A. About DMF
1, DMF is the English DRUG MASTER FILE abbreviation, translated as "Drug Master File" (a translation of the "drug file"). It is a complete set of documents describing the production and quality control of the product, including the manufacturer's finished product quality standards and test methods, production process description, material control, impurity control, stability and other quality control aspects.
According to the U.S. Food, Drug, and Cosmetic Act (referred to as the FDCA), drugs (preparations) must be marketed to the U.S. FDA to submit an application for registration of the drug (NDA, ANDA, NADA and INDA), to provide the proposed listing of drugs and their ingredients and containers in the "safety, efficacy and quality" of all three aspects of information. The FDA will make a comprehensive evaluation of the drug and its components and containers in the "safety, efficacy and quality" of all three aspects of the information, the FDA to make a comprehensive evaluation that meets the requirements to give approval before the market.
However, regardless of whether the raw materials (APIs and excipients) and containers used by the manufacturer of the formulation are produced by the manufacturer itself, a variety of technical information about the APIs, excipients, or containers are required to be submitted in the marketing application for the formulation for use in the FDA's review. Typically, manufacturers supplying ingredients or containers are reluctant to disclose technical information about their products to unofficial third parties, including formulator users. To address this issue, FDA has established the DMF program, which allows for the required technical content to be submitted directly to FDA in the form of a DMF document by the raw material ingredient or container supplier in support of a formulation's marketing application in cases where the raw material ingredient or container manufacturer is unwilling to divulge relevant information about its own product to an unofficial third party.
2. According to the different objects of providing information, FDA classifies DMFs into the following five types:
Type I: organization and personnel, facilities and equipment, and standard operating procedures;
Type II: APIs, intermediates, and their raw materials, and preparations drugs;
Type III: packaging materials- -Containers;
Type IV: excipients, colorants, flavors and their raw materials;
Type V: other information acceptable to the FDA;
One of them: Type I DMFs are no longer accepted by the FDA.
3, DMF filing has the following benefits:
(1) simplify the content of the preparation application, directly to the DMF filing number to replace the preparation of the application data on the raw materials, direct contact with the specific information of the drug container information, so that the DMF filing number of the product can be in the same species of enterprises in the competition by the preparer to give priority to the competition and obtain a competitive advantage;
(2) companies and their products that have obtained a DMF registration number can more easily find opportunities to bring in more customers;
(3) reduce the risk of leakage of corporate technical secrets due to the provision of information to a large number of formulation customers;
(4) FDA can update the content at any time as requested by the registered companies.
Two, about NDC
1, NDC (National Drug Code) is a drug as a general commodity identification symbol. NDC database can be publicly queried, which includes all prescription drugs and over-the-counter drugs, but excludes veterinary drugs, blood products, and non-final marketed drugs (such as APIs).
2. Before any drug can be marketed in the U.S., it must be registered with an NDC number. The main information registered includes the name of the drug, the manufacturer, the drug classification, the route of administration, the date of marketing, the OTC monograph number, and labeling information. Drugs with an NDC number can be marketed in the U.S. based on compliance with the FDA's relevant drug administration laws. Distributors and end users can inquire about the efficacy and characteristics of the product based on this number, and the FDA also manages the product based on this number.
The NDC is a registration system for drug information only, and registration of a product in the NDC database does not imply that the drug has been approved by the FDA or can be marketed as a drug, nor does it imply that the product is eligible for medical reimbursement or that it is covered by another organization.
FDA regulations require that the registration system be updated in June and December of each year or that changes be reported at any time when changes occur.