Two important medical policy documents are issued

Two important documents were issued: On March 30, 2020, the official website of the State Administration for Market Supervision and Administration announced the 2020 new version of the "Drug Registration and Management Measures" and "Drug Production Supervision and Management Measures".

    The new version of "Administrative Measures for Drug Registration" was updated again after 13 years, and was officially implemented on July 1 this year. The approach emphasizes clinical value, encourages research and creation of new drugs, and actively promotes the development of generic drugs. The State Drug Administration continues to promote the reform of the review and approval system, optimize the review and approval procedures, improve the efficiency of review and approval, and establish a drug registration management system that is led by the review and supported by inspection, verification, monitoring, and evaluation.

  The reform directions of the new "Drug Registration Management Measures" and "Drug Production Supervision and Management Measures": encourage innovation, optimize and improve the efficiency of review and evaluation. These two new versions of the document basically benchmark the US FDA and open four channels to speed up the launch of new drugs. In order to encourage innovation and meet the urgently needed clinical drugs in China, applicants can apply for the application of breakthrough therapy drugs, conditional approval, priority review and approval, and special approval procedures. The breakthrough therapeutic drug program is positioned at the stage of drug clinical trial development; the conditional approval and priority review and approval process is positioned at the stage of drug market registration. The special approval process is aimed at public health emergencies and threats.

   We can take the example of the special approval process in the United States. Recently, the US FDA quickly approved the BGI gene test kit, which is based on the public health incident and the special approval process. If the normal process is followed, it will take about half a year or a year. When the epidemic is over, there will be a test kit, and the epidemic can't wait.

Simplify the clinical trial process and further shorten the review time. Emphasize the connection of drug registration acceptance, review, verification and inspection. The application for drug clinical trial shall be decided within 60 days from the acceptance date, and the bioequivalence trial shall be filed and implemented. The time limit for reviewing the application for marketing authorization of drugs is 200 days, including 130 days for priority review and approval, 70 days for clinically urgently needed drugs that have been marketed abroad for rare diseases; 200 days for individual declarations of generic drugs that have been marketed in China; 120 days. This policy shortens the approval time and accelerates the approval of new drugs and APIs. In 2015, listed companies applying for a new drug clinical trial may have to wait more than half a year or even years.

Fully implement the drug marketing license holder system. It is clarified that the holder is an enterprise or drug research institution that can bear corresponding responsibilities, and it is required to establish a drug quality assurance system to manage the full life cycle of the drug, carry out post-marketing research, and bear the responsibility for the safety, effectiveness and quality of the listed drug. The holder system encourages the outsourcing of new drug R & D services and benefits CRO and CMO companies.

Emphasizing the related evaluation, the status of raw materials, excipients, and pharmaceutical packaging materials has been significantly improved. The State Drug Administration has established a system for the related review and approval of chemical raw materials, auxiliary materials, and packaging materials and containers in direct contact with drugs. When examining and approving pharmaceutical preparations, the chemical raw materials, auxiliary materials, and packaging materials and containers that directly contact the drugs are subject to relevant review. Those who imitate the chemical raw materials used in drugs already marketed in China may apply for separate review and approval. This policy has significantly improved the status of companies such as APIs, excipients, and pharmaceutical packaging materials, focusing on the development of the new drug industry chain, APIs, and accessories.