How qualified is the nine-valent cervical cancer vaccine to be approved for marketing?

In order to speed up the process of new drug import registration and meet the public demand for drugs, according to the relevant requirements of Opinions on Deepening the Reform of Review and Approval System and Encouraging the Innovation of Medical Devices issued by the General Offices of the General Office of the Central Committee of the CPC and the State Council, from 2065438 to April 28, 2008, the State Pharmaceutical Products Supervision and Administration conditionally approved the listing of nine-valent human papillomavirus vaccine (hereinafter referred to as HPV vaccine) for preventing cervical cancer.

After receiving the application for import registration of nine-valent HPV vaccine, the State Administration of Pharmaceutical Products included it in the priority review procedure, and communicated with enterprises for many times on the overseas clinical data and post-marketing safety monitoring of the product. On the basis of the pre-approval data of tetravalent HPV vaccine, it is conditional to accept overseas clinical trial data and bridge it with overseas clinical data, and conditionally approve the import registration of the product in the shortest time. At the same time, the State Administration of Pharmaceutical Products requires enterprises to formulate risk control plans and conduct post-marketing research as required.

HPV vaccine is the first vaccine with cancer as an indication in the world. The nine-valent HPV vaccine approved in China is a virus-like particle composed of major capsid proteins of human papillomavirus types 6, 1 1 6, 18, 3 1, 33, 45, 52 and 58. The vaccine is suitable for women aged 16 to 26, and can be used to prevent cervical cancer, vulvar cancer, vaginal cancer, anal cancer's disease, genital warts, persistent infection, precancerous lesions or atypical lesions caused by human papillomavirus. Those who are allergic to the active ingredients or any auxiliary ingredients of approved products or tetravalent HPV vaccines are prohibited; Those who have allergic symptoms after injecting approved products or tetravalent HPV vaccine should not be vaccinated again.

Up to now, there are varieties of HPV vaccines that have been marketed and used in the world in China, which can better meet the different needs of the public for vaccination and provide a new and effective means for the prevention of cervical cancer.

Source:? the State Drug Administration (SDA)