Global Market Report 17-059 Global Market Report 중동의약품 시장동향및진출전략
C O N T E N T S 목 차 요약 / 1 Ⅰ. 중동의약품시장개요 / 3 Ⅱ. 국가별시장현황및특징 / 8 8 20 41 71 83 114 135 147 162 190 1. 터키 2. 이란 3. 이집트 4. 요르단 5. 아랍에미리트 6. 사우디 7. 이라크 8. 이스라엘 9. 쿠웨이트 10. 카타르 Ⅲ. 시사점및진출전략 / 208 Ⅳ. 참고자료 / 210 210 214 217 221 1. 인허가기관 2. 기타협회, 유용한사이트 3. 관련전시회 4. 의약품수입주요에이전트
Global Market Report 17-059 요약 - 1 -
중동의약품시장동향및진출전략 - 2 -
Global Market Report 17-059 Ⅰ 중동의약품시장개요 - 3 -
중동의약품시장동향및진출전략 - 4 -
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중동의약품시장동향및진출전략 Ⅱ 국가별시장현황및특징 1. 터키 - 8 -
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중동의약품시장동향및진출전략 2. 이란 - 20 -
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Global Market Report 17-059 3. 이집트. - 41 -
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중동의약품시장동향및진출전략. Source: Food and Drug Administration (FDA) - 60 -
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중동의약품시장동향및진출전략 1) UAE 건국 50 주년기념중장기국가발전계획 - 86 -
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중동의약품시장동향및진출전략 2) Medicaments, In Measured Doses, Etc. (Excluding Vaccines, Etc., Coated Bandages Etc. And Pharmaceutical Goods) 3) Medicaments (Excluding Vaccines, Bandages And Pharmaceutical Goods) Nesoi, Of Two Or More Mixed Constituents, Not In Measured Doses, Etc 4) Wadding, Gauze, Bandages And Similar Articles, Impregnated Or Coated With Pharmaceutical Substances For Medical, Surgical Etc. Purposes, Nesoi - 90 -
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Global Market Report 17-059 1 A 社 ( ) - - -, (, ) - - -. UAE -,, - UAE,. UAE -, ( ) - 3, UAE, - UAE UAE - UAE - UAE Vision 2021, - 95 -
중동의약품시장동향및진출전략 - 2018 2 B 社 ( ) - 17, (electrode) - (, ) - -, ( ) -, - - - - UAE -, - 96 -
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중동의약품시장동향및진출전략 5) 고대인도전통의학. 산스크리트어로 생활의과학 을의미함. - 100 -
Global Market Report 17-059 제조사 한국 에이전트 병원관련전문점 병원 클리닉 약국등 제조사 한국 해외지사 병원관련전문점 병원 클리닉 약국등 - 101 -
중동의약품시장동향및진출전략 6) DHCC(Dubai Healthcare City) - 102 -
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중동의약품시장동향및진출전략 9. 쿠웨이트 7) 일인당의약품지출금액 : 쿠웨이트 (251.3USD), 사우디아라비아 (34.414USD), 카타르 (215.7USD), 오만 (151.1USD) - 162 -
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중동의약품시장동향및진출전략 Guidelines for registration of pharmaceutical products According to the ministerial decree 302/80 Documents and materials required for registration and re-registration of a Pharmaceutical company and its products in accordance with ministerial decree. N.B: Legalized must be done by the following: I. Kuwait embassy/consulate in the country of origin and when it is not possible, by an authorized Arabian embassy/consulate in the country II. Arab chamber of commerce of the country of origin. III. Kuwait chamber of commerce. * * Legalized is applied to the affiliated branches too. N.B: file should be submitted in CTD format according to ICH guidelines. See annexe (1) 1. Company registration: 1.1. Legalized letter of appointment from company (Stating that the agent is the sole exclusive agent in Kuwait.). 1.2. Original legalized Manufacturing License from country of origin for each manufacturing site issued from ministry of health in country of origin. 1.3. Original legalized Good Manufacturing Practice (GMP) from country of origin. (Not older than 2 years) 1.4. Site master file must contain the following: 1.4.1. General information & history of the company including registered 1.4.2. capital & turnover for the past 3 years 1.4.3. Layout and diagrams of manufacturing sites. 1.4.4. Quality control unit & quality management. 1.4.5. Personnel information including number of employees in each department and their qualifications. 1.4.6. Premises & equipments which include manufacturing sites owned by company, manufacturing lines, and equipments. 1.4.7. List of products manufactured by the company and exporting countries. - 184 -
