Development Of "Report On The Management And Monitoring Of Adverse Drug Reactions"

Adverse drug reaction reporting and monitoring in the early detection ofadverse drug reactions and adverse drug events, and to avoid duplication of injuryoccurrence and spread of events has played an important role, the China Food andDrug Administration (CFDA) attaches great importance to this work, One of themain content is to be included in the regulation of drug marketing, and continues tostrengthen the regulatory and monitoring system.1984"Drug Administration Law"stipulates that the monitoring of adverse reactions to drugs as an important partsupervision, monitoring of adverse reactions marked the beginning of the legalsystem. In1999the former State Drug Administration in conjunction with theMinistry of Health jointly issued the "Administrative Measures for Adverse DrugReaction Monitoring (Trial)" ending years of adverse drug reaction monitoringnowhere situation.2001revised "Drug Administration Law of the People’s Republicof China," Article71of the "national implementation adverse drug reaction reportingsystem". Since then embarked on a legal ADR monitoring system tracks;2004,CFDA in conjunction with the Ministry of Health jointly issued the "adverse drugreaction reporting and monitoring management approach"(hereinafter referred toas version04"Rules"), the level of legal normative documents promoted todepartment rules;2011the Ministry of Health issued a revised "adverse drugreaction reporting and monitoring management approach"(hereinafter referred to asversion11"Rules"), to further promote the launch of adverse drug reactionmonitoring of the work, for the protection of public administration build an effectivesecurity barrier. Promulgated the "Measures" version11for Adverse Drug ReactionMonitoring and drug safety regulation provides a good opportunity for development,but there are some problems in the implementation process; For example, medicalinstitutions reported enthusiasm is not high, reporting quality is not high, drugmanufacturers ineffective ADR monitoring work carried out, low public awarenessof ADR, the lack of knowledge on the ADR, the punishment is not enough; therefore the Topic hope through field research, learn foreign advanced methods and conceptsto explore a scientific and reasonable "adverse drug reaction reporting andmonitoring management approach" for better implementation and improvement ofChina’s "adverse drug reaction reporting and monitoring management approach"provide some suggestions and references.There are the subject of research methods used in comparative studies, researchstatus, drawing on studies and literature studies and other methods, the developmentof the "measures" were discussed our system. Which is a comparative study of twomajor versions of the "measures" to be in contrast to the structural frame, thecontents of each chapter, the status quo research involves manufacturing enterprisesin Henan Province, medical institutions and drug regulatory departments edition11"measures" the implementation, draw study of US, EU and ICH monitoring ofadverse drug reactions in terms of the laws and regulations are discussed, analyzedresearch literature from2009to2013for the monitoring of adverse reactionsbetween the contents of the domestic pharmaceutical literature.Comparative studies have shown that edition11"measures" by the version of04"measures" eight chapters chapters33to67, an increase of two chapters focus onmonitoring medicines and information management; edition11"measures" to furtherclarify the provincial level responsibilities of regulators and adverse drug reactionmonitoring bodies, standardized reporting procedures and requirements, an increaseof serious ADR, group evaluation of adverse drug events investigation andverification requirements, increasing the "drug focus on monitoring requirements,"and producers take the initiative to carry out monitoring the work of a clearer andhigher requirements.Studies have shown that the status quo, ADR monitoring Henan Province afterthe edition11"measures" to implement made great breakthroughs, such as thenumber of reports increased year by year, the quality of reports has also beenimproved, Henan drug monitoring department appears in the collection process forreporting problems of medical institutions, enterprises and the public have takeneffective measures to make Henan Province in recent years to collect reports onadverse reactions quantity and quality have made remarkable achievements; Henan testing organizations gathered ADR should be reported The vast majority of datafrom medical institutions, enterprises in Henan Province reported ADR Thisinitiative is not high on the2012CFDA ADR reported in the annual report isconsistent,Study shows that China about adverse drug reactions regulatory laws andregulations matures, but compared with the US, EU and ICH-related laws andregulations of the system is not perfect yet exist, for example, due to changingregulatory requirements and the regulatory situation and the development of theemergence of regulatory laws lag, out of touch with the reality of the new situation,adverse drug reactions regulatory rank is not high, supporting regulations areincomplete, the victim of adverse reactions difficult to obtain relief.Literature shows that there are many problems in the implementation of version2011"approach" the process, such as reporting quality, and enterprise reporting rateis too low,"approach" operability is not strong, and way of supporting laws andregulations, such as missing.Conclusion: ADR monitoring should improve our work-related laws andregulations, improve the quality of medical institutions ADR reporting, enhancedmonitoring of the level of monitoring technology sector, strengthen the supervisiondepartment issued an alert on drug safety risks related information; Therefore, Chinashould learn from ADR monitoring advanced foreign experience and the reality ofour country, to explore a scientific and reasonable adverse drug reaction reportingand monitoring management.