibility and market competition for pharmaceutical companies. According to relevant statistics, only 30% of heavy drugs in European and American markets can Introduced into China.
Yesterday, Zhang Mao, director of the State Administration of Market Supervision, said in an exclusive interview with the People's Daily reporter that the phase-by-step time for review and approval of new drug listings will be shortened from 7-8 years to 2-3 years.
On the same day, the Food and Drug Administration issued a document to expedite the import of medicines in the first district of Boao. The director of the State Market Supervision Administration, Zhang Maoxin, reviewed and approved the time for approval of the drug and shortened it to 2-3 years. It can be seen that the new drug market has entered the phase of full speedup.
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