Carding | NK cell immunotherapy research enterprise
What is DMF?
The DMF file management system, generally called the Drug Master File (DMF) system, is mainly divided into 5 types, namely:
Category I: manufacturing sites, facilities, work procedures, and personnel (this category has been cancelled).
Class II: APIs, API intermediates, materials and their preparation methods, or pharmaceutical products.
Class III: Packaging materials.
Category IV: excipients, colorants, perfumes, or materials used and their preparation methods.
Type V: FDA approved reference information.
According to the Federal Regulations of the United States, it is necessary to apply to the US FDA for registration and submit relevant documents and DMF (Drug Master File) before the drug is marketed, so that the FDA can have a comprehensive understanding of the factory's products and determine that the production of the drug is guaranteed through GMP of.
The existing registration and licensing system procedures are cumbersome. When registering a new product, a series of inspection reports that meet GMP standards and related pre-clinical and clinical studies need to be provided, including the relevant technical content of the API and excipients used in the production process of the product However, preparing these materials will inevitably consume a lot of time and energy, and the complexity is equivalent to registering a new drug, which will seriously affect the clinical application process. If these raw materials have ready-made DMF filing materials, they can be directly quoted when applying, which can save a lot of manpower, material resources and time.
Some raw material suppliers may be reluctant to disclose their own technical information due to various considerations, which also hinders the use of new excipients by drug research and development companies.
The implementation of DMF can save review materials, reduce repeated declarations, and speed up the audit of raw and auxiliary materials by preparation manufacturers. When the preparation manufacturer submits the registration application materials to the FDA, the DMF file number is used to directly replace the specific materials related to the excipients and packaging materials in the preparation application materials, which not only simplifies the content of the preparation application, but also reduces the raw material enterprises to provide many preparation customers. Data and cause the risk of leakage of corporate technology secrets.
About AMMS®NK kit (medium + activation amplification reagent combination)
The AMMS®NK kit set independently developed by Tongli Haiyuan has completed the US FDA DMF filing (FDA DMF number: 035588). NK, CAR-NK cell therapy research projects may directly quote the kit DMF filing number to save product review And evaluation time, simplifying the preparation of new drug clinical application.
If you have used Tongli Haiyuan’s DMF registered products and need to quote the DMF number, please send an email to firstname.lastname@example.org to apply for authorization. After confirming with you, we will provide the FDA with a DMF authorization letter.
More products are being applied for domestic first-class medical devices and the US FDA DMF registration. Welcome to call or write to us for consultation. National unified customer service telephone 010-88681766.
With the development of global life sciences and technology, CAR-T cell drugs are on the market, and more innovative theories, technologies and clinical researches of cell therapy continue to emerge. my country's cell therapy industry is in a good period of development, and supervision has become a driving force for its industry. An indispensable link in the development of globalization. In recent years, the National Health Commission and the State Food and Drug Administration have successively issued a series of policies to regulate and supervise. However, there are no clear and detailed regulations and explanations on the regulatory bodies and review standards for the clinical research and clinical application of cell therapy. Whether referring to the dual-track system in Europe, America or Japan, my country's cell therapy industry will surely explore a development route that is more suitable for my country's national conditions.
Future policies and industry trends still pose huge challenges to the raw material market. Tongli Haiyuan Bio will continue to improve product quality, continuously improve product qualifications, continuously improve service levels, and actively participate in customer cell drug research and development to help the development of the cell therapy industry.
From April 9th ??to 10th, 2021, Beijing Tongli Haiyuan Bio will appear at the BPIT 2021 Biopharmaceutical Innovation Technology Conference hosted by Yimike. We look forward to your visit. Booth No.: B36 Crowne Plaza Shanghai Jiangong Pujiang