First, the FDA factory registration
1. Introduction to factory registration
According to the US Federal Food and Drug Administration Regulations and US federal regulations, any company engaged in pharmaceutical production and packaging activities must register its production address and products with the FDA. This requirement applies equally to US domestic companies and overseas companies.
For overseas companies, factory registration and product registration are among the important regulatory measures of the US FDA for imported drugs. The FDA can find the detailed information of the relevant company through the registration number, and can contact the agent of the relevant company in the United States in time to effectively grasp the information of the relevant enterprise products in the United States.
Since June 1, 2009, the FDA no longer accepts paper factory registration and product registration, but is registered electronically.
2. The basic process of factory registration
(1) Obtain an ESG account
ESG's full name is the Electronic Submission Gateway, which is the path for electronic delivery. ESG is a prerequisite for submitting factory registrations and drug registrations.
(2) Apply for DUNS number
The DUNS number, often translated as "Deng's Global Code" or "Deng Baishi Global Code", is an identifier of a business entity or organization. The DUNS number is a unique 9-digit code that is used by global companies to identify, organize, and link standards for family-owned organizations around the world. It is a reference for companies and organizations around the world to assess business opportunities and risks.
(3) Preparation and submission of documents
SPL (Structured Product Labeling) is the standard used by the FDA for factory registration and drug registration. SPL files are written in the extensible markup language (XML) language to increase the standardization of information. Registration forms using standardized SPL files can be automatically identified by the FDA database for timely and efficient updates to the factory registration and product registration database.
Second, the FDA factory self-identification
1, the background
FDA Factory Self-identification is a generic drug manufacturer based on the relevant requirements of the FDA's Generic Drug User Fee Amendments of 2012 (GDUFA). A factory filing and charging project implemented.
GDUFA aims to speed up the approval process for generic drugs and provide users with safe and effective generics more efficiently. GDUFA requires the pharmaceutical company to bear the costs incurred in the generic drug review and on-site inspection. These costs will help the FDA reduce the time required for application review and application review, reduce the average cycle of drug reviews, and increase on-site audits based on risk assessment.
2, applicable objects
In the generic drug application being reviewed and the approved generic drug, the production site (including the drug substance and the preparation) involved shall be self-identified by the factory and paid the factory self-identified fee.
3. Payment time
For the fiscal year 2013 (from October 1, 2012 to September 30, 2013), the factory self-certified expenses must be paid before March 4, 2013. For the fiscal year 2014~2017, the fee will be paid on or after October 1 of each fiscal year.
In FY2013, for non-US domestic factories, the self-identified fee was US$41,458, which was calculated from the average amount to the total number of factories that have been self-identified.
Conley Consulting believes that there will be a certain reduction in the amount of fees determined by the factory in FY2014, but since the total FDA is still counting (the statistical period is from May 2013 to June 2013), the final amount has not yet been determined.
4. Consequences of not paying on time:
Failure to pay the factory’s self-identified fees in a timely manner will have several consequences. First, generic applications that reference the site cannot be approved. In addition, sites that fail to pay on time will be uniformly posted to the arrears list; FDA will also notify ANDA applicants; in addition, any API or formulation produced at the site will be identified by the FDA as “misbranded” "This means that exporting the product to the United States will be illegal by the US Customs and will refuse entry."
5. Self-identified information to be submitted
The FDA factory determines the basic information that needs to be submitted to the factory, such as the factory name, address, contact information, contact information, FEI registration number, DUNS registration number, etc. This information needs to be completed in the FDA-specified SPL form and submitted through the FDA electronic pathway. Upon completion of the submission, the system automatically verifies the accuracy of the form and is updated by the FDA to the GDUFA database.
Third, NDC registration
1. What is the NDC and NDC system?
NDC (National Drug Code) is a recognition symbol for drugs as a general commodity. The NDC database is open for public inspection and includes all prescription and over-the-counter drugs, but does not include veterinary drugs, blood products, and non-finalized drugs (such as API).
2. US FDA's management of NDC
Any drug must be registered with the NDC number before it is listed in the US. The main information registered includes the name of the drug, the manufacturer, the drug classification, the route of administration, the date of listing, the OTC monograph number and label. Drugs with the NDC number can be listed in the US on the basis of FDA-related drug management laws. Vendors and end users can check the relevant efficacy and characteristics of the product according to this number, and the FDA also manages the product according to this number.
NDC is only a registration system for drug information. Products registered in the NDC database do not mean that the drug is approved by the FDA or can be sold as a drug, nor does it mean that the product can be reimbursed or paid for by other organizations.
FDA regulations require changes to be made at any time during the June and December of each year when the registration system is updated or changed.
3. Significance of Chinese pharmaceutical companies for NDC registration
NDC registration is a fast application form for Chinese non-prescription drugs to pass FDA certification. For drugs contained in the OTC monograph, no approval is required before listing in the US, and only necessary information for NDC registration is required in accordance with relevant requirements. Traditional Chinese medicines and non-prescription drugs registered through NDC can be sold in Chinese and Western pharmacies.
Therefore, NDC registration is a good way for Chinese medicine and non-prescription drugs to enter the United States.
Fourth, our service
According to the latest US FDA requirements for electronic registration and electronic filing, Conley Consulting provides services related to FDA electronic registration and electronic filing.
The business services include: agent D&B code application for customer enterprise; agent factory electronic registration (FEI registration), agent NDC electronic registration and maintenance, and agent DMF file electronic submission and maintenance.