• Development and Reproduction
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• v.21 no.3
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• pp.343-349
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• 2017

tWith the development of the third-generation gene scissors, CRISPR-Cas9, concerns are being raised about ethical and social repercussions of the new gene-editing technology. In this situation, this article explores the legislation and interpretation of the positive laws in South Korea. The BioAct does not specify and regulate 'gene editing' itself. However, assuming that genetic editing is used in the process of research and treatment, we can look to the specific details of the regulations for research on humans as well as gene therapy research in order to see how genetic editing is regulated under the BioAct. BioAct differentiates the regulation between (born) humans and embryos etc. and the regulation differ entirely in the manner and scope. Moreover, due to the fact that gene therapy products are regarded as drugs, they fall under different regulations. The Korean Pharmacopoeia Act put stringent sanctions on clinical trials for gene therapy products and the official Notification "Approval and Examination Regulations for Biological Products, etc." by Food and Drug Safety Administration may be applied to gene editing for gene therapy purposes.

• Korean Journal of Biological Psychiatry
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• v.23 no.2
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• pp.48-56
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• 2016

Alzheimer's disease (AD) is a neurodegenerative disorder in which neuronal loss causes cognitive decline and other neuropsychiatric problems. It can be diagnosed based on history, examination, and appropriate objective assessments, using standard criteria such as the Diagnostic and Statistical Manual of Mental Disorders or the National Institute of Neurological and Communicative Disorders and Stroke and the Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA). Brain imaging and biomarkers are making progress in the differential diagnoses among the different disorders. The cholinesterase inhibitors, donepezil, rivastigmine and galantamine and N-methyl-D-aspartate receptors antagonist memantine are approved by the US Food and Drug Administration for AD. Recently some acetylcholinesterase inhibitors gained approval for the treatment of severe AD and became available in a higher dose formulation or a patch formulation. Optimal care in AD is multifactorial and it should include early diagnosis and multidisciplinary care with pharmacological and nonpharmacological interventions including exercise interventions, cognitive interventions and maintenance of social networks.

• Journal of Dental Rehabilitation and Applied Science
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• v.30 no.3
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• pp.231-237
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• 2014

Botulinum toxin has been used for treating chronic migraine under US Food and Drug Administration approval since 2010. However there is no definitive guideline for injection point. The aim of this study is to propose an effective and safe injection guideline by reviewing the previous studies.

• Archives of Plastic Surgery
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• v.39 no.6
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• pp.585-592
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• 2012

During the past decade, many studies using platelet-rich plasma (PRP) or adipose-derived stem cells (ASCs) have been conducted in various medical fields, from cardiovascular research to applications for corneal diseases. Nonetheless, there are several limitations of practical applications of PRP and ASCs. Most reports of PRP are anecdotal and few include controls to determine the specific role of PRP. There is little consensus regarding PRP production and characterization. Some have reported the development of an antibody to bovine thrombin, which was the initiator of platelet activation. In the case of ASCs, good manufacturing practices are needed for the production of clinical-grade human stem cells, and in vitro expansion of ASCs requires approval of the Korea Food and Drug Administration, such that considerable expense and time are required. Additionally, some have reported that ASCs could have a potential risk of transformation to malignant cells. Therefore, the authors tried to investigate the latest research on the efficacy and safety of PRP and ASCs and report on the current state and regulation of these stem cell-based therapies.

• Journal of Veterinary Clinics
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• v.35 no.4
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• pp.119-125
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• 2018

In vitro diagnostic veterinary medical reagents (IVDVMRs) were diverted the medical devices from medicine by the revision of the pharmaceutical affairs act enforcement regulations in 2015 in Korea. It classified into class I-IV according to risks of individual and public health. However, good manufacturing practices requirements on IVDVMRs were exempted from the current system. The registration of IVDVMRs by the Animal and Plant Quarantine Agency has gradually increased since 2012, and total of 584 products from 68 companies were registered from 1978 to 2017. Most of these items are clinical immunochemistry (infection disease), clinical immunochemistry (non-infection disease), molecular genetics, endocrinology, blood gas analysis, clinical microbiology, toxin, heavy metal and drug of abuse, other etc. The market size of IVDVMRs reported from the Korea Animal Health Products Association was estimated to be approximately 51.9 billion won in 2017. The domestic consumption and the export sales were approximately 31.2 and 20.7 billion won, respectively. They are increasing 23.9% (CAGR) in domestic consumption and 40.4% (CAGR) in export from 2011 to 2017.

