Analysis and Suggestions on Status Quo of Commissioned Production under Medical Device Marketing Authorization Holder System in China / 中国医疗器械杂志

OBJECTIVE@#Sort out and analyze the current status and existing problems of the pilot work of the medical device marketing authorization holder system to provide reference opinions for the full implementation of the medical device marketing authorization holder system.@*METHODS@#Use literature analysis, comparative analysis and field research to comprehensively analyze the status, advantages and risks of commissioned production under the medical device marketing authorization holder system.@*RESULTS@#The commissioned production under the medical device marketing authorization holder system brings dividends and also brings risks.@*CONCLUSIONS@#We should consider improving the medical device marketing authorization holder system from marketing authorization holder, the entrusted manufacturer, and the regulatory authority, and strengthen the quality supervision of the entrusted production of products.

Study on Technical Risks and Primary Responsibility of Medical Artificial Intelligence Diagnosis Products under Strategy of "Healthy China" / 中国医疗器械杂志

OBJECTIVE@#It provides reference for accurate and efficient supervision of medical artificial intelligence industry.@*METHODS@#By summarizing the main responsibility dilemma of medical artificial intelligence diagnosis products, sorting out relevant researches at home and abroad, the primary responsibility system of medical artificial intelligence diagnosis products is constructed.@*RESULTS@#A medical artificial intelligence diagnosis products primary responsibility system with the marketing authorization holder as the "first responsible person" is established, and three safeguard measures are proposed, namely, algorithm transparency and interpretability, classification supervision mode and social co-governance supervision mode.@*CONCLUSIONS@#The medical artificial intelligence diagnosis products primary responsibility system is helpful to implement the primary responsibility, to build "responsible and beneficial" artificial intelligence, and to realize "self-discipline", "good governance" and "in good order".

Analysis of Risk Factors of MAH Pharmacovigilance Outsourcing / 中国药房

OBJECTIVE：To analyze th e risk factors of marketing authorization holder （MAH）pharmacovigilance outsourcing and propose risk management and control strategies ， and to provide reference for MAH to successfully implement pharmacovigilance outsourcing and regulatory authorities to formulate corresponding regulatory strategies. METHODS ：Based on the principal-agent theory and brainstorming method ，the risk factors were preliminarily determined ，and a questionnaire was designed. The questionnaire survey was carried out among pharmacovigilance staff of 200 MAH in Guangdong province by random sampling. The factor analysis method was used to statistically analyze the questionnaire data ，and the comprehensive risk factors and their respective factor scores were summarized. RESULTS & CONCLUSIONS ：A total of 200 questionnaires were distributed ， and 154 valid questionnaires were returned ，with effective recovery rate of 77.00％. The results of factor analysis method showed that there were 4 comprehensive risk factors involved in MAH pharmacovigilance outsourcing activities ，which were service providers and outsourcing management factor （3.792 score），MAH factor （3.766 score），regulations factor （3.626 score）and market factor （3.610 score）from high to low. In view of the above factors ，it is suggested that MAH should focus on improving outsourcing contract ，establishing information communication mechanism with service providers ，strengthening auditing and management，strengthening pharmacovigilance ability and personnel building ，defining appropriate pharmacovigilance outsourcing business contents ， and fully doing pre-service investigation of service providers ， when MAH conducts outsourcing of pharmacovigilance. It is suggested that relevant departments should formulate pharmacovigilance entrusted quality management specifications or guidelines as soon as possible and strengthen the supervision of service providers. It is suggested to try to establish a pharmacovigilance outsourcing industry associa tion， andstandardize the industry behavior by giving full play to the influence of the association ，so as to avoid the outsourcing risk.

