Regulatory Submissions

 

 

	Instructions for Use (IFUs) Instructions for Use or IFUs is information provided by the manufacturer to inform the user of a device's intended purpose, proper use, and any precautions. IFUs are used mainly in the medical field, specifically for prescription drugs and medical devices.
	Labeling Medicine labeling is the essential information provided by manufacturers about a device's purpose, usage, risks, and maintenance. This labeling ensures safe and effective use, assisting healthcare professionals and patients while meeting regulatory compliance.   Labels should include: - Name and business location of the medical device’s manufacturer, packer, or distributor. It must include the zip code, city, state, and street address. And if the business listed on the label is not the original manufacturer, the company must make it clear by including affirmative statements such as “Distributed by” or “Manufactured for.” - The intended use of the medical device. If sellers, distributors, or packers propose a different use than the manufacturer, they must clearly indicate the device’s new intended uses on the label. - Sufficient directions for use. Directions must be clear and straightforward enough for the average person to safely use the device for its intended purpose. These instructions should include conditions for device use and storage and disposal procedures.
	Regulatory Affairs Regulatory affairs are developed of governments to protect public health by controlling the safety and efficacy of products in areas including pharmaceuticals, veterinary medicines, medical devices, pesticides, agrochemicals, cosmetics and complementary medicines, and by the companies responsible for the discovery, testing, manufacture and marketing of these products wanting to ensure that they supply products that are safe and make a worthwhile contribution to public health and welfare.
	Package Information Leaflets (PILs) Package Information Leaflets (PILs) – are leaflets containing specific information about medical conditions, doses, side effects that packed with medicines to give the user information about the product.   PIL is the European version of the package insert. The PIL is written by the manufacturing pharmaceutical company. All licensed medicines need to carry such a leaflet.   Contant of the information:           Identification of the medicine           Therapeutic indications           Information necessary before taking medicine
	Patient Prescribing Information The package insert includes details and directions that health care providers need to prescribe a drug properly, including approved uses for the drug, contraindications, potential adverse reactions, available formulations and dosage, and how to administer the drug. The package insert is included with drug packaging and is used to develop any promotional or labeling materials.
	Common Technical Documents (CTDs) The Common Technical Document (CTD) is a set of specifications for a dossier for the registration of medicines.
	Quality Review Documents (QRD) The product information of medicinal products follows a specific template, the Quality Review of Documents (QRD) template. A distinction is made between templates for the Centralized procedure and templates for the Mutual recognition Procedure (MRP), Decentralized procedure (DCP) and referrals.
	Regulatory Dossiers Regulatory dossier is a package of documents, which may include all required information regarding newly developed drug products and/or generics, which is required by EU and US regulatory authorities for granting marketing authorization approvals. The main information that is included in the package is administrative information, data related to the quality, safety and efficacy of drug product, which can be submitted by CTD (Common Technical Document) format both paper and electronic version.
	Standard Operating Procedures (SOPs) Standard operating procedures for medical products outline recurring operations or processes and help to maintain quality and consistency. To remain compliant with regulatory agencies including the Federal Drug Administration (FDA) and International Organization for Standardization (ISO), medical device companies need to develop SOPs that outline a variety of operations, such as those for manufacturing, risk management, and training.
	Chemistry, Manufacturing and Control Documentation (CMC) CMC documents are documents prepared in accordance with the guidelines for Industry, Analytical methods and Verification procedures (Chemical, Manufacturing and Control documents) for analytical methods and validation procedures related to drug manufacture.