( 바이오 ) 의약품해외진출지원을위한정보집 - 말레이시아

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1 ( 바이오 ) 의약품해외진출지원을위한정보집 - 말레이시아

2 목 차 1. 국가명 1 2. 의약품규제정보 1 (1) 인허가규제기관 1 (2) 인허가규제정보 7 3. 건강보험및약가제도 13 (1) 보건의료체계 13 (2) 의료보험 14 (3) 약가 15 (4) 의료시설현황 시장정보 17 (1) 경제동향 17 (2) 산업동향 18 (3) 국내제약사진출현황 업체정보 20 (1) 제약협회 20 (2) 무역관 20 (3) 대사관 20 (4) 파트너사리스트 21 (5) 파트너사상세정보 참고문헌 참고사이트 44

3 표목차 표 1. 의약품범주에따른평가기간 9 표 2. QUEST 회원 USB 토큰요금 9 표 3. 수수료 10 표 4. 의료기관구분 16 표 5. GDP 현황 17 표 6. 보건지표 17 표 7. 주요제약기업 19 그림목차 그림 1. MOH 조직도 2 그림 2. DCA 역할 3 그림 3. NPRA 조직도 6 그림 4. ACTD 11 그림 5. 의약품등록절차 12 그림 6. 보건의료서비스체계 13

4 1. 국가명 : 말레이시아 수도 : 쿠알라룸푸르 인구 : 3,095만명 ( 세계 42위, 2016 CIA 기준 ) 민족 : 말레이계 (60%), 중국계 (25%), 인도계 (7%), 기타 (8%) 종교 : 이슬람교 (62%), 불교 (21%), 기독교 (9%), 힌두교 (6%), 기타 (2%) 언어 : 말레이어 면적 : 329,847km 2 ( 세계 67위, CIA 기준 ) 통화 : 링깃 (MYR) GDP : 3,093억달러 ( 세계 34위, 2016 IMF 기준 ) 1인당 GDP : 9,811 달러 ( 세계 61위, 2016 IMF 기준 ) 2. 의약품규제정보 (1) 인허가규제기관 1) 보건부 (MOH, Ministry of Health Malaysia) 가. 임무 - 국민을지원하기위한의료제휴를구축하는업무를전담하고있음 건강의잠재력을완전히달성함 국민이건강을귀중한자산으로여기도록장려함 보다나은삶의질을향유하기위해건강상태를개선및유지하는데적극적인조치를취함 양질의의료제도를확보함 나. 조직 - 보건부는부서의전체프로그램및정책에준용되는일부건강관련법과관련규정의관리에대해의회에책임을짐. 장관휘하에는차관과정무차관, 사무총장을두고있음. 보건부의일상업무는사무총장을통하여운영됨 다. 홈페이지 : 1

5 < 그림 1. MOH 조직도 > * 출처 : Ministry of Health Malaysia( 2) 의약품규제국 (DCA, Drug Control Authority) - 의약품및화장품관리규정 (Control of Drugs and Cosmetics Regulations 1984) 에따라설립된행정기구로서말레이시아에서시판되는의약품, 건강용품, 개인미용용품및위생용품의안전성및유효성, 품질등의확인및규제를총괄하는역할을함 - DCA에서는말레이시아내의모든의약품및화장품에대한관리를하고있음 의약품및화장품의등록 수입업자, 제조사, 도매업자용부지허가 (Licensing of Premises) 시장등록제품의품질감시 약물유해반응감시 2

6 < 그림 2. DCA 역할 > * 출처 : National Pharmaceutical Regulatory Agency Malaysia( index.php/about-npcb/drug-control-authority-dca/information) 년의약품및화장품관리규정에따라 DCA는아래와같은등록제도를시행하고있음 1 단계 : 1952년독극물관리법에서정의하는독약을함유하는의약품 (1986년 11월 1일 ) 2 단계 : 전통의약품을제외하고독약을함유하지않은의약품 (1988년 8월 1일 ) 3 단계 : 전통의약품 (1992년 1월 1일 ) 4 단계 페닐렌디아민과톨루엔디아민, 염류, 유도체가함유된모발염제 (1991년 8월 1일 ) 과산화수소 / 카바마이드퍼옥사이드를함유한치아미백제 (1996년 2월 1일 ) 위의물품을제외한전체화장품 (2002년 2월 1일 ) * 참고 : 화장품등록은 2008년 1월 1일을기준으로신고절차로대체됨 3

7 5 단계 : 동물용의약품 (2007 년 8 월 1 일 ) 6 단계 : 신규화학물질 (NCE) 에대한등록개시 (2012 년 1 월 ) - 아울러 DCA 는전체등록제품이규정된라벨요건에따라표시되도록함 3) 국립의약품관리국 (NPRA, National Pharmaceutical Regulatory Agency, 이전 NPCB, National Pharmaceutical Control Bureau) 년 10월의약품의품질을관리하기위해설립된기관으로, 인류의건강과안녕을보장하기위한의약품규제업무의최고기관 이라는비전을가지고 1985년부터등록및면허제도를통해의약품의품질과안전성및유효성을보장하고있으며, 의약품정보서비스를통하여의료진과소비자에게의약품에관한정보를제공하고있음 - ASEAN 회원국 ( 스리랑카, 방글라데시, 미얀마, 몽골, 베트남등 ) 의임원에게등록절차를소개하고교육과정을제공하여, 1996년 WHO로부터국제적으로 의약품규제단속을위한 WHO 협력센터 로인정받았음 - 주요업무 해외기관의기술데이터와실험실검사, 연구및정보평가를통하여의약품과화장품등록제도시행 의약품의품질과안전성및유효성을보장하기위하여의약품과화장품에대해분석, 약학, 미생물, 약리, 독물검사실시 무작위추출과분석검사의수행을통해시장에출시된의약품의품질에대해규제제도시행 임상시험면허제도를비롯하여제약회사와수입업자, 도매업자에대한면허제도시행 WHO가권장하는 GMP의요건에해당하는수준으로제조기준을업그레이드하도록현지제약회사장려및지원 약물유해반응감시프로그램을관리하고 WHO 국제약물유해반응감시프로그램에참여 수준이하이거나소비자에게위험하다고확인되는의약품에대한의약품리콜제도관리 뉴스레터 Berita Ubat-ubatan 을통해 DCA의정책 / 뉴스에대한정보를배포할뿐아니라온라인등록절차와등록제품에대한정보, NPRA에대한기타문의에대해일반인에게서비스제공 4

