China News Service, Beijing, July 20 (Reporter Li Yanan) While the third batch of national organizations focused on the procurement of drugs to promote the transformation and upgrading of the pharmaceutical industry, ensuring the quality and safety of drugs has also received increasing attention from all walks of life. Experts here call attention to the full life cycle management of anti-tumor drugs.
Professor Xu Binghe, director of the National Drug (Antitumor Drug) Clinical Research Center and the Cancer Hospital of the Chinese Academy of Medical Sciences, said that in recent years, with the continuous improvement of the availability of oncology drugs and the acceleration of the launch of innovative drugs, cancer patients can use more More high-quality anti-tumor drugs. However, drug management issues are also becoming increasingly prominent, such as non-standardized medications, regional management differences, etc., and the urgent need to introduce principles and guidelines for the use of anti-tumor drugs, establish and improve the quality management system, and consolidate the efficacy and safety of drugs.
"The new coronary pneumonia epidemic gives us a deeper understanding of the concept of'people's health is supreme'." Yi Zhengyu, executive vice president and secretary general of the Shanghai Pharmaceutical Industry Association, pointed out that the newly revised drug management law last year clearly proposed the society The principle of co-governance adheres to the principles of risk management, overall control and social co-governance, establishes a scientific and strict supervision and management system, comprehensively improves the quality of medicines, and ensures the safety, effectiveness and accessibility of medicines. In the future, the association will continue to work with experts and scholars in the field of medicine to promote the continuous improvement of the quality of medicines by formulating high-quality differentiated group standards to meet the growing health needs of the people.
In order to better analyze the quality management of the entire life cycle of cancer drugs, Professor Chen Zhidong of the Sixth People's Hospital Affiliated to Shanghai Jiaotong University, Professor Huang Zhongyi, Honorary Director of the Department of Clinical Pharmacy and Clinical Pharmacology, Central Hospital of Jing'an District, Shanghai, and Zhang Jian, Cancer Hospital of Fudan University The professor and Professor Wang Zitao from the Department of Industrial Engineering of Tsinghua University introduced the difference between original research and generic drugs of narrow therapeutic index drugs (NTIDs), emphasizing careful selection of original research or generic NTIDs.
According to experts, NTIDs refer to drugs that have a small difference in dosage or blood concentration, which may lead to serious treatment failure and/or adverse drug reactions. Small differences in production technology and quality will directly cause safety problems or lack of efficacy. The relationship between drug safety and the quality of pharmaceuticals in pharmaceutical companies is even closer. Although NTIDs are special, there is still a lack of a complete list of countries, and the classification of drug varieties in various countries is not completely consistent. There is an urgent need for the drug supervision and management department to improve management and formulate regulations.
Consistency evaluation is used to ensure the consistency of the quality and efficacy of generic drugs and original drugs, but despite this, bioequivalent subjects cannot represent all clinical patients. In clinical practice, the phenomenon of unequal efficacy is very common. If the efficacy of the generic drug and the original research drug are different, it may cause the effect to increase or decrease, and produce other adverse reactions, which will affect the treatment of the disease.
Relevant departments in Shanghai have recently released the "General Technical Requirements for the Quality Evaluation and Standards of Narrow Therapeutic Index Drugs", which includes NTIDs quality management, quality evaluation, stability studies, and quality standard establishment; 14 drugs are listed in the " Narrow Therapeutic Index Drug List.
Experts emphasized that strict quality management of NTIDs should be carried out throughout the life cycle to ensure that the key quality attributes of the drug can be effectively maintained and passed through at all stages of the life cycle.
It is reported that the seminar "China Quality Miles" on the theme of "Oncology Drug Treatment Standards and Quality Control" was launched in July in Beijing, Shanghai, Guangzhou, Nanjing, Hangzhou and other 10 cities. Clinical and pharmacologists discuss the safety and quality standards of tumor drugs here. (Finish)