Recently, the 21st Century Business Herald learned that Chen Baohua, deputy to the 13th National People’s Congress and President of Zhe Jiang Hua Hai Pharmaceuticalco.Ltd(600521) ( Zhe Jiang Hua Hai Pharmaceuticalco.Ltd(600521) . SH), is preparing to submit two motions and four suggestions this time.
Focusing on the pharmaceutical industry, Chen Baohua paid attention to the problem that China’s class 1 innovative drugs and class 2 improved new drugs cannot be imitated, and put forward “suggestions on improving China’s new drug imitation policy”.
According to the current requirements for registration classification and application data of chemical drugs, “category 1” of China National Chemical Engineering Co.Ltd(601117) drugs refers to “innovative drugs that are not listed at home and abroad, and drugs that contain new compounds with clear structure, pharmacological effects and clinical value”; “Category 2” refers to “improved new drugs that are not listed at home and abroad, which refer to drugs with obvious clinical advantages by optimizing their structure, dosage form, prescription process, administration route and indications on the basis of known active ingredients”.
Chen Baohua told 21st Century Business Herald, As the demand for new drugs and generic drugs in China is becoming more and more urgent, there is an urgent need to improve the safety of new drugs in China. However, there is an urgent need for new drugs and generic drugs in China. 2 It can be imitated, and there is a phenomenon that a company monopolizes the market for a long time after listing (even if the patent protection period of new drugs has long expired), forming a monopoly price sales. This is not only contrary to the purpose of medical reform, such as improving the accessibility of drugs, reducing the drug burden of the people and the expenditure of national medical insurance expenses, but also inconsistent with the principle of drug examination system reform, which encourages both innovation and imitation. ”
According to the requirements for registration, classification and application materials of chemical drugs, “reference preparation refers to the reference drug used in the development of generic drugs evaluated and confirmed by the national drug regulatory department. The selection and publication of reference preparation shall be carried out in accordance with the relevant provisions of the national drug regulatory department.”
From the list of all batches of reference preparations published so far, there are no Chinese new drugs approved for marketing.
“no matter in terms of policy or in practice, Chinese new drugs have no status of reference preparations. Without reference preparations, it is impossible to study the consistency of quality and efficacy, and pharmaceutical enterprises are unable to copy Chinese new drugs. This is the root cause of the impossibility of copying Chinese New drugs.” Chen Baohua pointed out to the 21st Century Business Herald reporter
in this regard, Chen Baohua suggested that we should speed up the revision and improvement of the current relevant policies, endow China with the status of reference preparation of new drugs, create preconditions for the imitation of new drugs in China, and encourage the listing of generic drugs. First, China’s class 1 innovative drugs that have been approved for marketing and China’s class 2 improved drugs that have been approved for marketing and have clinical value / advantages, safety and effectiveness are directly given the status of reference preparations. Second, the national drug regulatory department will organize a comprehensive review and evaluation of China’s class 2 improved new drugs that have been approved for listing but whose clinical advantages are not clear
