The FDA requires manufacturers to record product and equipment information, and provide the regulatory files to the FDA, in order to access and review in the future as reference. According to the latest rules in May 2017, in order to simplify and modernize drug approval process, all data should be submitted in a unified standardized electronic format (eCTD) to submit.
All production expected for disease diagnosis, treatment, relief symptoms, treatment or prevention of disease that has pharmacological activity or other direct effect, or can affect the body's function and structure of pharmaceutical factories need FDA registration and declaration of all of its components. All non-U.S. factories that export drugs to the United States must register their factories with the FDA and declare their products. The FDA requires manufacturers, packers and dealers to register for non-prescription drugs (such as hands-free lotion, sunscreen products, fluoride toothpaste, etc.).
Our services include the following:
1. FDA application of new drugs and generic drugs
New Drug Application (NDA)
When the applicant has enough reasons to prove that the safety and efficacy of drug meets the requirement of FDA to release into the market, the applicant can be ready to submit the NDA to FDA. Before all the drugs going to the market, they must pass the new drug review process. The materials which need to be submitted include chemistry, pharmacology, biological reagents and statistical reviews,etc. If NDA is approved, the drug can go to the US market directly. In addition, in order to facilitate the internal tracking, all of the NDA application will have a NDA number. General NDA review and IND is reviewed by the same accreditation review group, but the NDA will no doubt be more time-consuming.
Abbreviated New Drug Application (ANDA)
Abbreviated new drug application does not need to provide preclinical (animal) and clinical (human) data to prove their safety and effectiveness. Instead, the applicants must provide proof of product bioequivalence materials. Bioequivalence data regulation requires that the bioequivalence data report shall be complete and complied with the application regulation. The relevant research materials submitted for the same formulation materials, should include data both in vivo and in vitro, and data of the bioequivalence study. Once such a drug has been approved, the applicant can manufacture the safe, effective and inexpensive alternatives and release the products into the market.
2. Medical equipment 510k submission
510k is the certificate which should be submitted to the FDA at least 90 days prior to the medical devices to be put into commercial. It is to prove that the device equals the legitimate instrument in United States market, as safe and effective. This is the official announcement before launching. First time launching, making a significant change from the existing equipment, and equipment that is different for intended use must apply for 510k.
June 25, 2014, Eastern Time, the United States Food and Drug Administration released Global Unique Device Identification Database Guidelines. The unique identifier of the device, which satisfies the requirements of CFR part 830.20, is used to fully identify a device through its distribution and use. UDI, Unique Device Identifier, is a kind of Numbers or letters encoding, consisted of two parts, device identifier (DI) and production identifier (PI). DI can identify specific instrument version or model, at the same time it can identify the equipment labeler. PI is used to identify the following 4 kinds of circumstances:
A. Batch of equipment manufacturing;
B. The serial number of the equipment;
C. Expire date of equipment;
D. Date of equipment manufacturing.
The FDA requires devices need to display UDI on itself and the packaging. During medical device adverse events, UDI helps to report, review and analyze the reason. It provides information and help reduce errors. By providing standard and clear ways to record the use of devices in electronic health records, clinical information systems, data sources and registration requirements, we can strengthen the analysis of instruments on the market.
In order to fully implement UDI, FDA establishes GUDID for each instrument with UDI. GUDID will open most data to the public, so that the equipment users can easily have access to the information of equipment. Also because of this, FDA issued the GUDID so as to guide users how to submit information to GUDID.
3. Drug Master Files preparation, drug packaging materials and drug excipients FDA submission
Drug Master Files is a confidential document submitted to the FDA. It provides the raw materials and active intermediates for the production of drugs and its facilities, process, packing, warehousing and other related information.
The main types are:
Type I, manufacturing sites and facilities, personnel (cancelled);
Type II, intermediates, active pharmaceutical ingredients and drug;
Type III, packaging materials;
Type IV, excipients, colorants, flavors and fragrances, and other additives;
Type V, the non-clinical data and clinical data.
Although the FDA does not specify in formal documentation that the manufacturer must report DMF information of the exported products to the United States. If the product is used as a prescription drug, the United States FDA would definitely inspect the manufacturer to determine if the production is consistent with the reported data or not, in accordance with the US CGMP (current GMP). The DMF file library in the United States is a supplier resource base widely used by pharmaceutical manufacturers around the world, so almost all pharmaceutical factories that want to bring products to the international market are registered with DMF. DMF registration has the following advantages:
1) Simplifies the factory application content. DMF record number directly replace the units of specific data of preparation of the application materials, reduced the risk of enterprise leaking technical secret caused by providing too many information to agents;
2) The enterprise and its products that obtain the DMF record number will be publicized on the FDA website. With the DMF record number issued by the FDA, company can attract more pharmaceutical customers to build cooperative relationship, and gain the competitive advantage in the market;
We can assist enterprise to prepare DMF files, submit DMF in e-CTD format through the ESG channel so that the customer could get DMF number quickly.