第一单位：
National Institute for Biological Standards and Control, Medicines and Healthcare Products Regulatory Agency, Potters Bar, United Kingdom.
作者：
Meenu,Wadhwa [1]
;
Hye-Na,Kang [2]
;
Robin,Thorpe [3]
;
Ivana,Knezevic [4]
;
following participants of the WHO informal consultation on revision of guidelines on evaluation of similar biotherapeutic products [5]
;
P,Aprea [6]
;
M-C,Bielsky [7]
;
N,Ekman [8]
;
H-K,Heim [9]
;
J,Joung [10]
;
P,Kurki [11]
;
E,Lacana [12]
;
C,Njue [13]
;
E,Nkansah [14]
;
M,Savkina [15]
;
R,Thorpe [16]
;
T,Yamaguchi [17]
;
M,Wadhwa [18]
;
J,Wang [8]
;
M,Weise [19]
;
E,Wolff-Holz ;
Other participants ;
Representatives of the Developing Countries Vaccine Manufacturers Network ;
Representatives of the Emerging Biopharmaceutical Manufacturers Network ;
Representatives of the IFPMA ;
Representatives of IGBA ;
Representative of the Latin American Association of Pharmaceutical Industries ;
Representative of the Singapore Association of Pharmaceutical Industries ;
WHO Secretariat
作者单位：
National Institute for Biological Standards and Control, Medicines and Healthcare Products Regulatory Agency, Potters Bar, United Kingdom.
[1]
World Health Organization, Department of Essential Medicines and Health Products, Avenue Appia 20, CH-1211, Geneva, Switzerland. Electronic address: kangh@who.int.
[2]
Independent Expert, Welwyn, United Kingdom.
[3]
World Health Organization, Department of Essential Medicines and Health Products, Avenue Appia 20, CH-1211, Geneva, Switzerland.
[4]
Administración Nacional de Medicamentos, Alimentos y Tecnología Medica, Argentina.
[5]
Medicines and Healthcare Products Regulatory Agency, United Kingdom.
[6]
Finnish Medicines Agency, Finland.
[7]
Federal Institute for Drugs and Medical Devices, Germany.
[8]
Ministry of Food and Drug Safety, Republic of Korea.
[9]
University of Helsinki, Finland.
[10]
United States Food and Drug Administration, USA.
[11]
Health Canada, Canada.
[12]
Food and Drug Authority, Ghana.
[13]
Federal State Budgetary Institution Scientific Centre for Expert Evaluation of Medicinal Products, Russian Federation.
[14]
Independent Expert, United Kingdom.
[15]
Pharmaceuticals and Medical Devices Agency, Japan.
[16]
National Institute for Biological Standards and Control, Medicines and Healthcare Products Regulatory Agency, United Kingdom.
[17]
Health Canada, Canada; National Institutes for Food and Drug Control, China.
[18]
Paul-Ehrlich-Institut, Germany.
[19]
DOI
10.1016/j.biologicals.2022.03.001
PMID
35466023
发布时间
2022-07-16
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