Regulatory Requirements

Regulatory Requirements. Those laws, regulations and guidelines that are current during the Term and which are applicable to the countries in which the Study is being conducted or are applicable to the class of pharmaceutical product being tested or the clinical specialty involved

Regulatory Requirements. All laws, regulations, and other legal requirements applicable to the manufacture of API, CTM or the use thereof, including without limitation cGMP, FDA regulations, any applicable local laws and regulations in the place of manufacture, storage and handling, and any requirements set forth in an IND, NDA, Marketing Approval Application (MAA) and other regulatory filings or approvals.