Regulatory Requirements

Regulatory Requirements. Means any and all legal and regulatory standards, procedures, protocols, guidelines or requests of any Regulatory Authority having jurisdiction over the Product or the Manufacture thereof.

Regulatory Requirements. See the last paragraph of this Section.

Regulatory Requirements. Means (i) any and all permits, licenses, filings and certifications required by the US Food and Drug Administration (FDA), US Occupational Safety and Health Administration (OSHA), US Environmental Protection Agency (EPA), The International Conference of Harmonization Q7 (ICH Q7), The United States Pharmacopeia, (USP), The European Pharmacopeia (EP), the European Medicines Agency (EMEA), and compliance with the cGMP of the FDA, ICH Q7, USP, EP and EMEA, applicable to any manufacturing or... processing activities hereunder or facilities at which any of the manufacturing or processing activities hereunder are performed, and (ii) any Laws, rules, guidelines, regulations, and standards of any governmental authority within the United States (including, without limitation, EPA, OSHA, the Drug Enforcement Administration (DEA) and state and local authorities), that apply to any manufacturing or processing activities hereunder or the Facility or other facilities at which any of the manufacturing or processing activities hereunder are performed. View More

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.