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[부록] 연구대상국별 허가참조제도 최신 자료원
1) EU 상호인정 허가참조제도
문서/웹사이트 제목 발행일 URL
European Medicines Agency (EMA) 2020 https://www.ema.europa.eu/en 의약품 수출입 지원을 위한 의약품 허가·심사 체계
연구 – 유럽 [식품의약품안전처] 2019.11 https://rnd.mfds.go.kr/#!RDCAC09F01View EudraLex 제2권
Directive 2001/83/EC Regulation (EC) No 726/2004
2) ACCESS 상호인정 허가참조제도
문서/웹사이트 제목 발행일 URL
Singapore Health Sciences Authority. Access
Consortium 2020.9 https://www.hsa.gov.sg/therapeutic-products/international- collaboration-therapeutic-products/access
Singapore Health Sciences Authority. FACILITATING ACSS WORK SHARING FOR NEW CHEMICAL AND BIOLOGICAL ENTITIES
2019.7 https://www.hsa.gov.sg/docs/default-source/announcements/
regulatory-updates/guidance-for-industry-docx.pdf
Singapore Health Sciences Authority. Terms of
Reference 2020.9 https://www.hsa.gov.sg/docs/default-source/gdo/international- collaboration/ich/access_tor_revised_september2020.pdf
3) 나이지리아 일방인정 허가참조제도
문서/웹사이트 제목 발행일 URL
의약품 해외시장 진출을 위한 인허가 및 시장정보II 이집트/나이지리아
[한국보건산업진흥원]
2016.12
Drug and related products registration regulations
2019 2019
https://www.nafdac.gov.ng/wp-content/uploads/Files/
Resources/Regulations/All_Regulations/Drugs-and-Related- Products-Registration-Regulations-2019.pdf
Quality guidelines for the registration of
pharmaceutical products for human use in Nigeria 2018.6
https://www.nafdac.gov.ng/wp-content/uploads/Files/
Resources/Guidelines/R_and_R_Guidelines/GENERAL/Quality- Guidelines-for-Registration-of-Pharmaceutical-Products26381.pdf
NAFDAC good manufacturing practice guidelines
for pharmaceutical products 2016 2016
https://www.nafdac.gov.ng/wp-content/uploads/Files/
Resources/Guidelines/DRUG_GUIDELINES/NAFDAC-GMP- GUIDELINES-FOR-PHARMACEUTICAL-PRODUCTS-2016.pdf
나이지리아 바이오시밀러 등록법 2012.12
https://www.nafdac.gov.ng/wp-content/uploads/Files/
Resources/Guidelines/R_and_R_Guidelines/LOCAL/Guidelines-for- Registration-of-Biosimilars-in-Nigeria-101212.pdf
나이지리아 수입의약품 등록 지침
(NAFDAC/RR/002/00) 2018.6
https://www.nafdac.gov.ng/wp-content/uploads/Files/
Resources/Guidelines/R_and_R_Guidelines/IIMPORTS/Guidelines-
for-the-Registration-of-Imported-Drug-Products.pdf
2 4) 남아프리카공화국 일방인정 허가참조제도
문서/웹사이트 제목 발행일 URL
의약품 해외시장 진출을 위한 인허가 및 시장정보I
남아공/케냐 [한국보건산업진흥원] 2016.12
Medicines Registration: SAHPRA [SAHPR의 식약처
발표자료] 2018.9
Guidance for the submission of the South African
CTD/eCTD – general & Module 1 2019.5 https://www.sahpra.org.za/wp-content/uploads/2020/02/2.01- Guidance_General_Module_1_May19_v6-1.pdf
Quality and bioequivalence guideline 2019.7 https://www.sahpra.org.za/wp-content/uploads/2020/02/
2.02_Quality-and-Bioequivalence-Guideline_Jul19_v7-1.pdf Clinical guideline 2019.7 https://www.sahpra.org.za/wp-content/uploads/2020/02/
2.09_Clinical-Guideline_Jul19_v2-1.pdf SA Guide to good manufacturing practice for
medicines 2019.7 https://www.sahpra.org.za/wp-content/uploads/2020/02/
4.01_SA-Guide-to-Good-Manufacturing-Practice_Jul19_v7-1.pdf Guideline for the API master file (APIMF) procedure 2020.6 http://www.sahpra.org.za/wp-content/uploads/2020/07/
