Proposal for the revision of the guidelines for Non-clinical studies of vaccines for the prevention of infectious diseases in Japan

Author:

Nomura Yumiko,Noda Kiyohito,Oohashi Yuusuke,Okuda Shin,Maki Kazushige,Ogawa Takashi,Nakano Takashi,Tsuchida Nao,Ishii Ken J.,Hayashi Kunihiko,Iiyama Tatsuo,Onodera Hiroshi,Ishii Koji,Shikano Mayumi,Okabe Nobuhiko

Publisher

Elsevier BV

Subject

Infectious Diseases,Public Health, Environmental and Occupational Health,General Veterinary,General Immunology and Microbiology,Molecular Medicine

Reference30 articles.

1. World Health Organization. Development together the vision and strategy for immunization 2021–2030, https://www.who.int/immunization/ia2030_Draft_Zero.pdf;2009 .

2. Non-clinical vaccine safety assessment;Verdier;Toxicology,2002

3. Ministry of Health, Labour and Welfare. PSEHB/PED Notification No.0527-1 “Guidelines for Non-Clinical Studies of Vaccines for the Prevention of Infectious Diseases” (in Japanese);2010.

4. Ministry of Health, Labour and Welfare. Vaccine industry. Vision (in Japanese) 2019, https://www.mhlw.go.jp/shingi/2007/03/dl/s0322-13d.pdf;2007.

5. European Federation of Pharmaceutical Industries and Associations in Japan. Vaccines in Japan toward further innovation - Recent changes and future prospects (in Japanese), http://efpia.jp/link/Vaccine2.pdf;2018.

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