The quality standard (i.e., tests, analytical procedures, and acceptance criteria) provided in an approved application to confirm the quality of drug substances, drug products, intermediates, raw materials, reagents, components, in-process materials, container closure systems, and other materials used in the production of a drug substance or drug product. For the purpose of this definition, acceptance criteria means numerical limits, ranges, or other criteria for the tests described. FDA CFR 314[2]、FDA CFR 600
Labeling for such products includes but is not limited to:
Prescribing Information (PI):
Labeling includes three sections: Highlights of Prescribing Information (Highlights), a Table of Contents (Contents), and the Full Prescribing Information (FPI). Highlights contains selected information from the FPI that health care practitioners most commonly reference and consider most important. Contents lists the sections and subsections of the FPI. FPI contains the detailed prescribing information necessary for safe and effective use of the drug. The final rule also reordered and reorganized the FPI, made minor changes to the content of the FPI, and set minimum graphic requirements for the format of the labeling.[3]
FDA-approved patient labeling [Medication Guides, Instructions for Use, and Patient Information (also called Patient Package Inserts)]:
o Medication Guides are a type of FDA-approved patient labeling for drugs used primarily on an outpatient basis when the FDA determines that it is necessary for patient's safe and effective use.
o Instructions for Use (IFU) are a type of FDA-approved patient labeling for drugs that have complicated or detailed patient-use instructions. The IFU provides detailed, action-oriented, step-by-step written and visual instructions for the patient on how to use the drug including instructions on preparation, administration, handling, storage, and disposal.
o Patient Package Inserts (PPIs) are a type of FDA-approved patient labeling that are required for oral contraceptives (21 CFR 310.501) and estrogen-containing products (21 CFR 310.515). PPIs are voluntary for other prescription drug products.
Carton and container labeling
EMA
Summary of the product characteristics(SmPC): is the basis of information for healthcare professionals on how to use the medicinal product safely and effectively. The Package Leaflet (PL) shall be drawn up in accordance with the SmPC. The Guideline on excipients in the label and package leaflet of medicinal products for human use is also applicable to the SmPC.