ABSTRACT
Hong Kong is a compact territory in Southern China that enjoys a high degree of autonomy. Despite its dense population and uneven wealth distribution, infant mortality is low and life expectancy is long. The health service is more hospital and clinic based than community based. This seems cost-effective while professional standards are high and rigorously maintained. Drug registration follows American and European requirements. Hong Kong is a part of the Pharmaceutical Inspection Cooperation Scheme, which brings a high standard of drug regulation. Hong Kong is a good choice for clinical trials because the subjects are Chinese and protocols in English do not need to be translated. There are also 2 well-established clinical trials centers in university hospitals that also run Phase I and clinical pharmacology studies.
Subject(s)
Clinical Trials as Topic , Pharmacology, Clinical , Drug Approval , Health Services/standards , Hong Kong , Humans , Quality of Health CareABSTRACT
In Japan, a research center network consisting of Kyoto University to provide clinical-grade induced Pluripotent Stem Cells (iPSC) and several major research centers to develop iPSC-based regenerative therapies was formed for the clinical application of iPSCs. This network is under the supervision of a newly formed funding agency, the Japan Agency for Medical Research and Development. In parallel, regulatory authorities of Japan, including the Ministry of Health, Labour and Welfare, and Pharmaceuticals and Medical Devices Agency, are trying to accelerate the development process of regenerative medicine products (RMPs) by several initiatives: 1) introduction of a conditional and time-limited approval scheme only applicable to RMPs under the revised Pharmaceuticals and Medical Devices Act, 2) expansion of a consultation program at the early stage of development, 3) establishment of guidelines to support efficient development and review and 4) enhancement of post-market safety measures such as introduction of patient registries and setting user requirements with cooperation from relevant academic societies and experts. Ultimately, the establishment of a global network among iPSC banks that derives clinical-grade iPSCs from human leukocyte antigens homozygous donors has been proposed. In order to share clinical-grade iPSCs globally and to facilitate global development of iPSC-based RMPs, it will be necessary to promote regulatory harmonization and to establish common standards related to iPSCs and differentiated cells based on scientific evidence.
ABSTRACT
OBJECTIVE: To study the feasibility of conducting hospital pharmaceutical inspection by pharmacy pharmaceutical management group.METHODS: The experience of conducting hospital pharmaceutical inspection including monitoring the drug control in clinical departments,supervising the drug control in pharmacy department and monitoring rational use of drugs was introduced.RESULTS & CONCLUSIONS: Pharmaceutical inspection promoted drug management in pharmacy and clinical departments,improved the rational use of drugs,and strengthened the relationship between pharmacy and clinical departments,which deserves to be popularized.