8 의약품 / 화장품의품질과안전성및유효성을평가하기위한방법론연구와기초연구수행 ASEAN 회원국간에이루어지는의약품분야의협력제도를통해말레이시아전체와인접국에국한하여사용되는참조표준제도수립 지방교육제도나국제협력제도를통하여수시로본기관에배치되는의약책임자와기타전문가, 기타준전문가의교육수행 - 조직 제품등록센터 : 종전에의약품평가안전성관리부로알려졌으며, 모든시판의약품이안전하고유효하며품질이우수하다는사실을보증하기위해설립되었음. 직원은약 40명으로이가운데 3분의 2는약사임. 동센터는말레이시아국내의약품시판허가신청의평가를담당함. 여기에는신형화학물과생명공학제품, 제네릭의약품, OTC에서부터전통의약품과화장품까지포함됨 품질관리센터 : 시험프로토콜의검토및평가와등록용으로제출된의약품뿐아니라등록후제출되는의약품의품질관리검사를담당함. 동부서는사내용과현지제약산업용화학및생물참조표준을제정함. GMP 관리부와협력하여제약업계검사실검사도수행함 행정사업본부 : 재정과총무, 기타비전문업무에대한현안일체의관리를담당함 등록후센터 : 종전에감시및약물감시부로알려진동부서는 DCA에등록되고말레이시아에시판되는제품이등록전품질표준을준수하고효능이있으며안전하게사용할수있는지확인하는업무를담당함 조직개발센터 : 종전에조직개발및정보기술부로알려진동부서는 1997년설립되었음. 조직개발센터는 NPRA의의약품및화장품평가를위한제품분류를지원하고정보를제공함. 뿐만아니라민 관부문의문의에응대하는국립의약품정보센터로활동함. 동부서는우수한참고서와학술지를소장하고있는도서관을보유하고있음 준법면허센터 : GMP와면허부의주된목표는의약품과전통의약품을생산하는모든국내제조사가 GMP의요건을준수하고의약품수입업자와도매업자가의약품유통관리기준 (GSP) 의요건을준수하는지확인하는데있음. 동부서는그역할과활동범위를달성하기위하여 i) 제 Ⅰ 검사사업단, ii) 제 Ⅱ 검사사업단, iii) GMP 자문서비스사업단, iv) GMP 5

9 연구사업단, v) 면허및인증사업단으로세분화됨. 면허사업단은제조사와수입업자, 도매업자의면허허가신청을처리함 연구용신약센터 : 연구용신약센터는말레이시아국내임상시험감독을담당하는부서임. 동부서는연구용의약품의안전성과모든연구의수행이 GCP에부합하는지감시하는업무도담당함. 뿐만아니라자발적인말레이시아 GLP 프로그램에의거하여의약성분의비임상안전성검사를수행하는검사시설에대한 GLP 인증서도발행함 - 홈페이지 : npra.moh.gov.my < 그림 3. NPRA 조직도 > * 출처 : National Pharmaceutical Regulatory Agency Malaysia( index.php/about-npcb/npcb-info/organisational-chart) 6

10 4) 말레이시아약물유해반응검토위원회 (MADRAC, Malaysian Adverse Drug Reaction Advisory Committee) - 말레이시아약물유해반응자문위원회로서, 규제과정의일환으로약물유해반응의감시를통하여등록의약품을소비하는국민의안전을보장하기위한제도가설립되었음 - 말레이시아국내에서사용하기위해등록되는의약품의안전성프로필감시업무를수행하기위하여 DCA 산하에설립되었음 - 국내 외에서발생하는의약품안전성문제에대한정보를 DCA에제공하고있음 - MADRAC의사무국인국립의약품안전성감시센터는 1990년세계의약품안전성감시프로그램의 30번째회원기관으로인정을받음 - 감시프로그램에따라 MADRAC가접수및심사하는전체약물유해반응보고서는 WHO 데이터베이스에포함되기위해스웨덴에소재하는 Uppsala 감시센터에제출됨 (2) 인허가규제정보 1) 시판허가 - 말레이시아에서의약품을시판하려면국립의약품관리국 (NPRA) 에반드시등록해야함. 의약품의품질과안전성및유효성과관련하여 DCA가부과하는모든규제요건을충족하는경우에만등록할수있음 - 신청인은의약품평가방식을판단하기위해의약품의분류를숙지해야함. 의약품분류가불확실한경우, 신청인은분류확인을위해 NPRA, 제품등록센터, 규제공조과에분류양식을제출할수있음 - 시판허가를위해제출된서류평가는 DCA 규정에따라결정되며, 결정된사항은제품등록소유자에게이메일 / 공식적인서문을통해발송됨. 따라서제품등록소유자는당국에의해공지받은후, 제품등록번호 (MAL number) 를부여받게됨 - 의약품등록은 5년간유효하며, 의약품등록갱신은유효기간이만료되기 6개월전에이루어져야함 가. 등록 ( 허가 ) 조건 - 말레이시아의약품허가는 QUEST 3+ 라는인터넷시스템을통해서만이루어지며, 7

11 QUEST 3+ 에접속하기위해서비밀번호는이메일로통보및 USB 형식의디지털인증서는우편으로배송됨 * 국립의약품관리국 (NPRA) 사이트 ( 에서 QUEST 3+ 시스템접속 ( - 의약품등록신청은말레이시아내의사업장주소를가진말레이시아현지기업만가능하며, 의약품소유사업자 ( 기업 ) 가아닌자가의약품등록을하기위해서는의약품소유사업자 ( 기업 ) 에서문서로의약품승인관련권한을받아야하며, 이문서를승인공문 (Letter of Authorization) 이라고함 - 의약품등록절차는전체평가 (Full Evaluation) 와약식평가 (Abridged Evaluation) 로구분되며, 전체평가는근무일기준약 8개월이소요되고, 약식평가는근무일기준 2~3개월이소요됨 - 전체평가대상의약품은처방의약품 (Prescription Drug), 신규화학물질 (NCE) 이고, 약식평가대상의약품은비처방의약품 (Non-Prescription Drug), 건강보조제 (Health Supplement Product), 화장품 (Cosmetic Product) 등임 나. 심사절차 - 신청서는우선심사절차에해당하는의약품의경우를제외하면접수순서대로처리 - 1 단계 : QUEST 3+ 시스템으로접수 - 2 단계 : 1차선별과적합성평가 (25~40일소요 ) 후수수료납부 - 3 단계 : 심사 (3~6개월소요 ), 보완발생시 6개월이내자료제출, 미제출시무효처리됨 - 4 단계 : 승인 다. 수수료 - 등록을위해서는 QUEST 3+ 시스템의회원등록및 USB 토큰을구입한후에등록업무를시작할수있음 - 등록수수료는표 3과같으며, 수수료는환급되지않으며외화는수납하지않음 - DCA는의약품등록이전에수행되는실험실연구 / 시험에서발생하는비용을신청인에게청구하며, 모든등록신청은수수료를동봉해야함 8

