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As we all are aware, the United States Food and Drug Administration’s (US FDA’s) electronic Common Technical Document (eCTD) requirement is nearing the deadline. Another couple of months to go; by May 5, 2017, all pharmaceutical, biologic and generic manufacturers must submit application types New Drug Applications (NDAs), Biologics License Application (BLAs) and Abbreviated New Drug Applications (ANDAs) to the US Food and Drug Administration (FDA) using the electronic Common Technical Document (eCTD) format only.
As directed by the FDA in its eCTD guidance, all new DMFs (Drug Master Files), as well as all documents submitted to existing DMFs, must be submitted in an electronic format (eCTD) beginning May 5, 2017. The DMF submissions that are not submitted in eCTD format after this assigned date will be thereby rejected. However, the DMF holders whose DMFs are currently in paper form will not be required to resubmit their entire DMF in eCTD format, after May 5, 2017.
With that informed, what exactly manufacturers should know about various application types that need end-to-end eCTD conversion for successful compliance? Let’s take a quick look at the different application types that need to be submitted in the electronic format.
Application Types that need eCTD Conversion:
- New Drug Applications (NDA): An NDA application is the source through which drug sponsors across the globe formally approach the FDA to approve any new pharmaceutical for sale and marketing in the US market. All data gathered during animal studies and human clinical trials of an Investigational New Drug (IND) eventually become part of the NDA as well. The documentation required in an NDA encompasses the drug’s entire story, right from the ingredients used, clinical test reports, animal study results, how exactly does the drug behave in the body, and how it is manufactured, processed and packaged.
- Abbreviated New Drug Applications (ANDA): An ANDA application consists of data pertaining to the review and final approval of a generic drug product. Once approved by the US FDA, an applicant may manufacture and market the concerned generic drug and in turn provide a safe, effective and cheap alternative to the public. These generic drug applications are termed “abbreviated” because they are generally not required to submit preclinical and clinical data to establish the safety and efficacy factors. A generic drug product is compared to an innovator drug in terms of dosage, strength, route of administration, quality, performance characteristics and intended use. So, it will suffice if a generic applicant scientifically demonstrates that his product is bioequivalent, i.e., performs in the same manner as the innovator drug.
- Biologics License Application (BLA): A BLA as defined by the US FDA, is a request for permission to introduce, or deliver for introduction, a biologic product into interstate commerce. A BLA is submitted by any legal person or entity who is engaged in biologics manufacturing or an applicant for a license who takes responsibility for compliance with product and establishment standards. It comprises of applicant details, product/ manufacturing information, pre-clinical and clinical study reports and labeling details. A BLA is submitted after an investigational new drug (IND) has been approved, asserting that the concerned product is “safe, pure, and potent”, the manufacturing facilities are audit-ready, and each package of the product bears the license number.
- Drug Master Files (DMFs): A DMF application is a confidential, detailed document submitted by a pharmaceutical manufacturer to the US FDA. It mainly contains detailed information about facilities, processes, or ingredients used in the manufacturing, processing, packaging, and storing a concerned drug. According to the FDA, a DMF application is neither approved nor disapproved, but its information is used to review an IND, NDA, ANDA, or an Export Application.
Now that the eCTD conversion deadline approaches, it’s time all pharmaceutical, biologic and generic manufacturers across the globe aiming at the US market must convert the required applications in the eCTD format way ahead of time and prevent any last-minute confusion. However, legacy eCTD conversion tools might hinder organizations’ compliance efforts. Take advantage of a publishing and submissions, and an eCTD conversion expert.