2.59_Guideline-for-the-APIMF-Procedure_June2020_v1.pdf 의약품 및 관련 물질법 (Medicines and Related
Substances Act, Act No. 101)
5) 말레이시아 일방인정 허가참조제도
문서/웹사이트 제목 발행일 URL
2014년 의약품 해외시장 진출을 위한 인허가 및 시장정보 I: 중국·싱가포르· 말레이시아·인도네시아 [한국보건산업진흥원]
2014.12
말레이시아 의약품허가제도 [식품의약품안전처] 2015.12
Drug Registration Guidance Document (DRGD) 2020.7 https://www.npra.gov.my/index.php/en/drug-registration- guidance-documents-drgd-e-book.html
Guidance Document Foreign GMP Inspection 2018.7 https://www.npra.gov.my/images/Guidelines_Central/Inspection/
GuidanceDocumentForeignGMPInspection.pdf
Product Registration Process https://www.npra.gov.my/index.php/en/product-registration- process.html
의약품판매법(법률 368호, 1952 신설, 1989 개정) http://www.bpfk.gov.my
6) 베트남 일방인정 허가참조제도
문서/웹사이트 제목 발행일 URL
베트남 의약품허가제도
[APEC 규제조화센터] 2017.12
의약품 인허가 규제정보현황 PARTII : 한국베트남
의약품 인허가 정책 비교분석 [식품의약품안전처] 2019.10
3
문서/웹사이트 제목 발행일 URL
Pharmaceutical market and regulatory environment
in Asia (PMRE), ver.2019 2020.04 http://en.phirda.com/upload/editor/file/20200421/21170745337.p df
Decree 54/2017/ND-CP
Guidelines for implementation of the Law on Pharmacy
2017.05 https://vanbanphapluat.co/decree-54-2017-nd-cp-guidelines-for- implementation-of-the-law-on-pharmacy
Circular #11,2018,
Amendment, Circular #03,2020 Quality of drugs and drug materials.
2018.05 2020.01
Circular #32,2018
Marketing authorization for drugs and medicinal ingredients
2018.12
Circular #35/2018/
Good practice of producing drugs and raw materials for drug making
2018.11
7) 싱가포르 일방인정 허가참조제도
문서/웹사이트 제목 발행일 URL
2014년 의약품 해외시장 진출을 위한 인허가 및 시장정보 I: 중국·싱가포르·
말레이시아·인도네시아 [한국보건산업진흥원]
2014.12
싱가포르 의약품허가제도 [식품의약품안전처
식품의약품안전평가원] 2015.12
GUIDANCE ON THERAPEUTIC PRODUCT
REGISTRATION IN SINGAPORE 2019.1 https://www.hsa.gov.sg/therapeutic-products/guidance- documents
의약품법(The Medicines Act) http://statutes.agc.gov.sg
8) 인도네시아 일방인정 허가참조제도
문서/웹사이트 제목 발행일 URL
인도네시아 의약품허가제도 [APEC 규제조화센터] 2017.12 Drug Approval System in Indonesia by
Badan Pengawas Obat dan Makanan (Badan POM) Republic of Indonesia
2019.1 https://www.indianembassyjakarta.gov.in/pdf/AN_OVERVIEW_OF_
THE_DRUG_REGULATORY_SYSTEM_IN_INDONESIA_jan31-19.pdf
Pharmaceutical market and regulatory environment
in Asia (PMRE), ver.2019 2020.4 http://en.phirda.com/upload/editor/file/20200421/21170745337.p df
Criteria and Drug Registration Procedure (Regulation 24/2017)
Amendment (Regulation 15/2019:)
2017.11 2019.7
Guidelines on GMP for Drugs (Regulation 34/2018) Amendment (Regulation 7/2019)
2018.12
2019.4
4 9) 스위스 일방인정 허가참조제도
문서/웹사이트 제목 발행일 URL
의약품 수출입 지원을 위한 의약품 허가·심사 체계
연구 – 유럽 [식품의약품안전처] 2019.11 https://rnd.mfds.go.kr/#!RDCAC09F01View
Therapeutic Products Act (TPA) https://www.admin.ch/opc/en/classified- compilation/20002716/index.html Therapeutic Products Ordinance (TPO) https://www.admin.ch/opc/de/classified-
compilation/20173471/index.html Guidance document
Authorisation human medicinal product under Art. 13 TPA HMV4
2018
https://www.swissmedic.ch/swissmedic/en/home/legal/legal- basis/administrative-ordinances.html
Directory List countries with comparable control of human medicinal products HMV4 2019
10) 멕시코 일방인정 허가참조제도
문서/웹사이트 제목 발행일 URL