12 표 1. 의약품범주에따른평가기간분류 평가방법 소요기간 신약 전체평가 245 근무일 생물의약품 전체평가 245 근무일 제네릭의약품 ( 예정독물 ) 전체평가 210 근무일 제네릭의약품 ( 예정외독물 ) : 약식평가에해당하지않는모든제네릭의약품제네릭의약품 ( 예정외독물 ) : - Antiseptics/skin disinfectants - Locally-acting lozenges/pastilles - Topical analgesic/ counter-irritants - Topical nasal decongestants - Emollient/ demulcent/ skin protectants - Keratolytics - Anti-dandruff - Oral care - Anti-acne - Medicated plasters/ patch/ pad - Topical antibacterial 전체평가 약식평가 210 근무일 80 근무일 * 출처 : 2014 년의약품해외시장진출을위한인허가및시장정보 Ⅰ, 한국보건산업진흥원 표 2. QUEST 회원 USB 토큰요금 신청분류최초사용자추가사용자 USB 토큰갱신 요금패키지 A(2년유효 USB 토큰 + 안내매뉴얼 ) : RM 335 패키지 B(1년유효 USB 토큰 + 안내매뉴얼 ) : RM 320 패키지 A(2년유효 USB 토큰 + 안내매뉴얼 ) : RM 335 패키지 B(1년유효 USB 토큰 + 안내매뉴얼 ) : RM 320 패키지 C1(2년유효신규 USB 토큰 ) : RM 280 패키지 C2(1년유효기존 USB 토큰 ) : RM 100 * 출처 : 2014 년의약품해외시장진출을위한인허가및시장정보 Ⅰ, 한국보건산업진흥원 9

13 표 3. 수수료 분류처리료 (MYR) 분석료 (MYR) 합계 (MYR) a) 신약 b) 생물의약품 a) 제네릭의약품 ( 예정독물 ) b) 제네릭의약품 ( 예정외독물 ) c) 건강보조제 1,000 1,000 단일원료의약품 : 3,000 4,000 원료의약품 2종이상 : 4,000 5,000 단일원료의약품 : 1,200 2,200 원료의약품 2종이상 : 2,000 3,000 전통의약품 ,200 * 출처 : 2014 년의약품해외시장진출을위한인허가및시장정보 Ⅰ, 한국보건산업진흥원 2) 신청서 - 수수료납부를위해서는완전한서류만인정및승인됨. 심사과정에서신청서가미비한것으로확인될경우, 신청서는기각되며시스템을통해신청인에게이를통보함 - 지침 : 의약품등록안내문서는신청절차에대해명확한지침을제공함. 본지침은 1952년의약품판매법 ( 법률 368호 ) 과 1989년개정본, 1984년의약품및화장품규제규정의법적요건을토대로함. 뿐만아니라 ASEAN 요건에대해서는 ACTD ASEAN 공통기술서류 (ACTR) 및 ACTR ASEAN 공통기술요건 (ACTD) 을참조함 - 문서와자료는국립의약품관리국 (NPRA) 에제출하고영어나말레이시아어로작성해야함. 영어나말레이시아어가아닌자료제출을원하는신청인은공증을거친영어나말레이시아번역본을제출해야함 - 의약품등록신청서는아래형식을취할수있음 신약 ( 신형화학물과방사성의약품, 신형병용의약품을함유하는의약품 ) 생물의약품 ( 백신과혈액제제, 단클론항체, 재조합단백질 ) 제네릭의약품 - 위에기재된의약품을제외한 OTC는전체평가를받음. 피규제독물을함유하는의약품은약식평가절차를받을수없음 10

14 - 신청서양식 말레이시아당국은 ASEAN CTD(ACTD) 를인정함. ICH CTD는인정하지않으므로 ICH CTD를 ASEAN CTD 양식으로변경해야함 전체제출물은 NPRA QUEST 3+ 시스템 ( front-end/login.php) 을통해온라인으로제출해야함 - 신규화학물질 (NCE) 및생물의약품에대해서는현재심사과정을단축하기위해온라인시스템에제출된것과마찬가지로발표된임상서류 (5 세트 ) 와 Ⅱ, Ⅲ, Ⅳ부문서 ( 각 1세트 ) 를제출해야함 - 제네릭의약품을비롯한모든의약품형식에대해서는심사를단축하기위해온라인양식을통해제출되는분석증서, P5.2 - 분석절차와 P5.3 - 분석절차검증을하드카피 (1 세트 ) 로복사및제출해야함 < 그림 4. ACTD> * 출처 : 2014 년의약품해외시장진출을위한인허가및시장정보 Ⅰ, 한국보건산업진흥원 11

15 < 그림 5. 의약품등록절차 > * 출처 : Malaysia Regulatory System for Pharmaceutical Products 12

16 3. 건강보험및약가제도 (1) 보건의료체계 - 말레이시아의료제도는공공부문과민간부문으로이원화되어있음 - 약 70% 의의료서비스는정부지원금으로운영되는공공의료체계를통해제공되며, 약 30% 의민간의료서비스는철저히진료수익을통해운영되며치료와재활서비스를모두제공 - 공공의료서비스는정부가대부분부담하며주로근로소득세를통해충당하고그이외기타의료서비스재정의출처는자발적인사보험과사회보장, 본인부담금으로부터충당 - 말레이시아는의무보험제도나국민건강보험제도가시행되지않기때문에자발적사보험의가입이늘어나는경향이있으며, 국가의료지출은 GDP의 8% 에불과함 (2009년) < 그림 6. 보건의료서비스체계 > * 출처 : 2014 년의약품해외시장진출을위한인허가및시장정보 Ⅰ, 한국보건산업진흥원 13

17 1) 공공의료 - 보건부, 교육부, 국방부가말레이시아의공공의료공급자임 - 보건부는말레이시아의주요공공의료공급자로서외래환자의치료간호에서부터예방과건강증진에이르기까지의료서비스를담당 - 교육부는학문과의료연구를위해국내에최소 3개의대학병원을운영 - 국방부는군인과그가족에게치료를제공하기위해몇개의군병원을소유하고있음 2) 민간의료 - 민간병원은 1971년발효된민간의료원법에의해허가된기관들이며, 동법에서는민간병원을최소 1개이상의병상을갖춘민간시설로규정 - 40년전부터시작된민간의료는매우상업화되었으며, 수익을기반으로하여말레이시아부유층에의한혜택을받고있음 - 그러나정부는민간의료서비스체계의질을보장하기위해 1998년민간의료시설서비스법 (Private Healthcare Facilities and Services Act) 을통해민간의료서비스를효과적으로모니터링하고있음 (2) 의료보험 - 공공보험에대한기존의낮은가입률과의료비용상승은민간보험기업들을위한거대한시장을창출할것으로기대되며, 이를활용하기위해말레이시아에서는주요민간의료서비스공급자와연계해다양한보험사가활동중이며이들은국내환자의많은수요에적합한다양한형태의패키지를제공하고있음 - 과거영국과미국회사들이독점을누리고보험산업을장악했으며, 동시에국내회사들도보험계약을판매하기시작함. 또한정부지원정책을통해국내회사에게투자와시장점유율을늘릴것을설득했으나적절한보장없이일부회사가파산하였음. 보험업무를다시체계적으로만들기위해말레이시아정부는 1963년보험법 (Insurance Act) 을도입함 - 현재 9개의타카풀 (Takaful : 이슬람법에따른브랜드보험 ) 과 16개의생명보험사가말레이시아에서활동하고있으며, 말레이시아에는일반적으로보험가입자를위해 2가지유형의의료보험이존재함 건강관리조직 (Health Maintenance Organization) 이라고종종부르는관리 14

