Regulatory Strategy definition

Regulatory Strategy means, with respect to a Product in a country in the Territory, the strategy for conducting the interactions with Regulatory Authorities needed to develop such Product for such country and to obtain and maintain Regulatory Approval of such Product in such country, including making Regulatory Filings (including INDs, NDAs, and amendments thereto) and developing and implementing risk evaluation and mitigation strategies.
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Regulatory Strategy means the strategy of a regulatory authority referred to in section 15;
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Regulatory Strategy means a reasonably detailed written plan prepared by E-Z-EM outlining its strategy for achieving Marketing Authorizations in all member states in the Territory mutually agreed by the parties, as amended from time to time by E-Z-EM, including lists of tasks to be accomplished, time lines for completion of various tasks necessary to obtain the Marketing Authorizations, including details of plans to obtain the national licenses.
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Examples of Regulatory Strategy in a sentence

  • The Regulatory Strategy Framework shall also apply to any decision of a Party to (i) agree to stay, toll or extend the waiting period under the HSR Act with respect to the Transactions, (ii) withdraw and thereafter refile its Notification and Report Form pursuant to the HSR Act in accordance with 16 C.F.R. § 803.12 and any other applicable Laws or (iii) enter into timing or similar agreements with any Governmental Entity.

  • On a quarterly basis, E-Z-EM shall provide Pharmacyclics with an updated version of the Regulatory Strategy, including changes in time lines and a written report on the status of all efforts by E-Z-EM to obtain Pricing and Reimbursement Approvals.

  • Once the JSC has approved a Product Regulatory Strategy, each Party will use Commercially Reasonable Efforts to execute its respective tasks and responsibilities within the time frames set forth in such Product Regulatory Strategy.

  • For clarity, the JSC will not have any approval rights with respect to the Regulatory Strategy for any Drug Discovery Program and Ionis will have sole control over, and sole decision-making authority with respect to, the Regulatory Submissions for the Licensed Products.

  • After the Effective Date, except to the extent required by a Regulatory Authority in a country in the Akcea Territory or as set forth in Section 2.4.2, Akcea may not make any changes to the Ionis Pharmaceuticals/Akcea Product Regulatory Strategy that would have a material adverse effect on the timing or likelihood of obtaining Regulatory Approval in a country in the PTC Territory.

  • The applicable Regulatory Lead Party will develop and submit to the JSC to review, discuss and determine whether to approve the packaging and labeling for each Licensed Product in the Profit-Share Territory, which in all cases will be consistent with the applicable Profit-Share Regulatory Strategy and in compliance with applicable Law.

  • Regulatory Materials with respect to any Licensed Product in the Profit-Share Territory must be consistent with the Profit-Share Regulatory Strategy for such Licensed Product approved by the JSC.

  • Within thirty (30) days after the Effective Date, E-Z-EM shall submit its Regulatory Strategy to Pharmacyclics for its review and comment.

  • Any Material Communication to a Regulatory Authority with respect to any Licensed Product in the Profit-Share Territory must be consistent with the Profit-Share Regulatory Strategy for such Licensed Product approved by the JSC.

  • Each Party will bear its own costs and expenses associated with any activities that such Party performs in support of the implementation of such Product Regulatory Strategy.


More Definitions of Regulatory Strategy

Regulatory Strategy has the meaning set forth in Section 7.1 (Regulatory Responsibility).
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Regulatory Strategy means the principal regulatory considerations that are associated with Product development during the Development Program as set forth in Exhibit C.
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Regulatory Strategy has the meaning ascribed to such term in Section 3.1. 1.1. 104. “Site” means the study site, Providence Cancer Institute, for a Phase I/II Clinical Trial, to be approved by the JSC in accordance with Section 2.7.
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Regulatory Strategy. Subpart H Approval for PFIC with Post-Approval Long-Term Outcome Study Seek accelerated approval for PFIC treatment using surrogate endpoint Study planning ongoing; assessing serum bile acids, pruritus and sleep as endpoints following FDA discussions Long-term outcome study to be underway at the time of NDA filing CFR Title 21, Section 314.510: “FDA may grant marketing approval for a new drug product on the basis of adequate and well-controlled clinical trials establishing that the drug product has an effect on a surrogate endpoint that is reasonably likely, based on epidemiologic, therapeutic, pathophysiologic, or other evidence, to predict clinical benefit or on the basis of an effect on a clinical endpoint other than survival or irreversible morbidity.” Request for pre-Phase 3 FDA meeting planned Q4 2016 A4250
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Related to Regulatory Strategy

  • Regulatory Submissions means any filing, application or submission with any Regulatory Authority, including authorizations, approvals or clearances arising from the foregoing, including Regulatory Approvals and any pricing or reimbursement approvals, as applicable, and all correspondence or communication with or from the relevant Regulatory Authority, as well as minutes of any material meetings, telephone conferences or discussions with the relevant Regulatory Authority, in each case, with respect to a Licensed Product.

  • Regulatory Filing means any documentation comprising or relating to or supporting any filing or application with any Regulatory Authority with respect to any compound or product (including any Licensed Compound or Licensed Product), or its use or potential use in humans, including any documents submitted to any Regulatory Authority and all supporting data, including INDs and NDAs, and all correspondence with any Regulatory Authority with respect to such compound or product (including minutes of any meetings, telephone conferences or discussions with any Regulatory Authority).

  • Regulatory Approval Application means an application to seek regular or expedited Regulatory Approval of the Licensed Product for sale or marketing in any country(ies) or Region(s) in the Territory, as defined in the applicable Laws and filed with the Regulatory Authority of such country(ies) or Region(s).

  • Regulatory Data means any and all research data, pharmacology data, chemistry, manufacturing and control data, preclinical data, clinical data and all other documentation submitted, or required to be submitted, to Regulatory Authorities in association with regulatory filings for the Product (including any applicable Drug Master Files (“DMFs”), Chemistry, Manufacturing and Control (“CMC”) data, or similar documentation).

  • Strategy means the Department of Education International Risk Management Strategy for Homestays and Short Term Cultural Exchanges developed and implemented under section 171 of the Working With Children (Risk Management and Screening) Act 2000 as in force at any given time.