PMDA Filing means the acceptance by the PMDA of the filing of an MAA for the applicable Licensed Product in Japan.
PMDA means Japan’s Pharmaceuticals and Medical Devices Agency or any successor entity thereto.
NDA means a New Drug Application, as defined in the regulations promulgated by the United States Food and Drug Administration, or any foreign equivalent thereof.
Regulatory Authorities means the Commissions and the Exchange;
Marketing Authorization means all approvals from the relevant Regulatory Authority necessary to market and sell a Product in any country (including without limitation, all applicable pricing and governmental reimbursement approvals even if not legally required to sell Product in a country).
MAA means a Marketing Authorization Application, in relation to any Product, filed or to be filed with the EMA (or equivalent national agency), for authorization to place a medicinal product on the market in the European Union (or any other territory).
FDA means the United States Food and Drug Administration or any successor agency thereto.