• Asian-Australasian Journal of Animal Sciences
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• v.12 no.2
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• pp.233-243
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• 1999

Food safety or sanitation are terms broadly applicable to procedures designed to ensure that food quality is high and free of factors which may adversely affect human health. These factors include zoonotic diseases and acute and chronic effects of ingesting natural and human-made xenobiotics. Use of drugs in animal production for the treatment and control of animal diseases, to promote growth rate, and to improve feed conversion efficiency has expanded year by year, thus increasing the possibilities for occurrences in animal products of residues harmful to humans. Governmental agencies have made efforts to control or prevent residue problems. The Korean Food and Drug Administration (KFDA) is charged with the responsibility of establishing tolerances for veterinary drugs, pesticides, and mycotoxins and other non-pharmaceutical substances. The Department of Veterinary Service is responsible for establishing guidelines regarding withdrawal times of drugs, approval of drugs, their uses, and sanitation enforcement of livestock products. The authors describe the toxicological basis for the establishment of tolerance levels for xenobiotics and the pharmacokinetic basis for establishing withdrawal time for veterinary drugs. The regulatory tolerance levels of chemicals in pork and swine feed, Korean regulations on the use of feed additives, rapid residue test methods, the National Residue Program, and the Food Animal Residue Avoidance Databank are discussed. Rapid EIA methods that are under development for the screening of live animals are described These methods predict tissue residues from an examination of blood samples taken from pigs before they are slaughtered.

• Journal of Dental Rehabilitation and Applied Science
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• v.29 no.4
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• pp.391-398
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• 2013

Botulinum toxin has been used for treating strabismus, blepharospasm, cerebral palsy, cervical dystonia, hyperhydrosis, facial wrinkle and chronic migraine under US Food and Drug administration approval. Also it has been tried spasticity-induced pain, post-herpetic neuralgia, myofascial pain and aphthous ulcer as off-label use. In this study, we reviewed recent studies that suggested effects of botulinum toxin on snoring and sleep apnea.

• Genomics & Informatics
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• v.12 no.4
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• pp.151-155
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• 2014

In November 2013, the US Food and Drug Administration (FDA) sent a warning letter to 23andMe, Inc. and ordered the company to discontinue marketing of the 23andMe Personal Genome Service (PGS) until it receives FDA marketing authorization for the device. The FDA considers the PGS as an unclassified medical device, which requires premarket approval or de novo classification. Opponents of the FDA's action expressed their concerns, saying that the FDA is overcautious and paternalistic, which violates consumers' rights and might stifle the consumer genomics field itself, and insisted that the agency should not restrict direct-to-consumer (DTC) genomic testing without empirical evidence of harm. Proponents support the agency's action as protection of consumers from potentially invalid and almost useless information. This action was also significant, since it reflected the FDA's attitude towards medical application of next-generation sequencing techniques. In this review, we followed up on the FDA-23andMe incident and evaluated the problems and prospects for DTC genetic testing.

• YAKHAK HOEJI
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• v.57 no.6
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• pp.432-441
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• 2013

It's been almost 20 years since the adoption of Good Manufacturing Practices (GMP) in Korea since 1994. There have been big progresses in the GMP regulations and its implementations. 'New GMP' in 2008 has adopted validation, pre-approval GMP evaluation, annual quality review, etc.. Upon the submission of PIC/S (Pharmaceutical Inspection Cooperation Scheme) application by Korea's Ministry of Food and Drug Safety in April, 2012, Korea is facing new opportunity to level up Korea GMP regulations. As such, this study suggested GMP revision points by comparing and analyzing the differences between PIC/S GMP and Korea GMP. Those areas which GMP is not required such as radiopharmaceuticals and medical gases should adopt GMP. And independent GMP regulation is needed for Active Pharmaceutical Ingredients and investigational medicinal products. Also, those regulations shall be implemented in the higher level of legal status. Finally, rather than pursuing GMP harmonization only for PIC/S membership, GMP improvement in the long term shall be taken into consideration by reflecting current quality issues such as ICH Q8 (Pharmaceutical development), Q9 (Quality Risk Management) and Q10 (Pharmaceutical Quality System).

• Journal of Korean Neurosurgical Society
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• v.62 no.1
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• pp.10-26
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• 2019

Magnetic resonance-guided focused ultrasound (MRgFUS) is an emerging new technology with considerable potential to treat various neurological diseases. With refinement of ultrasound transducer technology and integration with magnetic resonance imaging guidance, transcranial sonication of precise cerebral targets has become a therapeutic option. Intensity is a key determinant of ultrasound effects. High-intensity focused ultrasound can produce targeted lesions via thermal ablation of tissue. MRgFUS-mediated stereotactic ablation is non-invasive, incision-free, and confers immediate therapeutic effects. Since the US Food and Drug Administration approval of MRgFUS in 2016 for unilateral thalamotomy in medication-refractory essential tremor, studies on novel indications such as Parkinson's disease, psychiatric disease, and brain tumors are underway. MRgFUS is also used in the context of blood-brain barrier (BBB) opening at low intensities, in combination with intravenously-administered microbubbles. Preclinical studies show that MRgFUS-mediated BBB opening safely enhances the delivery of targeted chemotherapeutic agents to the brain and improves tumor control as well as survival. In addition, BBB opening has been shown to activate the innate immune system in animal models of Alzheimer's disease. Amyloid plaque clearance and promotion of neurogenesis in these studies suggest that MRgFUS-mediated BBB opening may be a new paradigm for neurodegenerative disease treatment in the future. Here, we review the current status of preclinical and clinical trials of MRgFUS-mediated thermal ablation and BBB opening, described their mechanisms of action, and discuss future prospects.