Preliminary Review of Relationship between Medical Device Evaluation and Quality Management System in Premarket Approval / 中国医疗器械杂志

This paper analyzed the current reform of review and approval mechanism for medical devices and discussed the method for technical review process extending to product quality controllable direction and found the measures and suggestions to strengthen technical review for quality management system with the help with complementary relationship between the technical review and the quality management system assessment of the pre-market registration. Nowadays, because of the demand of eRPS， MAH and the amendment of regulation, the integration of technical review and quality management system is more important, necessary and scientific. Scientific and systematic evaluation should be carried out to strengthen the pre-market approval of medical devices and ensure the safety and effectiveness of medical products.

Analysis of Influential Factors for the Construction of ADR Damage Relief System under MAH System ：Based on the Perspec- tive of Pharmaceutical Manufacturers in Shaanxi Province / 中国药房

OBJECTIVE： To provide reference for constructing ADR damage relief system in China. METHODS： Questionnaire survey was conducted among 217 pharmaceutical manufacturers in Shaanxi province by census method. Fisher’s exact test， Pearson χ2 test and multivariate Logistic regression analysis were used to analyze the factors effecting construction of ADR damage relief systerm unter marketing authorization holder （MAH） system， and the interaction among various factors. RESULTS： A total of 217 drug manufacturers were investigated in this study （217 questionnaires were sent out）. 209 questionnaires were collected and 204 valid questionnaires were screened out with recovery rate of 94.01％. Totally 9 independent influential factors screened by Fisher’s exact test and Pearson χ2 test had a significant impact on the attitude of building ADR damage relief system under MAH system， i.e. the last year’s earnings of enterprises， the proportion of pharmaceutical technicians， whether to set up R&D departments， whether to obtain new drugs/generic drugs in recent 3 years， whether to actively carry out post-marketing safety evaluation of drugs， whether ADR commissioners are familiar with ADR-related policies in MAH system， cognition about whether MAH system promotes the development of pharmaceutical industry， the development direction of enterprises after the full implementation of MAH， cognition about the lack of legal basis for ADR damage relief （P＜0.05）. Multivariate Logistic regression analysis showed that whether the ADR specialist was familiar with the ADR-related policies in MAH system was the main influential factor for constructing ADR damage relief system under the MAH system （P＝0.044）. It was positively correlated with the attitude of approving the construction of ADR damage relief system under MAH system （B＝1.697）. CONCLUSIONS： The pharmaceutical manufacturers， in which ADR specialists who are familiar with the ADR-related policies in the MAH system， are more inclined to agree to constructing ADR damage relief system under  MAH system.

Recommendation on Pilot Work and Related Policies of Medicine Marketing Authorization Holder System in China / 中国药房

OBJECTIVE:To investigate and perfect the pilot work of medicine marketing authorization holder system in China. METHODS:The problems of medicine marketing authorization system in China and the features of medicine marketing licensing system in USA and EU were analyzed. The legal authority and content of pilot medicine marketing authorization holder system in China were summarized so as to propose related policy recommendation. RESULTS & CONCLUSIONS:There are many problems in the medicine authorization system in China which is the combination of“production license”and“marketing license”,for exam-ple,the obsolete definition of“new drugs”,the serious waste of drug resources,the insufficient research and development of new drugs. The“production license”and“marketing license”are separated in the USA and EU. There are many new drugs,high capaci-ty utilization and perfect system of drug safety,quality control and risk management. In order to ensure the effective implementa-tion of the pilot work,it is suggested to enhance and improve the quality authorization management,the pharmacovigilance system and drug injury relief related to drug safety management.

Research on drug marketing authorization system design based on revision of the drug administration law / 中国药学杂志

OBJECTIVE: To put forward some suggestions on drug marketing authorization system design for the revision of Drug Administration Law. METHODS: Compared the difference for drug marketing authorization system design of China, the US and EU, analyzed the advantage of the marketing authorization system of the US and EU; RESULTS AND CONCLUSION: Presented 4 key elements for drug marketing authorization system, put forward that to allow applicant and applicant holder change, remove the binding between marketing authorization and manufacturer, strengthen responsibilities and obligations for applicant and applicant holder's safety and efficiency assurance during the entire life cycle of the drug, and for manufacturers and distributors' quality assurance and implementing supply chain traceability.