Regulation of Cell and Gene Therapy Medicinal Products in Taiwan.

Owing to the rapid and mature development of emerging biotechnology in the fields of cell culture, cell preservation, and recombinant DNA technology, more and more cell or gene medicinal therapy products have been approved for marketing, to treat serious diseases which have been challenging to treat with current medical practice or medicine. This chapter will briefly introduce the Taiwan Food and Drug Administration (TFDA) and elaborate regulation of cell and gene therapy medicinal products in Taiwan, including regulatory history evolution, current regulatory framework, application and review procedures, and relevant jurisdictional issues. Under the promise of quality, safety, and efficacy of medicinal products, it is expected the regulation and environment will be more flexible, streamlining the process of the marketing approval of new emerging cell or gene therapy medicinal products and providing diverse treatment options for physicians and patients.

Regulation of New Drug Approval in Taiwan.

Taiwan Food and Drug Administration (TFDA) was established in 2010 as the nation's principal consumer product protection agency of food, drugs, medical devices, and cosmetics. By integrating 4 agencies (the Bureau of Food Safety, Bureau of Pharmaceutical Affairs, Bureau of Food and Drug Analysis, and Bureau of Controlled Drugs), TFDA holds the mission of protecting and promoting the public health through regulation modernization to enhance the availability of safe medical products and foods. To address the unmet medical needs and public health, TFDA has utilized regulatory science to evaluate review principles and risk management to properly oversee the overall life cycle of medicinal products. A lot of measures have been accomplished to build an efficient, transparent, and internationally harmonized regulatory system. With the first-in-the-world new drug afatinib approved in Taiwan, TFDA has successfully built up capacity and capability in the review and approval of new drugs. This article summarizes the efforts TFDA has been making in the domain of medicinal product management, highlighting policies and strategies for the future.

Identification and quantification of Cu-chlorophyll adulteration of edible oils.

Cu-pyropheophytin a, the major Cu-pigment of Cu-chlorophyll, was determined in edible oil by high-resolution mass spectrometry with a high-performance liquid chromatography-quadrupole (HPLC-Q)-Orbitrap system and by HPLC coupled with a photodiode-array detector. Respective limit of detection and limit of quantification levels of 0.02 µg/g and 0.05 µg/g were obtained. Twenty-nine commercial oil products marked as olive oil, grapeseed oil and blended oil, all sourced directly from a food company that committed adulteration with Cu-chlorophyll, were investigated. In this company, four green dyes illegally used in oils were seized during factory investigation by the health authorities. The food additive Cu-pyropheophytin a was found in all confiscated samples in concentrations between 0.02 and 0.39 µg/g. Survey results of another 235 commercial oil samples manufactured from other companies, including olive pomace oil, extra virgin olive oil, olive oil, grapeseed oil and blended oil, indicated high positive incidences of 63%, 39%, 44%, 97% and 8%, respectively, with a concentration range between 0.02 and 0.54 µg/g. High Cu-chlorophyll concentrations are indications for fraudulent adulteration of oils.

Stress, depression, and intention to leave among nurses in different medical units: implications for healthcare management/nursing practice.

AIMS: The aim of the present study was to compare the levels of stress, depression, and intention to leave among clinical nurses employed in different medical units in relation to their demographic characteristics under the National Health Insurance (NHI) System in Taiwan. METHODS: Cross-sectional Spearman's correlation, one-way ANOVA with Scheffe post hoc analysis tests, and multiple regression analyses were conducted. Several self-report questionnaires, such as the Center for Epidemiological Studies Depression Scale, the Perceived Stress Scale and Intention to Leave Scale, were administered. A total of 314 research participants were surveyed, all of whom came from regional hospitals in Northern Taiwan. RESULTS: Marital status and working tenure were significant predictors to the levels of stress, depression, and intention to leave among nurses before taking the medical units into consideration. However, with adding medical units as predictors, the effect of marital status and working tenure were insignificant except for the stress model, indicating medical units were showing dominant effect over other variables. In particular, internal medical ward (IMW) nurses experienced a higher prevalence of depression than emergency room (ER) nurses and professional nursing practitioners. External medical ward (EMW) nurses also experienced greater depression than emergency room (ER) nurses. Both IMW and EMW nurses perceived significantly greater stress than ER and dialysis center. Moreover, IMW nurses also perceived greater stress than operating room (OR) nurses and showed stronger intention to leave than their counterparts in the outpatient service departments. CONCLUSIONS: The results indicated that significant differences existed among various medical units with regards to nurses' stress, depression, and intention to leave. Nurses working in internal and external medical wards, especially the inexperienced and married ones, experienced greater depression and stress, thereby developing stronger intention to leave their job.