Welcome to the new and improved RAPS Regipedia!

Acronyms & Definitions

Influence Your Community
This valuable resource was created for regulatory professionals by regulatory professionals and we encourage you to participate by sharing your vast knowledge. You have the opportunity to suggest new terms, definitions, or acronyms or to edit existing entries. You keep Regipedia current. The regulatory community benefits.

Expand Your Knowledge
Developed exclusively for RAPS members, Regipedia is a growing collection of more than 2,300 regulatory terms, definitions and acronyms. Individual terms are cross-referenced by region and sector and many include additional access to current sources and references. Regipedia is your direct entry into today’s most relevant and timely global regulatory knowledge base. Log into your account today and see how Regipedia can help expand and enhance your knowledge of the regulatory landscape.

Log into your account today and help RAPS continue to expand and improve Regipedia. Submissions will be vetted by RAPS editorial team, and notification of approval or revision will be made expediently. If you are not a member, join RAPS today and start contributing to and benefitting from this important regulatory resource. 

In order to access Regipedia you need to be a RAPS member. To become a RAPS member, click here. Login if you are already a member.
Displaying 1 - 10 of 2214
Items per Page
  • Protects an ANDA applicant from competition from subsequent generic versions of the same drug product for 180 days.

    Read More
  • 505(b)(2)

    NDA for a drug product for which one or more of the investigations relied upon by the applicant were not conducted by or for the application, and for which the applicant does not have the right of reference or use from the person conducting the investigation.

    Read More
  • 510(k)

    Premarket notification submission based on medical device being substantially equivalent to a product already on the market.

    Read More
  • ANADA

    Shortened version of New Animal Drug Application (NADA) that may be submitted for approval of a new formulation of an existing animal drug that is similar to an already approved drug (used for generic animal drug products).

    Read More
  • ANDA

    Shortened version of New Drug Application (NDA) that may be submitted for approval of a new formulation of an existing drug or investigational drugs that are similar to already approved drugs (used for generic drug products). Also called 505(j) pathway.

    Read More
  • ANDS

    A submission for a new drug where, in comparison with a Canadian Reference Product (CRP), the new drug is the pharmaceutical equivalent; is bioequivalent based on the pharmaceutical and, where the minister considers it necessary, bioavailability characteristics; has the same route of administration; and has conditions of use that fall within the CRP�s conditions of use.

    Read More
  • An application for marketing authorisation that, based upon demonstrating essential similarity, does not contain the results of pharmacological and toxicological tests of the results of clinical trials.

    Read More
Displaying 1 - 10 of 2214
Items per Page
Publications
  • Regulatory Writing is an invaluable resource for any professional engaged in designing, composing, compiling, or commenting on regulatory documentation.

  • This compilation includes the individual medical device subsets from all four Fundamentals of Regulatory Affairs books: US, EU, Canada and International. The subsets cover the entire medical device lifecycle, from product development through postmarketing for all these regions.

  • The second edition of Global Medical Device Regulatory Strategy includes timely updates on all chapters, current information on cybersecurity and software, new international regulations and a new chapter on driving successful commercial product launches.

Contact Us
Regulatory Affairs Professionals Society (RAPS)
P: +1 301-770-2920 x200
5635 Fishers Lane, Suite 400 | Rockville, Maryland 20852