Review of chromatographic packing DMF

Drug Master File A master document that reflects a complete set of documentation for pharmaceutical production and quality management. It mainly includes the manufacturer's profile, specific quality specifications and inspection methods, production process and equipment description, quality control and quality management.

Type of drug DMF

Different countries and regions have different requirements for registration procedures and DMF writing. They can be roughly divided into two types. One is the DMF (referred to as EDMF) required by the European Union countries, also known as ASMF (Active Material Master Document); It is required by the US FDA. The former requirement focuses on the data and data on process quality control, impurity and stability research; the latter DMF is subdivided into five categories. On the basis of EDMF, it is necessary to introduce the plant and facilities of the production plant. Content of personnel, GMP management, organization and responsibilities.

The role of DMF

In the European Community, DMF is part of the marketing license. Drugs must be declared in the European Community or the National Drug Administration for a set of information, and the market sales license. When the active ingredient used in the drug (ie, the supplier of the drug substance changes, the same as above. DMF is an important part of the application. If the DMF is not provided as required, the product produced cannot be sold to the country.

DMF application

In the United States, although the FDA does not have official documents to export raw materials to the United States must report DMF information, but in fact everyone is doing, and the US FDA has also published guidelines for the preparation of DMF documents. If the drug substance is used as a component of a prescription drug, the FDA must send a check to the manufacturer to determine whether the plant's production is consistent with the reported data, whether it is in accordance with US CGMP (current GMP) requirements. Given the strict management of imported APIs by the European Community and the United States, the preparation of a DMF document that meets the requirements is essential to facilitate the export of APIs.

DMF application type

Type I, manufacturing site, facilities, work procedures, personnel (no longer applicable)

Type II, API, API intermediate, material and preparation method thereof, or pharmaceutical product

Type III, packaging materials

Type IV, excipients, colorants, perfumes, or materials used and methods for preparing same

Type V, FDA approved reference information.

The number of Global Drug Master File (DMF) applications and the number of approved new drug applications (ANDA) reflects the company's R&D capabilities and the ability to launch generic drugs. Due to the lack of high-level new formulations and international registration experience, Chinese pharmaceutical companies are DMF documents, ANDA applications and FDA-approved bases are far behind other countries. Lack of these certifications will lose our voice in mainstream markets such as Europe and the United States.

China and India belong to the same developing country. From the point of view of the time and quantity of application for approval, China has been behind India for about 5 years in the development level of APIs, and its formulation has fallen behind for about 10 years. India has had the first ANDA since 1998, and China's first ANDA is the temporary ANDA approval of Nevillela obtained by Huahai Pharmaceutical in 2007; the number of FDA production bases approved in China is about 40, and There are 200 in India; the number of ANDAs approved in China is 10, and most of them are obtained through the acquisition of US companies. India has 591 ANDAs as of 2009, and only 140 applications in 2009. According to the experience of Indian companies, the approval period for applying for ANDA is about 3 years, and the investment of each ANDA is 1 million yuan - 2 million US dollars. Therefore, Chinese enterprises need to have enough patience and input to form a competition. Forceful.