JNDA definition

JNDA means a new drug application filed with the MHLW required for marketing approval for the applicable Product in Japan.
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JNDA means the Japanese equivalent of an NDA filed with the Koseisho (i.e., the Japanese Ministry of Health and Welfare, or any successor agency thereto).
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JNDA means a Japanese new drug application and any other applicable submission to the PMDA for pharmaceutical, biologic, or device approval.
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Examples of JNDA in a sentence

  • In the event that the PMDA determines, as documented in official, written correspondence with Sa▇▇, that the applicable Pre-Clinical Studies are not sufficient for approval of the JNDA, then the JC shall decide whether the applicable Pre-Clinical Studies should be repeated.

  • ARIAD shall, as a foreign manufacturer and supplier of the Product, comply with the Japanese Pharmaceutical Affairs Law, including with respect to the content and filing of the Quality Agreement for Japan and accreditation as a manufacturer at the time of filing the JNDA for Product.

  • The safety units from each of the Parties shall meet and agree upon written pharmacovigilance agreements for exchanging adverse event and other safety information relating to (i) the Development of Product within [**] ([**]) [**] of the Effective Date and (ii) the Commercialization of Product in connection with the first MAA (including a JNDA in the Territory or its equivalent outside of the Territory) for Product to be filed.

  • The Parties agree that new data developed under this Agreement that is filed to the JNDA for Final Product may also be filed concurrently to the JNDA for Alternative Final Product.

  • At any time, BMS and ImClone may agree to withdraw such Alternative Final Product JNDA.


More Definitions of JNDA

JNDA means a new drug application filed with the Koseisho required for marketing approval for the applicable Licensed Product in Japan.
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JNDA means a Japanese new drug application and any other applicable submission to the PMDA for pharmaceutical, biologic, or device approval. [See License Agreement Section 1.68]
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JNDA means a Japanese new drug application, or an amendment thereof filed with the MHLW through PMDA under Article 14 of the Pharmaceuticals and Medical Devices Act of Japan (Law No. 145 of 1960, as amended).
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JNDA means (i) the single application or set of applications for approval and/or pre-market approval to Manufacture and Commercialize in the Territory a pharmaceutical or biologic product filed with the MHLW, and any related registrations with or notifications to the MHLW, and (ii) all supplements and amendments that may be filed with respect to any of the foregoing.
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JNDA has the meaning set forth in Section 3.1(i).
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JNDA means an application for Regulatory Approval of a Licensed Product in the Otsuka Territory.
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JNDA means an NDA submitted to Regulatory Authority in Japan.
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