18 의료 (Managed Care) 와손해보상 (Indemnity) (3) 약가 1) 담당부서 - 약가관리사업단 (Medicine Price Unit) 보건부내의약서비스국 (Pharmaceutical Services Division) 소속 역할 : 의약품가격이면밀히감시되고규제되는다른국가와달리말레이시아정부는공중보건부문에공급되는약가만감시하며민간의료부문에서는시장의힘에따라약가가결정됨 - 의약조달사업단 (Pharmaceutical Procurement Unit) 보건부내의약서비스국 (Pharmaceutical Services Division) 소속 역할 : 정부조달과입찰자활동의공조를담당 2) 가격정책 - 말레이시아국가의약품정책 (MNMP, Malaysian National Medicines Policy) MNMP는가격정책뿐아니라 약가적정비용 에국가재정조달정책을포함 2009년 MNMP에대한중기검토워크숍이진행되었으며, 보다명확한실행계획이입안됨 3) 약가결정 - 공공부문 필수의약품목록 (1983년이후시행 ) 에대한가격은주요도매업자인 Pharmaniaga Logistics Sdn Bhd( 종전 Remedi Pharmaceuticals) 와의협상이후보건부에서결정 * Pharmaniaga Logistics Sdn Bhd : 국내대표제약회사 Pharmaniaga의자회사로, 공립의료기관이구입하는의약품의약 75% 를차지 엄격한정책을시행한결과공공약가는시장가격이하로책정되며, 이는정부가수가의약 60% 를담당한다는점을감안할때필요한조치임 제조품질과의약품의효능, 최저가를고려하여나머지정부조달은공개입찰방식으로진행됨 15

19 - 민간부문 이론상자유가격이지만, 정부는민간기업과거래할때보건부의약품목록에있는가격을지침으로사용하는추세임 민간부문가격규제를위한전체제안은아직입안되지않음 의약품에대한본인부담금은총액의약 25% 로사보험이약 15% 를부담함 * New Strait Times 보고에따르면국민의약 15% 는사보험에가입 (4) 의료시설현황 - 말레이시아에는 2009년기준 334개의병원이있으며, 그중공공병원이 133개, 민간병원이 201개임 - 민간병원의경우지난 10여년간빠르게성장하여말레이시아전체병원의 60% 를차지하고있음 - 병원수기준으로는민간병원이전체의 60% 를차지하나, 여전히의료서비스는공공병원이압도적으로주도하고있음 ( 보건부가가장큰의료서비스제공주체임 ) 표 4. 의료기관구분 1 차의료기관 ( 전문진료과목 없음 ) 1 차의료기관 ( 전문단일 진료과목없음 ) 2 차의료기관 3 차의료기관합계 * 출처 : 한국의료해외진출가이드, 말레이시아, 한국보건산업진흥원, 2009 년기준 16

20 4. 시장정보 (1) 경제동향 1) 국내총생산 (GDP, Gross Domestic Product) 표 5. GDP 현황 GDP(10억달러 ) 인당 GDP( 달러 ) 10,653 10,809 11,050 * 출처 : &scsm=1&ssd=1&sort=country&ds=.&br=1&c=548&s=NGDPD%2CNGDPDPC&grp=0&a =&pr.x=57&pr.y=13, World Economic Outlook Database April 2016, IMF 2) 보건의료비 - 말레이시아의보건의료비지출은 GDP의 5% 미만이나주변국들에비해서는높은편이며, 보건의료의공공지출이이같은의료비지출에기여하고있음 - 출산율증가와사망률감소로말레이시아인구증가 2013년통계청발표에의하면, 65세이상인구는 2013년 5.5% 에서 2020년 7.0% 로연평균성장률 (CAGR) 4.2% 의증가가예상됨 기대수명의연장에따른노인인구의증가추세로노인인구에대한재정지원이강화됨 노인인구의증가와관련질병부담으로말레이시아정부는고령자치료에할당하는재원을늘려야할것이며, 이는의료시장성장동인으로알려짐 표 6. 보건지표 보건지표 % GDP 대비보건의료총지출 4.0 전체의료비지출중정부지출분담률 55.0 전체의료비지출중민간지출분담률 44.9 개인지출의료비중본인부담률 77.5 * 출처 : 2014 년의약품해외시장진출을위한인허가및시장정보 Ⅰ, 한국보건산업진흥원 17

21 (2) 산업동향 1) 제약시장현황 - 말레이시아는대부분수입의약품중브랜드의약품수요가약 75% 임 - 과도한수입의약품에대한의존도, 의약품에대한판매세면제는국내다국적제약회사에상당한상업적기회를조성함 - 정부가공립병원에무료로의약품을제공하거나보조금을지급하지만의약품이부족하거나공립병원의대기시간이길어환자대부분은민영약국이나조제전문의로부터고가의의약품을구입함 - 말레이시아의제네릭시장은 2005년부터 2010년급속히확대됨 2005년 MYR 6억 2,500만 2010년 MYR 11억 2,600만 (CAGR 12.5%) 2) 제약시장전망 - 노령인구증가, 관련질환발생에따른치료비증가, 의료관광증가, 비교적쉬운인허가규제, 약가규제의부재등으로제약시장전망이밝은것으로알려져있음 년보건부에따르면, 제약시장의규모가 2008년 12억달러에서 2020년 37억달러 (CAGR 9.5%) 가될것으로예상됨 - 다수의브랜드의약품이향후 10년안에특허가만료됨에따라전세계적으로중요한제네릭시장으로떠오를것으로예상되고있음 18

