Boao first try the first area, the import of new drugs is expected to increase speed!

Medicine Network April 26 News Boao first try the first area, import new drugs is expected to speed up again!

Yesterday, the State Food and Drug Administration issued a document stating that the medical institutions in the pioneer district are studying the issue of urgently importing a small amount of drugs for clinical use, and simplifies the procedure.

Recently, the State Drug Administration has formulated the urgent need for the import of clinically advanced international medical tourism predecessor in Hainan Boao Music City. medical instruments "Interim Regulations on Management", which clearly defines the scope, conditions of use, procedures and related responsibilities for clinically urgently approved medical device imports.

It is reported that the pioneer district in Bo'ao is similar to the new drug special zone. Approved on the market for overseas approvals, applications for registration of pharmaceutical imports 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 because of clinical need, the relevant laws may be used. Regulation The request shall be filed with the drug regulatory department of the State Council. After approval, the imported drug shall be used within the designated medical institution for specific medical purposes.

The Food and Drug Administration issued a document that the designated medical institutions in the pioneer district must urgently use imported drugs for clinical purposes. Medical devices can provide clinical data for the registration of related products in China while meeting the diagnosis and treatment of special populations.

The State Council of the Food and Drug Administration unanimously believes that the first trial in the pioneer area will help further accumulate experience. For deepening implementation of the China Affairs Office, the State Council’s “Opinions on Deepening the Reform, Review, Approval System, and Encouraging the Innovation of Drugs and Medical Devices” (Hall [2017] No. 42) The document is of great significance.

China’s first socially-run platform for business profit from March 31 hospital - The Boao Super Hospital was officially opened, and China News Agency 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 to achieve 'synchronized use of Chinese and foreign medicines' within the music city's predecessor.

The time to market of Chinese and foreign innovative drugs has a long history. Usually in 6-8 years, the time difference has brought great difficulties to 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 Bureau of Food Administration issued a document to import the first district of Boao. drug To simplify the process, Zhang Maoxin, director of the State Administration of Market Supervision and Administration, has shortened the time for review and approval of drug listings to two to three years. It can be seen that the new drug market has entered a phase of full acceleration.