One challenge to getting acclimated with the drug approval process is learning the language—especially the long list of acronyms, abbreviations, and unique terms that industry insiders use. As experienced advisors in this space, we at Pearl Pathways want to help those new to drug development and regulatory filings navigate this regulatory “alphabet soup” by defining a few essential terms related to the regulation and approval of drugs and biologics.
ANDA
ANDA stands for “Abbreviated New Drug Application.” It pertains to a request for FDA review and approval of a generic drug as a safe, effective, lower-cost alternative to a brand-name drug already in the market.
BLA
BLA stands for “Biologics License Application,” a request for permission to introduce, or deliver for introduction, a biologic product into interstate commerce. As such, it is equivalent to an NDA filing for a new drug.
CTA
CTA stands for “Clinical Trial Application,” a submission to the National Regulatory Authority(ies) for authorization to conduct a clinical trial in a specific country.
CTD
CTD stands for “Common Technical Document,” an internationally agreed upon format required by regulatory authorities for well-structured dossier applications for registration of new drugs.
DMF/eDMF
DMF or eDMF stands for “Drug Master File” or “Electronic Drug Master File.” In either case, it is a submission to FDA that is used to provide detailed, confidential information about facilities, processes, or articles used to manufacture, process, package, and/or store drugs.
eCTD
eCTD stands for “Electronic Common Technical Document,” the standard format for electronically submitting applications, amendments, supplements, and reports to regulatory agencies in several countries, including the US (FDA), Europe (EMA), Japan (PMDA), Canada (Health Canada), and China (NMPA).
IMPD
IMPD stands for “Investigational Medicinal Product Dossier,” one of several pieces of data required when a sponsor proposes a clinical trial of an Investigational Medicinal Product (IMP) in a European Union Member State.
IND
IND stands for “Investigational New Drug Application.” This application is a request for FDA authorization to administer an investigational drug or biological product to human beings. The primary purpose of an IND submission is to ensure the safety and protect the rights of clinical trial participants.
MAA
MAA stands for “Marketing Authorisation Application,” an application submitted to the European Medicines Agency (EMA) by a drug manufacturer seeking permission to bring a medicinal product to market.
NDA
NDA stands for “New Drug Application.” Through an NDA, sponsors formally propose that the FDA approve a new drug for marketing and sale in the USA. The NDA should provide enough evidence to support the safety and effectiveness of the drug.
NMPA
NMPA stands for “National Medical Products Administration,” the main regulatory authority responsible for drug registration, review, and approval in China.
PMDA and MHLW
PMDA stands for “Pharmaceuticals and Medical Devices Agency,” while MHLW stands for “Ministry of Health, Labour, and Welfare.” The two are the regulatory bodies that review and approve drugs and medical devices in Japan.
In our next post, we’ll focus on a few terms that have to do with the regulation and approval of devices.
Need to know more about the terms, the processes they reference, or anything associated with completing regulatory filings or communicating with FDA and other regulatory authorities? We at Pearl Pathways are ready to help. Reach out to us any time.