Global Market Report 17-059 1.4.8. Distribution problems, complaints, product defects and recalls from any authorities worldwide. 1.4.9. Contract manufacturing information 1.4.10. FDA, EMEA, GCC or any recognized global approvals for the company. 2. Product registration: 2.1. Original legalized Certificate of pharmaceutical product (CPP) for each pharmaceutical product in accordance with World Health Organization (WHO) recommended format issued from ministry of health in the country of origin. See annexe (2) for detailed information about CPP 2.2. Original legalized Price certificate issued from the country of origin, and showing the following: 2.2.1. Ex-Factory price. 2.2.2. Whole sale price in the country of origin. 2.2.3. Public price in the country of origin. 2.2.4. C & F unit price for Kuwait. 2.2.5. C & F unit price for the GCC countries and retail price in UAE. 2.3. Legalized declaration - for Innovators companies- of patent expiry date& patent no. of the innovator product from the country of origin, USA (if available in US) and EU (if available in EMEA),legalized by Chamber of Commerce and with supportive documents from patent office should be submitted according to the Ministerial Regulation No. 675/1998, in order to reserve the rights of the innovator company. 2.4. Certificate of composition, mentioning the active and inactive ingredient (excipients, preservatives, coloring materials, flavoring agents, etc.. ) with their quantities. 2.5. Source of supply of all ingredients (active & inactive) 2.6. Raw materials specification (Pharmacopeia reference.) 2.7. Certificate of suitability for any ingredient from animal origin (TSE/BSE certificate) 2.8. Alcohol content declaration See annex (3) - 185 -
중동의약품시장동향및진출전략 2.9. Detailed Finished Product Specification and standards / (End of shelf life, Finished product specification), laid down by the manufacturer, with limits for the respective tests for each pharmaceutical product, together with its method of analysis in details. When the product is the subject of a monograph in the Pharmacopeia it is sufficient to refer the page, edition and name of the Pharmacopeia concerned if it is issued in Arabic or English, a photocopy of the page or pages referring to the product and an Arabic or English, translation is required. see annex (4) 2.10. Reference standard of the active ingredients and related substances with certificate of analysis to be submitted with their specification in full detail to be used as standard in the assay and identification. It should be labeled by generic name and batch number, manufacturing date, expiry date, storage conditions and chemical potency. Reference standard of preservatives (if the product contains these preservatives) or any by- products (if any) should be submitted with the same label requirement of the standard. 2.11. Quantities of samples of the product to be submitted with the documents should be in their original packs and have the same batch number to be registered should be made available to the Pharmaceutical & Herbal Medicines Registration & Control Administration. In amounts as requested to carry out analysis of the product according to the requirements of the specification and method of analysis. 2.12. Certificate of analysis in full detail for the finished product (for the same batch to be registered). 2.13. Batch manufacturing records to be submitted for the same batch of the product to be registered. 2.14. The pack label: should be printed with: 2.14.1. Name of the product. 2.14.2. Name of the manufacturer and country of origin. 2.14.3. Batch or lot number. 2.14.4. Manufacturing date. 2.14.5. Expiry date. 2.14.6. Storage conditions. 2.14.7. Name of the Pharmacopeia (for the Pharmacopoeial product). 2.14.8. Above information on stickers is not approved / allowed. 2.14.9. All information on sample label, container and package insert - 186 -