22 3) 주요제약기업 표 7. 주요제약기업 회사명특징주요사항 - 보건의료분야전문가확보 - 광범위한지역을커버 - Value chain 별포괄적인서비스제공 - 네트워크형성이잘된다양한제품을생산 - 국가 / 시장과직접적인계약이가능한웹사이트구축 - 광범위한지역을커버 년설립 - 지사 : 8개 - 직원수 : 350명 - 주요의약품 : 60개 - 병원, 개인클리닉, 의사, 약국, 판매체인점등 10,000명고객확보 - 주요의약품 : 56개 - 지사 : 16개 - 파트너사 Baxter Oncology 의료기기포트폴리오 년설립 - 주요의약품 : 40 개 - 수많은틈새시장공략 - 지사 : 6 개 - 소수 Principal 과집중포트 폴리오 - Principal 과의긴밀하고 장기적인관계를중요시함 * 출처 : 2014 년의약품해외시장진출을위한인허가및시장정보 Ⅰ, 한국보건산업진흥원 (3) 국내제약사진출현황 - 녹십자, 대웅제약, 유유제약등 19

23 5. 업체정보 (1) 제약협회 1) 국내제조업체 : PhAMA(Pharmaceutical Association of Malaysia) - 주소 : C-18-2, Block C Seri Tegamas 32 Square(3 Two Square), Jalan 19/1, Petaling Jaya, Malaysia - 전화 : (3) - 홈페이지 : phama@phama.org.my 2) 제약산업기구 : MOPI(Malaysian Organisation of Pharmaceutical Industries) - 주소 : Global Business & Convention Centre Mezzanine Floor, Block A, No. 8, Jalan 19/1, Section 19, Petaling Jaya Selangor Darul Ehsan, Malaysia - 전화 : 홈페이지 : (2) 무역관 1) 쿠알라룸푸르무역관연락처 - 주소 : 9th Floor, Menara Hap Seng(Formerly known as Mui Plaza), Jalan P. Ramlee, Kuala Lumpur, Malaysia - 전화 : 홈페이지 : bokkotra@kotra.or.kr (3) 대사관 - 주소 : No. 9 & 11, Jalan Nipah, Off Jalan Ampang, Kuala Lumpur, Malaysia - 전화 : 홈페이지 : mys.mofa.go.kr - korem-my@mofa.go.kr 20

24 (4) 파트너사리스트 번호회사명제조사 CSO CRO 컨설팅 1 Hovid V 2 CCM Duopharma Biotech Berhad (CCMD) V 3 Kotra Pharma V 4 SUN PHARMA V 5 Upha Corporation V 6 Clini-Foods V 7 Pharmanniaga V 8 ABio Marketing V 9 Antah HealthCare Group V 10 Ards Marketing V 11 DKSH V 12 Healol Pharmaceuticals V 13 Intelius V 14 Saehar Pharmaceutical V 15 Venture Aron V 16 Zuellig Pharma V 17 Info Kinetics V 18 Veras Research V 19 PPD V V 20 Alpha Biologic 21 Inno Bio 21

25 (5) 파트너사상세정보 * 출처 : 등 회사명 주소 웹사이트 Hovid 121, Jalan Tunku Abdul Rahman, Ipoh, Perak Contact point 이름 info@hovid.com 전화번호 설립일 직원수 업종 R&D 제조유통 CRO CMO 컨설팅기타 비고 Hovid(formerly known as Ho Yan Hor) carries with her years of invaluable experience in the pharmaceutical industry. Dating back to early 1940s, when the business was first established, Hovid's only commodity was Ho Yan Hor Herbal Tea, concocted by its founder, Dr Ho Kai Cheong. With the intention of helping people, Dr Ho Kai Cheong formulated a unique concoction of 24 specially chosen herbs and developed Ho Yan Hor Herbal Tea. It was a popular alternative to western medicine during post World War Ⅱ with its Cooling and Anti Viral properties. Ho Yan Hor Herbal Tea was the most seek after solution during the Worldwide Flu Epidemic in 1950s. Since then, Ho Yan Hor has become a household name. After 74 years, Ho Yan Hor Herbal Tea still remains as the favorite among many as a natural herbal beverage. In the 1980s, along with his father's success, David Ho, as a well trained pharmacist, led Hovid into a new chapter of manufacturing excellence. Armed with expertise in pharmacy with strong passion of entrepreneurship, David ventured into mainstream medical approaches. From that point on, Hovid grew to become one of the Malaysia's leading pharmaceutical manufacturers of high quality and innovative medicinal preparations and health supplements with more than 400 products distributed over 50 countries globally. 22

26 회사명 주소 웹사이트 CCM Duopharma Biotech Berhad(CCMD) Lot 2599 Jalan Seruling 59 Kawasan 3, Taman Klang Jaya Klang, Selangor Darul Ehsan duopharma.com.my 이름 Contact point 전화번호 설립일 직원수 업종 R&D 제조유통 CRO CMO 컨설팅기타 비고 CCM Duopharma Biotech Berhad(CCMD) is the leading Malaysian pharmaceutical manufacturer and a key regional player that develops, manufactures and markets generic and Over-The-Counter pharmaceutical products. Our portfolio of products supports wellness for every stage of life from prevention to treatment and cure. We produce over 200 generic drugs, including our award winning medications such as Omesec and Vascor whilst our Over-The-Counter brands such as CHAMPS, Flavettes, Proviton and Naturalle are well recognised and accepted by consumers in Malaysia and regionally. Following the integration of six of our parent company's pharmaceutical units into CCMD's fold, we are today leveraging on an enhanced manufacturing capacity to bolster our product offering to reap the benefits of emerging patent cliffs and increase our revenue base as more generic drugs become available for manufacture. Going forward, we will focus our efforts on expanding into specialty drugs and biopharmaceuticals, in niche therapeutic areas as well as expanding our footprint in the ASEAN region. 23

27 회사명 주소 웹사이트 Kotra Pharma Kotra Pharma(M) Sdn Bhd(90082-V) 1, 2 & 3, Jalan TTC 12, Cheng Industrial Estate, Melaka 이름 Contact point 전화번호 설립일 1982 직원수업종 R&D 제조유통 CRO CMO 컨설팅기타 Founded in 1982, Kotra Pharma s singular aim has always been to promote better health for individuals in all stages of life. Today, we remain devoted to providing excellent nutraceutical and pharmaceutical products and growing to meet an increasingly diverse range of healthcare needs. At Kotra Pharma, we believe that everyone deserves a healthier tomorrow. That s why at Kotra Pharma, we believe that every individual has the right to excellent and accessible healthcare. With the goal of enhancing holistic well-being for every stage of life we are committed to applying cutting edge pharmaceutical research in our extensive portfolio of products. For over 27 years, Kotra Pharma has earned a rightful place in the pharmaceutical industry and in the homes of thousands of 비고 families, based on genuine trust in our products. This is true for healthcare professionals, patients and consumers. We seek to continuously expand the horizons of good health and are committed to providing products aimed at healing as well as preventing illnesses from infants to seniors. Kotra Pharma range of nutraceutical and pharmaceutical products address holistic wellness through every phase of life - from pre-natal healthcare for mother and baby to golden year-wellness. With an extensive range of therapeutic products, Kotra Pharma provides remedies for a variety of diseases. However, a healthy lifestyle is not just a matter of treating diseases as they arise. Hence, we are especially devoted in the prevention of illnesses through our preventive healthcare line of vitamins, supplements and vaccinations. 24

