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Review
Comparative analysis of GMO regulatory requirements for AAV vectors in the EU and Japan focusing on the shedding data and containment measures
Hirokuni Mizoguchia Astellas Pharma Inc., Regulatory Affairs, Chuo-ku, Tokyo, Japan;b Forum for Innovative Regenerative Medicine, Chuo-ku, Tokyo, JapanCorrespondence[email protected]
https://orcid.org/0009-0001-3027-5190View further author information
Tobias Fleischmannc Pfizer Pharma, GmbH, Biotransformation and Environmental Sciences, Berlin, GermanyView further author information
, Masato Komurod Sanofi K.K., Regulatory Affairs, Shinjuku-ku, Tokyo, Japan;e Japan Pharmaceutical Manufacturers Association, Chuo-ku, Tokyo, JapanView further author information
, Takahiro Hiraif GlaxoSmithKline K.K., Akasaka Intercity AIR, Minato-ku, Tokyo, Japan;g EFPIA Japan (European Federation of Pharmaceutical Industries and Associations, Japan), Shinjuku-ku, Tokyo, JapanView further author information
, Akiko Ikedah Janssen Japan K.K., Regulatory Affairs, Chiyoda-ku, Tokyo, JapanView further author information
, Kojiro Saitog EFPIA Japan (European Federation of Pharmaceutical Industries and Associations, Japan), Shinjuku-ku, Tokyo, Japan;i Chugai Pharmaceutical Co. Ltd., Regulatory Affairs, Chuo-ku, Tokyo, JapanView further author information
, Tomohiro Watahikih Janssen Japan K.K., Regulatory Affairs, Chiyoda-ku, Tokyo, JapanView further author information
& Gentaro Tajimaj Pfizer R&D Japan G.K., Regulatory Sciences, Shibuya-ku, Tokyo, JapanView further author information
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Pages 529-542
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Received 09 Apr 2024, Accepted 18 Jun 2024, Published online: 28 Jun 2024
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