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Dong Young Shin
Partner
- TEL 82 2 6182 8550
- FAX 8 2 6003 7031
- E-MAIL dyshin@yoonyang.com
Biography
Dong Young Shin is a partner at Yoon & Yang LLC, and her main practice area is biohealth.
Prior to joining our law firm, Ms. Shin worked as a legal expert at the Ministry of Health and Welfare (MOHW), during which she provided anaological statutory interpretations related to administrative dispositions and litigations against medical professionals and institutions, advised on relevant matters and handled legislative amendments. Thereafter, she worked as an in-house counsel at the Jeonin Education Center (an institution that provides education and training on character building and leadership). She also served in various positions at the National Institute of Food and Drug Safety Evaluation (Drug Review Department) and the Ministry of Food and Drug Safety (Convergence Technology Policy Team, Biopharmaceutical Policy Division, and Regulatory Reform and Legal Affairs Office), during which she advised on relevant matters, providing consulting on administrative litigations and dispositions, and handled legislative establishment and amendments.
Ms. Shin has ample experience in advising on laws and regulations managed by the Ministry of Food and Drug Safety (MFDS) related to food, pharamceuticals (quasi-drugs), medical devices and cosmetics, as well as laws and regulations managed by the MOHW such as the Medical Service Act and the National Health Insurance Act. She is also well-versed in responding to administrative investigations, dispositions, litigations and relevant criminal procedures of the MOHW, MFDS, and local autonomous bodies. Furthermore, Ms. Shin has experience handling numerous litigations and providing advisoy service pertaining to licensing and permits, screening, and good manufacturing practice (GMP) of food, pharmaceuticals (quasi-drugs), medical devices, and cosmetics. Her profound expertise was accumulated during her years working at government agencies where she advised and handled litigations related to health & welfare and pharmaceutical & bio sectors, enabling her to deliver optimal strategies and solutions befitting each case.
Prior to joining our law firm, Ms. Shin worked as a legal expert at the Ministry of Health and Welfare (MOHW), during which she provided anaological statutory interpretations related to administrative dispositions and litigations against medical professionals and institutions, advised on relevant matters and handled legislative amendments. Thereafter, she worked as an in-house counsel at the Jeonin Education Center (an institution that provides education and training on character building and leadership). She also served in various positions at the National Institute of Food and Drug Safety Evaluation (Drug Review Department) and the Ministry of Food and Drug Safety (Convergence Technology Policy Team, Biopharmaceutical Policy Division, and Regulatory Reform and Legal Affairs Office), during which she advised on relevant matters, providing consulting on administrative litigations and dispositions, and handled legislative establishment and amendments.
Ms. Shin has ample experience in advising on laws and regulations managed by the Ministry of Food and Drug Safety (MFDS) related to food, pharamceuticals (quasi-drugs), medical devices and cosmetics, as well as laws and regulations managed by the MOHW such as the Medical Service Act and the National Health Insurance Act. She is also well-versed in responding to administrative investigations, dispositions, litigations and relevant criminal procedures of the MOHW, MFDS, and local autonomous bodies. Furthermore, Ms. Shin has experience handling numerous litigations and providing advisoy service pertaining to licensing and permits, screening, and good manufacturing practice (GMP) of food, pharmaceuticals (quasi-drugs), medical devices, and cosmetics. Her profound expertise was accumulated during her years working at government agencies where she advised and handled litigations related to health & welfare and pharmaceutical & bio sectors, enabling her to deliver optimal strategies and solutions befitting each case.
Practice Areas
Experience
- 2024-present Yoon & Yang LLC
- 2025-present Member, Advisory Committee, Korea Pharmaceutical Information Center
- 2017-24 Examiner, National Institute of Food and Drug Safety Evaluation
- 2017 In-house Counsel, Center for Human Completion
- 2015-16 Legal Expert, Ministry of Health and Welfare
- 2013-14 Pharmacist, Gangdong Seongsim Hospital
Education
- 2014 Sungkyunkwan University Law School (J.D.)