28 회사명 주소 웹사이트 SUN PHARMA Malaysia[RANBAXY(MALAYSIA) SDN. BHD.] Peti #8, 5th Floor, South Block, Wisma Selangor Dredging, 142-A, Jalan Ampang, Kuala Lumpur Contact point 이름 전화번호 설립일 1961 직원수업종 R&D 제조 유통 CRO CMO 컨설팅 기타 비고 In Malaysia, we are ranked amongst the Top 10 pharmaceutical companies. We have a strong sales and marketing team and enjoy significant brand recognition amongst doctors, hospitals and in the retail pharmacies. We have a manufacturing unit in Sungai Petani, Kedah. This unit manufactures Oral Dosage Forms(tablets, capsules, dry syrups) and has the approval of the Ministry of Health. It has an independent Quality Unit to ensure the safety, identity, strength, purity and quality of the products. The unit also has a Technology Development Laboratory equipped with linear scale smaller capacity manufacturing equipment to consistently deliver products with the intended quality attributes. We were adjudged the Malaysian Pharmaceutical Company of the Year in the Generics Drug Category in 2012 by Frost & Sullivan. 25

29 회사명 주소 웹사이트 Upha Corporation Lot 2&4 Jalan P/7 Section 13, Bangi Industrial Estate Bandar Baru Bangi Selangor 이름 LIM Chuang Yik Contact point 전화번호 설립일 1976 직원수업종 R&D 제조 유통 CRO CMO 컨설팅 기타 비고 The Upha group of companies, with its strong R&D background, multinational heritage and local entrepreneurship, is one of Malaysia's premier pharmaceutical companies. Upha's core business centers around the manufacture and sale of generic drugs and consumer products such as health and food supplements. Upha is best known for its wide range of generic drugs which offer high quality and efficacy at competitive values. We manufacture over 250 generic drugs, many of which are well established and leading generic brands ; our forte being sustained release and controlled release formulations. Upha also manufacture over 80 health and food supplements including vitamins and herbal products. The proud owner of many leading local and regional brands, we will continue to introduce innovative branded products. Upha is currently looking for a potential partner to help in the following : - Register selected products with the relevant authorities(be it the Health or Food Agencies) - Handle exclusive distribution of the products registered - Identify further products for registration to grow the business 26

30 회사명 주소 웹사이트 Clini-Foods Sdn Bhd 1572, Jala Besar Valdor, Seberang Perai Selatan, Sungai Bakap Penang clini--foods-sdn-bhd1.business1.com 이름 Ying Hooi Liew Contact point 전화번호 설립일 1986 직원수업종 R&D 제조 유통 CRO CMO 컨설팅 기타 비고 Clini-Foods is a cgmp compliant pharmaceutical manufacturer with over 20 years of experience in manufacturing of pharmaceutical dosage forms for human consumption. Our plant is capable of producing pharmaceuticals in liquid, tablet, capsules, lotion, cream, ointment, powder, granules etc for various indications. Clini-Foods is a generic pharmaceutical manufacturer and distributor in Malaysia. Clini-Foods is experienced in contract manufacturing services, providing professional manufacturing services to other pharmaceutical manufacturers and clients. Our products are distributed both in our local market and exported to Singapore, Hong Kong, African countries, Middle East Countries and South America. We undertake contract manufacturing projects both for our local and foreign customers. We also import finished pharmaceuticals from other manufacturers for distribution and marketing in Malaysia. We are always on the look out for good quality generic pharmaceuticals with proven efficacy through comparative bioequivalent studies against the originator products. 27

31 회사명 주소 웹사이트 Pharmanniaga No. 7, Lorong Keluli 1B, Kawasan Perindustrian Bukit Raja Selatan, Seksyen 7, Shah Alam, Selangor Darul Ehsan Contact point 이름 전화번호 설립일 1980 직원수업종 R&D 제조 유통 CRO CMO 컨설팅 기타 비고 As Malaysia s largest listed integrated pharmaceutical group, Pharmaniaga Berhad has blazed a trail within the healthcare industry as a provider of quality products and services. Listed on the Main Board of Bursa Malaysia and having established itself as a leader in the local market, Pharmaniaga also has a growing global presence. As part of our drive to become a total integrated healthcare solutions provider, our core businesses span across a wide spectrum of the industry. This includes logistics and distribution, manufacturing of generic pharmaceuticals, sales and marketing, as well as distribution of medical products and hospital equipment. Drawing upon the synergies of these activities, Pharmaniaga has expanded its reach to Malaysians through the establishment of community pharmacy. The heart of our corporate philosophy is driven by our motto, Passion for Patients. Above all, we emphasis on delivering our promises to our clients with the highest standards of excellence, as we seek to create a lasting legacy of doing business with a conscience. 28

32 회사명 ABio Marketing Sdn Bhd 주소 No. 2 Jln SS 13/5 Subang Jaya, Selangor 웹사이트 이름 Wong Ching Loon, Kel Contact point 전화번호 설립일 1962 직원수업종 R&D 제조 유통 CRO CMO 컨설팅 기타 비고 ABio Marketing Sdn Bhd is the marketing arm of Apex Pharmacy Marketing Sdn Bhd and operates as a distributor of pharmaceutical products such as antiseptic powder and medical disposables. The company was founded in 1962 and is based in Subang Jaya, Malaysia. ABio Marketing Sdn. Bhd. operates as a subsidiary of Apex Healthcare Berhad. ABio own sister companies in Indonesia, Singapore and China to distirbute pharmaceutical products. ABio is looking for partners which could co-operate to expand the business network to other countries/region. 29

33 회사명 주소 웹사이트 Antah HealthCare Group No. 3 Jalan 19/1, Petaling Jaya, Selangor Darul Ehsan Contact point 이름 enquiry@ahcg.com.my 전화번호 설립일 직원수 250 업종 R&D 제조유통 CRO CMO 컨설팅기타 비고 Antah HealthCare Group is proud to remain as one of the largest Malaysian owned healthcare marketing and distribution company in the country, having over 250 employees with branch offices located at major cities nationwide. The group has over 50 years of experience in the healthcare industry and is supported by various market leaders of their own expertise - from highly specialized operating theater equipment to delicate patient monitoring devices, and a wide range of premier pharmaceutical products as well as revolutionary cell and cancer therapies. The company has also collaborated and embarked into the commercialization and supply of various non-medical equipment and products that are niche and revolutionary in nature. The group expanded its' operations in 2012 by establishing an assembly plant for the local manufacture of a range of medical equipment for the Malaysian market. One of the company's strength is its team of experienced and professional sales personnel, which covers the target market areas besides providing innovative marketing strategies, concise instantaneous management reports and conducting regular customer market surveys for its valued principals. The highly proficient administrative and dedicated support personnel enables the group of companies the capability to provide efficient and prompt on-line order processing and reliable delivery service to its valued customers throughout the country. 30

