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Regulatory challenges with biosimilars: an update from 20 countries.
Kang, Hye-Na; Thorpe, Robin; Knezevic, Ivana; Casas Levano, Mary; Chilufya, Mumbi Bernice; Chirachanakul, Parichard; Chua, Hui Ming; Dalili, Dina; Foo, Freddie; Gao, Kai; Habahbeh, Suna; Hamel, Hugo; Kim, Gi Hyun; Perez Rodriguez, Violeta; Putri, Desi Eka; Rodgers, Jacqueline; Savkina, Maria; Semeniuk, Oleh; Srivastava, Shraddha; Tavares Neto, João; Wadhwa, Meenu; Yamaguchi, Teruhide.
Afiliação
  • Kang HN; Department of Health Product Policy and Standards, World Health Organization, Geneva, Switzerland.
  • Thorpe R; Independent Expert, Welwyn, United Kingdom.
  • Knezevic I; Department of Health Product Policy and Standards, World Health Organization, Geneva, Switzerland.
  • Casas Levano M; General Directorate of Medicines Supplies and Drugs (DIGEMID), San Miguel, Peru.
  • Chilufya MB; Zambia Medicines Regulatory Authority, Lusaka, Zambia.
  • Chirachanakul P; Food and Drug Administration, Nonthaburi, Thailand.
  • Chua HM; National Pharmaceutical Regulatory Agency, Selangor, Malaysia.
  • Dalili D; Iran Food and Drug Administration, Tehran, Iran.
  • Foo F; Health Sciences Authority, Singapore.
  • Gao K; Shanghai University, Shanghai, People's Republic of China.
  • Habahbeh S; Jordan Food and Drug Administration, Amman, Jordan.
  • Hamel H; Health Canada, Ottawa, Ontario, Canada.
  • Kim GH; Ministry of Food and Drug Safety, Osong-eup, Republic of Korea.
  • Perez Rodriguez V; Centro para el Control Estatal de Medicamentos, Equipos y Dispositivos Médicos (CECMED), La Habana, Cuba.
  • Putri DE; The Indonesian Food and Drug Authority, Jakarta, Indonesia.
  • Rodgers J; Food and Drugs Authority, Accra, Ghana.
  • Savkina M; The Federal State Budgetary Institution "Scientific Centre for Expert Evaluation of Medicinal Products" of the Ministry of Health, Moscow, Russian Federation.
  • Semeniuk O; Ministry of Health of Ukraine, Kyiv, Ukraine.
  • Srivastava S; Central Drug Standards Control Organization (CDSCO), Ministry of Health & Family Welfare, New Delhi, India.
  • Tavares Neto J; Brazilian Health Regulatory Agency (ANVISA), Brasilia, Brazil.
  • Wadhwa M; National Institute for Biological Standards and Control, Medicines and Healthcare products Regulatory Agency, Potters Bar, United Kingdom.
  • Yamaguchi T; Pharmaceuticals and Medical Devices Agency, Tokyo, Japan.
Ann N Y Acad Sci ; 1491(1): 42-59, 2021 05.
Article em En | MEDLINE | ID: mdl-33222245
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Texto completo: 1 Base de dados: MEDLINE Assunto principal: Aprovação de Drogas / Medicamentos Biossimilares / Farmacovigilância Tipo de estudo: Guideline / Prognostic_studies / Qualitative_research Limite: Humans Idioma: En Revista: Ann N Y Acad Sci Ano de publicação: 2021 Tipo de documento: Article País de afiliação: Suíça
Texto completo
Imprimir
XML
PubMed Links
Buscar no Google

Texto completo: 1 Base de dados: MEDLINE Assunto principal: Aprovação de Drogas / Medicamentos Biossimilares / Farmacovigilância Tipo de estudo: Guideline / Prognostic_studies / Qualitative_research Limite: Humans Idioma: En Revista: Ann N Y Acad Sci Ano de publicação: 2021 Tipo de documento: Article País de afiliação: Suíça