Objective To carry out an on-site inspection to promote the optimal allocation of inspection resources through the introduction of risk management theory in the process of inspection because inspection can prevent drug quality deterioration and ensure drug safety and efficacy. Methods The application of Food and Drug Administration (FDA) risk management plan in pre-registration and daily supervision was analyzed to study the construction of inspection model for production site based on risk management procedures. Results and Conclusion In order to improve regulatory efficiency, China can establish a risk-based drug inspection system from FDA risk management plan.
Objective To investigate and analyze the residents’ cognition and use of traditional Chinese medicine (TCM) and put forward corresponding countermeasures for its existing problems. Methods A questionnaire survey was conducted to investigate the cognition and trust of TCM from 380 residents in Liaoning Province. Then, the differences of residents’ way of purchasing TCM and gaining the knowledge of TCM. Finally, Polygonum multiflorum was taken as an example to analyze the problems in residents’ cognition and use of Chinese medicinal materials, Chinese traditional decoction pieces, and Chinese patent medicine. Results and Conclusion A total of 402 questionnaires were collected, and 380 were valid. The effective rate was 94.53%. Residents’ understanding of the top three TCM processing techniques were simmering (58.95%), baking (56.84%), and parching (45.00%). The top three best-known TCM for them were chrysanthemum (72.63%), tangerine peel (63.16%), and hawthorn (62.11%). The main factors influencing residents’ willingness to purchase TCM were doctors’ advice (52.63%), and experts or experienced people’s suggestion (54.21%). The top three ways of residents’ gaining TCM knowledge were: TCM knowledge lecture (64.21%), health care knowledge (55.79%), and personal experience of Chinese medicine such as acupuncture and cupping (54.21%). However, due to the lack of professional knowledge of TCM, insufficient supervision and inconsistent standards, residents frequently took TCM by mistake. Residents have a high recognition of TCM, so its future development is optimistic. However, some residents’ insufficient knowledge of TCM often leads to the misapplication of the medicine. Therefore, to improve residents’ cognition of
TCM, it is not only to actively publicize the professional knowledge of TCM, but also to improve the professional skills of practitioners, and the supervision standards and intensity of TCM market, so as to make residents feel at ease to buy safe and high-quality TCM products.
Objective To establish an economic value added (EVA) performance evaluation system to maintain the competitiveness of pharmaceutical company A under the environment of fierce competition in the pharmaceutical industry. Methods An EVA performance evaluation model was established by adjusting the items of EVA performance evaluation index, such as after-tax profits, total invested capital and weighted average cost of capital rate. Results and Conclusion EVA values of pharmaceutical company A from 2014 to 2018 were calculated and compared with the traditional performance evaluation method, it was found that EVA performance evaluation model reflected the real performance of pharmaceutical company A. Therefore, pharmaceutical company A is doing well, but its growth rate is unstable.
Objective To analyze the application of real-world evidence (RWE) in the field of medicine in European Union, and provide suggestions for RWE supporting the review and approval of new drugs in China. Methods The European Medicines Agency (EMA) and other databases were used to search relevant documents for analyzing the European Union’s new drug review and approval process with the support of RWE. Results and Conclusion The European Union carrying out new drug review and approval with the support of RWE has just begun. The decision-making process includes three stages such as new drug research and development, review, and approval. However, there are some challenges in data quality, research methods, evidence sufficiency, and research process of RWE supporting the European Union in reviewing and approving new drugs. At present, RWE can accurately grasp the clinical effects of drugs and improve the safety and effectiveness in the process of assisting the review and approval of new drugs. At the same time, RWE also can promote the development and application of Traditional Chinese Medicine (TCM) and help find out the potential value of TCM such as new indications.
Objective To analyze the causes of drug shortages in China and put forward some countermeasures and suggestions accordingly. Methods Based on the relevant data of 14 provinces that issued the lists of drug shortages from 2018 to 2020, 377 kinds of drugs were sorted out first, and then the features of shortage were analyzed descriptively. Finally, the degree and causes of shortage were studied based on field investigation and literature summary. Results and Conclusion Among the drugs in short supply across the country, 69.2% of them were listed in the National Medical Insurance Catalogue, 37.1% were essential drugs and 26.5% were low-price drugs. They were used for different diseases, and most were for treating nervous system and blood system. There were many reasons for drug shortages. For instance, any problems in supply chain (production, circulation, use) could lead to drug shortages, of which the production accounted for the largest proportion. This paper puts forward targeted measures to solve drug shortages from the aspects of unwillingness and inability of manufacturing enterprises in their production.