34 회사명 주소 Ards Marketing Sdn Bhd 121-1, Jalan Sultan Abdul Samad, Brickfields, Kuala Lumpur 웹사이트 이름 Saravanan Subramaniam Contact point 전화번호 설립일 직원수 업종 R&D 제조유통 CRO CMO 컨설팅기타 비고 Company registered with Health Ministry Malaysia to import, distribute and market pharmaceutical products in Malaysia and Singapore. Have just registered with Indonesia and Philippines. Value addition of product with successful registration certification from Drug Control Authority Malaysia. Re-packing facilities complete with graphics designing studio and printing unit. 31

35 회사명 주소 웹사이트 DKSH Malaysia B-11-01, The Ascent, Paradigm, No. 1, Jalan SS 7/ 26A, Kelana Jaya, Petaling Jaya Selangor dksh.com/cs/dksh_my/en/home 이름 Contact point 전화번호 설립일 직원수 업종 R&D 제조유통 CRO CMO 컨설팅기타 비고 We are the leading Market Expansion Services provider for companies who want to grow their business in Malaysia. Serving our business partners through our extensive global networks and industry expertise, as well as our profound local knowledge of the markets in Malaysia, we help companies to grow their businesses in new and existing markets. Serving our business partners through our extensive global networks and industry expertise, as well as our profound local knowledge of the markets in Malaysia, we help companies to grow their businesses in new and existing markets. We provide our partners with sound expertise, on-the-ground logistics and tailor-made services based on a comprehensive network of unique size and depth. DKSH Malaysia provides : - Full distribution services to small and medium-sized companies, who would normally outsource all aspects of their business except manufacturing - Bespoke, tailor-made solutions to large and some medium-sized companies, such as Logistics, Sales and product management of non-core brands, Sales for selective channels, Sales for some geographical areas 32

36 회사명 주소 웹사이트 Healol Pharmaceuticals Sdn Bhd 74-3, Jalan Wangsa Delima 6, KLSC Wangsa Maju, Kuala Lumpur Contact point 이름 Pruthvi Karn 전화번호 (7) 설립일 1997 직원수업종 R&D 제조 유통 CRO CMO 컨설팅 기타 비고 Healol is a pharmaceutical marketing and distribution company that registers, warehouses, markets and distributes pharmaceuticals products of well-known selected companies from around the world. Our customers are Doctors, Clinics, Hospitals and Pharmacies. We have a local presence in each of our markets of operation which now include Malaysia, Vietnam, Philippines, Thailand and Cambodia. Our intimate knowledge of the markets we operate in give us the edge in doing what we do best, which is building brands. Healol started its operations in Malaysia in the year 1997 with just 6 registered products. In a short span of 11 years, Healol has over 150 quality products of reputed manufacturers that are being marketed in the entire Peninsular of Malaysia as well as East Malaysia. With a dedicated team of 38 medical representatives, 4 field managers, 2 Sales Managers & over 20 support staff, Healol provides professional registration, import, warehousing, distribution and marketing services to our principals. As a distributor and marketer of pharmaceutical products, Healol is committed to provide quality services which meet the customer needs. 33

37 회사명 주소 웹사이트 Intelius Plot 11, Lorong Bemban 2 Estet Perindustrian Bemban, Batu Gajah intelsius.com Contact point 이름 compliance@intelsius.com 전화번호 설립일 1998 직원수업종 R&D 제조 유통 CRO CMO 컨설팅 기타 비고 Intelsius is a forward-thinking company that offers a comprehensive and innovative range of temperature controlled packaging solutions to meet the unique and demanding challenges of the global cold chain and life sciences industry. We pride ourselves in creating intelligent packaging that is environmentally sustainable and regulatory compliant. Patient safety is always at the forefront of our product development and ensuring our customers products and samples arrive at their destination with their integrity intact is paramount. 34

38 회사명 Saehar Pharmaceutical Ltd. 주소 Lot 1, Persiaran Batu Nilam Klang, Selangor 웹사이트 이름 Merle Saehar Contact point 전화번호 설립일 2001 직원수업종 R&D 제조 유통 CRO CMO 컨설팅 기타 비고 Saehar was established in Though still relatively new as a company, our individuals have had experience in the business of more than 5 years. Saehar is looking for finished pharmaceuticals products and cosmetics. Customers include internet pharmacies, independent pharmacists and individuals. In an effort to obtain the best prices possible for our clients, we are constantly looking for manufacturers who are able to supply finished pharmaceuticals at competitive prices. 35

39 회사명 주소 Venture Aron Sdn Bhd Wisma Yoon Cheng Unit A-2-1 & 2, No. 718 Batu 4 1/2, Jalan Ipoh, Kuala Lumpur 웹사이트 이름 Henry Cooper Contact point 전화번호 설립일 2002 직원수업종 R&D 제조 유통 CRO CMO 컨설팅 기타 비고 Venture Aron Sdn Bhd supplies pharmaceutical, bulk drugs, medicines & raw materials, bulk drugs, medicines & raw materials finished injectables, tablets, capsules and oral preparations, medical, surgical & hospital instruments & equipment, men health products, pharmaceutical, bulk drugs, medicines & raw materials. 36

40 회사명 주소 웹사이트 Zuellig Pharma Malaysia 15 Persiaran Pasak Bumi, Seksyen U8 Perindustrian Bukit Jelutong, Shah Alam Selangor Darul Ehsan 이름 Contact point 전화번호 설립일 1922 직원수업종 R&D 제조 유통 CRO CMO 컨설팅 기타 비고 Zuellig Pharma has been successfully serving the Asian healthcare market since During this time our network has expanded to cover the needs of 12 countries across the region. Our reputation for best in class global conduct and service excellence has remained our foundation, supporting us and our clients throughout the years. As an integral part in the development and enhancement of healthcare in Asia for almost a century, we support the business requirements of our clients, accepting both compliance and financial risk on their behalf - a service which is unique to our company and in this region. With Zuellig Pharma by your side, you are able to navigate complex distribution channels and find new areas to expand. Our comprehensive set of healthcare solutions covers clinical reach, commercial, distribution, community pharmacies, as well as payor and patient solutions. Our focus has always been to support the rapid and sustained growth of our clients. We expand access to new channels and connect healthcare stakeholders, helping our clients realize their full potential in Asia. Zuellig Pharma is committed to making healthcare more accessible. 37

