According to the notice issued by the State Drug Administration, in order to speed up the process of new drug import registration and meet the public demand for drug use, in accordance with the relevant requirements of the opinions on deepening the reform of the review and approval system and encouraging the innovation of pharmaceutical and medical devices issued by the general Office of the CPC Central Committee and the general office of the State Council, on April 28, 2018, the State Drug Administration was able to approve nine price people for cervical cancer prevention HPV vaccine (hereinafter referred to as HPV vaccine) is on the market.
After receiving the application for import registration of nine price HPV vaccine, SFDA will include it in the priority review procedure, communicate with enterprises on the overseas clinical data and post marketing safety monitoring of products for many times, and accept the overseas clinical trial data conditionally based on the previous four price HPV vaccine approval data, bridge with the overseas clinical data, and approve conditionally in the shortest time Import registration of the product. At the same time, the State Food and drug administration requires enterprises to formulate risk management and control plans and carry out post IPO research as required.
HPV vaccine is the first vaccine in the world to include cancer as an indication. The nine valent HPV vaccine approved in China consists of six, eleven, sixteen, eighteen, thirty-one, thirty-three, forty-five, fifty-two and fifty-eight HPV capsid proteins which are highly purified and mixed. The vaccine is suitable for 16 to 26 year old women and is used to prevent cervical cancer, vulvar cancer, vaginal cancer, anal cancer, genital warts, persistent infection, precancerous or atypical lesions caused by HPV. If there is hypersensitivity reaction on the active ingredient or any auxiliary ingredient of the approved product or the tetravalent HPV vaccine, it is forbidden; if there is hypersensitivity reaction symptom after the injection of the approved product or the tetravalent HPV vaccine, it shall not be vaccinated again.
So far, all kinds of HPV vaccines that have been listed and used in the world are available in China, which can better meet the different needs of the public for vaccination and provide new and effective means for the prevention of cervical cancer.