Global Market Report 17-059 (leaflet) must be in English or in both English and Arabic. 2.15. Leaflet should include the following information: 2.15.1. Enclosed leaflet must be in readable text size, understandable language (English or English/Arabic), and ordered headings for ease of navigation, full and comprehensive information in consistency with Sm.P.C. 2.15.2. Description; product name, strength, dosage form, active substance, list of excipients, warning about certain excipient such as lactose. 2.15.3. Indication, use and Clinical pharmacology. 2.15.4. Dosage and method of administration.( may illustrated with pictograms and symbols) 2.15.5. Warnings and precaution.( boxed warnings maybe added at the top of leaflet) 2.15.6. Contraindications. 2.15.7. Use in specific populations. ( pregnancy, nursing mothers, pediatric, geriatric) 2.15.8. Adverse reactions. 2.15.9. Over dosage. 2.15.10. Drug interaction /Laboratory test interaction. 2.15.11. Drug abuse /dependence. 2.15.12. Non clinical toxicology. 2.15.13. Clinical studies. 2.15.14. How supplies /storage and handling. 2.15.15. Name &address of marketing authorization holder. 2.15.16. Date of last revision 2.16. Stability studies as per ICH guidelines for climatic zone III & IIV 2.16.1. Batch Type and Size: 2.16.1.1. Stability studies should be provided for three batches of the same formulation and dosage form in the container closure system proposed for marketing. 2.16.1.2. Two of the three batches should be at least pilot scale (1), the third batch may be smaller. 2.16.1.3. Batch type and size should be mentioned in stability study protocol. 2.16.2. Raw data of the study must be in tabulated form. - 187 -
중동의약품시장동향및진출전략 2.16.3. Study conditions: 2.16.3.1.. General case / non specific studies: Study Storage conditions Minimum time period at submission Long term 30 ºC ± 2 ºC / 65 ± Complete shelf life. 5%RH Accelerated 40 ºC ± 2 ºC /75 ± 6 months 5%RH 2.17. Pharmacological, toxicological, clinical & no clinical studies and reports of the product, with published papers from international journals as to te safety and clinical efficacy of the product. 2.18. A signed commitment to provide Kuwait food and control with a post marketing surveillance reports and any safety reports or ADRs report which the company may recerivce from users or healthcare professionals. 2.19. Pharmaceutically equivalent multi-source pharmaceutical product(generic) needs to conform the same standards of quality, efficacy and safety of the originator, several test methods are available to therapeutic equivalence : 2.19.1. Bioequivalence studies in Humans. 2.19.2. Comparative Pharmaco-dynamic studies in Humans. 2.19.3. Comparative Clinical studies. 2.19.4. In-vitro dissolution studies. Applicability of each of these four modalities is discussed later, See Annexe(5) 2.20. Biosimiler products require additional documents, see annexe(6) 2.21. Any change in the name of the manufacturer, product, shape of pack, specifications, shelf life, composition or leaflet of the product should be handled with logical reasons or scientific explanations. For detailed types of changes and required documents, See Annexe(7) - 188 -
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Global Market Report 17-059 주요 일반 의약품 가격 동향 <주요 일 상품사진(상품명) 반 의약품 가격 동향> 복제약명 제조사 포장 소매가격 이저 IBuprofen 200mg/ 파(Pfizer QAR Pseudoephedrine Canada Inc) 20정/박스 12.25 (3.4USD) HCI 30mg /캐나다 (Advil Cold & Sinus) Paracetamol (Tylenol Forte) (Gaviscon) 얀센 8QAR (Janssen) 20정/박스 (2.2USD) /스위스 Sodium alginate 500 mg/10ml 레킷벤키저 Sodium Hydrogen (Reckitt 11.75QAR Carbonate 200ml / 병 Bencki s er 267mg/10ml Healthcare) (3.2USD) Calcium Carbonate /영국 160mg/10ml 주 : 1 USD = 3.64 QAR 자료원 : 공공보건부(MoPH), KOTRA 도하무역관 자료 - 199 -
중동의약품시장동향및진출전략 - 200 -
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중동의약품시장동향및진출전략 Ⅲ 시사점및우리기업진출전략 - 208 -
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중동의약품시장동향및진출전략 Ⅳ 참고자료 - 210 -
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Global Market Report 17-059
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작성자 중동지역본부 도하무역관 두바이무역관 리야드무역관 바그다드무역관 암만무역관 이스탄불무역관 카이로무역관 쿠웨이트무역관 테헤란무역관 텔아비브무역관 전략시장진출지원단 이광일이용호안령이성길김성재문선호권오륭김지혜송세현박재영조경진남다현 Global Market Report 17-059 중동의약품시장동향및진출전략 발행인발행처발행일주소전화홈페이지문의처 I S B N 김재홍 KOTRA 2017년 12월서울시서초구헌릉로 13 (06792) 02-1600-7119( 대표 ) www.kotra.or.kr 전략시장진출지원단 (02-3460-3386) 9 7 9-1 1-6 0 9 7-5 0 3-1 (95320) Copyright c 2017 by KOTRA. All rights reserved. 이책의저작권은 KOTRA에있습니다. 저작권법에의해한국내에서보호를받는저작물이므로무단전재와무단복제를금합니다.
중동의약품시장동향및진출전략 Global Market Report