41 회사명 주소 웹사이트 Info Kinetics Gleneagles Penang, 5th Floor, 1 Jalan Pangkor, Penang info-kinetics.com Contact point 이름 admin@info-kinetics.com 전화번호 설립일 직원수 업종 R&D 제조유통 CRO CMO 컨설팅기타 비고 Info Kinetics aims to make your Clinical Outsourcing & Contract Research better, greater and faster. Info Kinetics understands what it takes to achieve better outcomes ; by a delicate balance of science & business factors. With drug development costs ever increasing, Info Kinetics pushes hard for greater efficiency in all their processes. We are looking at the same goals like you - Faster to Market! Info Kinetics is set up primarily to serve pharmaceutical companies in planning and conducting pharmacokinetic and clinical trials as well as to provide independent analytical services as part of their drug development program. Info Kinetics offers services that encompass all stages of drug development, from Phase Ⅰ to Ⅲ clinical trials. This includes bioequivalence and bioavailability studies. The company has a track record for rapid trial subject recruitment which provides efficient and effective trial coordination in this region. Our services are proven to be cost-effective as a result of improved trial coordination. Info Kinetics is approved as a Research & Development company by the Malaysia Industrial Development Authority(MIDA). 38

42 회사명 주소 웹사이트 Veras Research Metropolitan Square W103A, Jalan PJU8/1 Damansara Perdana, Petaling Jaya Selangor Contact point 이름 전화번호 설립일 직원수 업종 R&D 제조유통 CRO CMO 컨설팅기타 비고 Veras Research is a sister company of Azmi Burhani Consulting focussing on services for clinical trials. Our GCP certified clinical trial team has experience in conducting clinical research and trials and has worked with the Clinical Research Centre and Ministry of Health Malaysia on several projects. As a Contract Research Organization, Veras Research is well equipped to expand to become a major player in Malaysia and south-east Asia through key projects and strategic partnerships. Veras Research offers a full range of services for multinational trials and local pharmaceutical firms to conduct clinical trials as well as research studies. 39

43 회사명 주소 웹사이트 PPD Malaysia Level 8, Pavilion KL 168, Jalan Bukit Bintang, Kuala Lumpur 이름 Contact point 전화번호 설립일 직원수 업종 R&D 제조유통 CRO CMO 컨설팅기타 비고 PPD is a leading global contract research organization providing comprehensive, integrated drug development, laboratory and lifecycle management services. Our clients and partners include pharmaceutical, biotechnology, medical device, academic and government organizations. With offices in 46 countries and more than 16,000 professionals worldwide, PPD applies innovative technologies, therapeutic expertise and a firm commitment to quality to help clients and partners bend the cost and time curve of drug development to deliver life-changing therapies that improve health. 40

44 회사명 주소 Alpha Biologics Plot 302, Jalan Perindustrian Bukit Minyak 20, Penang Science Park, Pulau Pinang 웹사이트 이름 Contact point 전화번호 , 설립일 2003 직원수업종 R&D 제조 유통 CRO CMO 컨설팅 기타 비고 Alpha Biologics is a contract bio-manufacturing organization offering process development and FDA/EMEA cgmp compliant services to the worldwide pharmaceutical and biotechnology industry. Initial process development is undertaken by Alpha's highly experienced team in Cambridge, UK, before being transferred to the 5,000 sq meter facility in Malaysia for final process technology transfer and manufacturing of biologics drugs for pre-clinical and clinical trials. The facility has been designed to produce primarily mammalian cell secreted proteins, including monoclonal antibodies and recombinant proteins. Managed by a team of specialists with significant cgmp manufacturing experience in the US, Europe and Asia that will ensure the highest standards of production and regulatory compliance. Future expansion plans in two stages are to add a 'fill/finish' operation and a microbial cell facility. We specialize in the production of mammalian cell secreted protein drugs, and we provide all of the necessary services required to develop and produce our clients' drugs in full compliance with U.S. and European cgmp guidelines. Our manufacturing base in Malaysia brings significant cost advantages to our customers due to the lower overhead costs compared with Europe or the U.S., whilst maintaining the highest standards of compliance. 41

45 비고 Our core team has extensive experience of designing, building and operating cgmp compliant facilities for biologic drugs in the U.S. and Europe. The core team comprises internationally trained and experienced staff from the world-wide biologics industry and academia. Our goal is to deliver drugs on time for clinical trials at a price that is affordable, thereby enabling our clients' to maintain strong drug development pipelines and realize maximum value from the investments in research and development. 42

46 회사명 주소 웹사이트 Inno Bio Lot 1, Persiaran Negeri BBN, Putra Nilai, Nilai, Negeri Sembilan Contact point 이름 전화번호 설립일 직원수 업종 R&D 제조유통 CRO CMO 컨설팅기타 비고 We aspire to be a world leading business organization providing biopharmaceutical development and services for better quality of life. Our vision is the leader in innovative biologics development and manufacturing. InnoBio offers cell line development and protein expression services, antibody services including humanization, process development services and cgmp manufacturing. Inno Biologics is a globally operating Contract Manufacturer for monoclonal antibodies and therapeutic proteins with state-of-the-art cgmp Manufacturing Facility. 43

47 6. 참고문헌 년의약품해외시장진출을위한인허가및시장정보 Ⅰ( 중국, 싱가포르, 말레이시아, 인도네시아 ), 한국보건산업진흥원, Malaysia Regulatory System for Pharmaceutical Products 3. 한국의료해외진출가이드, 말레이시아 (Malaysia), 한국보건산업진흥원, World Economic Outlook Database April 2016, IMF, 참고사이트 1. 팜인포나루, 식품의약품안전처 2. 제약산업정보포털, 한국보건산업진흥원 3. 의료기관해외진출정보, 한국보건산업진흥원 4. KOTRA 해외비즈니스포털, 대한무역투자진흥공사 5. KOTRA 해외시장뉴스, 대한무역투자진흥공사 6. EMIS 7. Contract Research Map 8. Scientist

48 ( 바이오 ) 의약품해외진출지원을위한정보집 발 행 일 편 집 위 원 장 편 집 위 원 연 락 처 전 화 번 호 팩 스 번 호 : 2016년 10월 : 이경호 : 한국제약협회바이오의약품위원회 ( 한국제약협회바이오의약품정책실, 동아쏘시오홀딩스, 녹십자, 대웅제약, 유한양행, 일양약품, 종근당 ) : 한국제약협회바이오의약품정책실 : 02) ~1 : 02)