- 2011 Sungkyunkwan University (B.S. in Pharmacy)
Qualifications
- Admitted to bar, Korea (2015)
- Pharmacist, Korea (2011)
Representative Matters
[Pharmaceutical & Bio]
- Advised Dong-A ST on the designation as an “innovative pharmaceutical company” and the development of innovative new drugs
- Advised Boryung Pharm on government support projects for antibiotics and successfully assisted in the selection of the project
- Advised Medytox on response to the MFDS’s administrative disposition involving Botulinum Toxin products
- Handled criminal litigation related to Medytox’s Botulinum Toxin products
- Advised Medytox on approval for export of national core technology by the Ministry of Trade, Industry and Energy (MOTIE)
- Advised Alteogen on pharmaceutical advertisements and review of licensing and marketing rights agreements
- Advised Hanmi Pharm on pharmaceutical GMP compliance
- Advised Bukwang Pharm on pharmaceutical advertising, business transfer, wholesale agreements, and joint R&D agreements
- Advised Huons Global on pharmaceutical wholesale, export, production, research, and sales-related matters
- Advised Hutecs on pharmaceutical plant and product item approvals, and GMP transfer
- Advised Jetema on pharmaceutical export-related matters
- Advised Ferring Pharmaceuticals Korea on fast-track review and conditional approval of orphan drugs
- Advised Galderma Korea on patient support programs
- Provided regular legal advisory services to Samcheondang Pharm
- Provided legal advice to SMT Bio regarding human cell-related matters
- Advised Maseong LS on the import of chemical raw material samples
- Advised Medimap Bio on review of CDA and MSA agreements
- Advised Trivo on review of patent assignment agreements
- Advised Zentalis Pharmaceuticals on review of clinical trial service agreements
- Advised on the transfer and acquisition of pharmaceuticals
- Handled criminal matters related to the Narcotics Control Act and successfully obtained a disposition of no charges
- Represented clients in litigation seeking revocation of GMP eligibility determinations and suspension of execution
- Handled responses to MFDS administrative dispositions arising from rebate practices
- Provided consulting services regarding certification as an innovative pharmaceutical company
- Advised on MFDS approval, review procedures, and responses to supplementary requests for pharmaceutical products
- Advised on bioequivalence testing of pharmaceuticals
- Advised on Drug Master File (DMF) matters for active pharmaceutical ingredients (APIs)
- Advised on pharmaceutical product naming matters
- Advised on pharmaceutical unit packaging requirements
- Advised on MFDS responses regarding conditional approval of orphan drugs
- Advised on clinical trial efficacy endpoints for orphan drugs
- Advised on matters related to the Human Tissue Act
[Medical Device]
- Advised Osstem Implant on the Medical Service Act, Pharmaceutical Affairs Act, and Medical Device Act
- Advised Nestle Korea on medical device licensing and approval
- Advised GE HealthCare on digital medical devices
- Advised Pharma Research on advertising of Rejuran and responses regarding counterfeit products
- Advised on medical device product licensing, including stents
- Advised on responses to the MFDS regarding medical device modification approvals and successfully obtained approval
- Advised on the new health technology assessment process for medical devices
- Advised on legal issues related to AI software as a medical device
- Advised on medical device performance reporting obligations
[Food]
- Advised Harim Group on food-related compliance matters, including the Food Sanitation Act and the Act on Fair Labeling and Advertising of Foods
- Advised Nestle Korea on the sale of health functional foods
- Advised Goobne Chicken on standards and specifications under the Korean Food Code
- Advised on food labeling and advertising regulations applicable to alcoholic beverage labels and advertisements
- Represented clients in criminal investigations by the National Agricultural Products Quality Management Service regarding the Act on Origin Labeling of Agricultural and Fishery Products and successfully obtained a disposition of no charges
- Handled responses to MFDS administrative dispositions related to imported food declarations
- Advised on functional ingredients and individually recognized functional ingredients for health functional foods
- Handled responses to MFDS administrative dispositions arising from violations of the Special Act on Imported Food Safety Control
- Advised Barista Bar & Coworking Office on business registration under the Food Sanitation Act
- Handled criminal responses regarding misleading advertisements implying pharmaceutical efficacy and exaggerated advertisements
[Cosmetics]
- Advised Pharma Research on PDRN cosmetic advertising and counterfeit products
- Advised on responses to MFDS administrative dispositions related to cosmetic and food advertisements
- Advised on responses to exaggerated cosmetic advertisements
[Health & Medical Care]
- Advised SK Bioscience and Yuyu Pharm on responses to the national health insurance adequacy reassessment of pharmaceuticals and successfully assisted in exclusion from the reassessment process
- Handled responses to business suspension dispositions arising from excessive claims for medical care benefits and successfully resolved the matter
- Represented clients in matters involving responses to the Ministry of Health and Welfare (MOHW) under the National Health Insurance Act
- Advised on warehouse-type pharmacies
Awards
- Ministerial Commendation, Merit for Medical Device Safety Management, Ministry of Food & Drug Safety (2023)
- Ministerial Commendation, Merit for Food Sanitation Improvement, Ministry of Food & Drug Safety (2021)
- Excellent Employee Commendation, Ministry of Food & Drug Safety (2019)
Publications
[Media Outlets and Academic Journals]
- “Low-priced” warehouse-type pharmacies: potential illegality in online sales and delivery (The Law Times, 2025)
- Legal Measures and Case Studies by Type of Violation of the Pharmaceutical Pre-Approval System, KFDC Journal of Regulatory Science, Vol. 17, No. 2. December, at 95-106 (2022)
[Lectures]
- Delivered a lecture on understanding of pharmaceutical terms and pharmacology at the Korea Pharmaceutical and Bio-Pharma Manufacturers Association (2024)
Languages
Korean and English
