New Drug Application
The New Drug Application (NDA) is the application for drug approval from the US Food and Drug Safety Authority ( FDA ), which drug manufacturers must submit in order to obtain marketing approval. Official drug approval is required in order to be able to offer, sell or dispense an industrially manufactured, ready-to-use drug. The aim of an NDA application is to provide the FDA with sufficient information to assess the following questions:
- If used as intended, is the drug safe and effective and do the pharmaceutical benefits outweigh the risks?
- Are the instructions for use ( package insert ) and the package label of sufficient quality?
- Are the manufacturing methods used ( Good Manufacturing Practice , GMP) and the controls used to control the drug suitable to ensure identity, strength, quality and purity?
Investigational new drug application
In order to obtain official approval for testing a drug on humans ( clinical studies ), the applicant must first submit a so-called "Investigational New Drug" (IND) application to the FDA. This application is based on pre-clinical data , typically collected from animal experiments , which show that the drug is sufficiently safe to be tested in humans.
The NDA application
The results of the drug tests are recorded in an FDA-approved document, the information for use . The instructions for use are published on the Internet by the FDA and the drug manufacturers and are enclosed with the drug as a package insert. The background to this measure is to provide the healthcare system and patients with adequate information and instructions for the correct use of a medicinal product.
The documentation required for an NDA application includes all information about a drug. The results of the preclinical and clinical studies, the formulation , the pharmacology and a detailed description of the manufacturing process are important components of the document. After approval of an NDA, i. H. Once approved, the drug can be placed on the US market.
Once the application has been submitted to the FDA, the FDA has 60 days to prepare a preliminary review that shows whether the application has all of the required documentation for further scrutiny. If this is not the case (reasons for this range from simple administrative errors to the lack of study data), the FDA rejects the application with a so-called "Refuse to file" message, which tells the applicant which components of the NDA are not included met the required conditions.
Assuming that the NDA application contains all the necessary information, this is also communicated to the applicant ("74-day letter") and the FDA has 10 months to examine the NDA application more closely and finally to decide whether to approve it is granted. In the case of an accelerated process ("fast-track"), which can be used primarily for products with particularly important therapeutic benefits, this time is only approx. 6 months.
Of the 131 NDA applications submitted in 2009, 94 were submitted in electronic form, in the so-called eCTD format.
Applications for organic and generic products
For biopharmaceuticals such as B. vaccines or recombinant proteins , a so-called "biological license application" (BLA) is provided instead of an NDA. Since the production of biological drugs differs fundamentally from the production of chemically synthesized pharmaceuticals, a modified approval process is necessary.
For generics whose originator products have already been approved via an NDA application, a so-called "abbreviated new drug application" (ANDA) is submitted. With this type of application, the required information on preclinical and clinical studies is not as detailed as with an NDA. In this case, it is sufficient if the applicant can scientifically prove that the generic and the originator product are essentially the same ("essentially similar"). This can u. a. are proven by so-called bioavailability studies.