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  2. List of Guidances for Statistics in Regulatory Affairs

    en.wikipedia.org/wiki/List_of_Guidances_for...

    EMA/199678/2016: Reflection paper on extrapolation of efficacy and safety in paediatric medicine development. [8] EMA/189724/2018: Reflection paper on the use of extrapolation in the development of medicines for paediatrics. [9] EMA/129698/2012: Concept paper on extrapolation of efficacy and safety in medicine development. [10]

  3. Electronic common technical document - Wikipedia

    en.wikipedia.org/wiki/Electronic_Common...

    The electronic common technical document (eCTD) is an interface and international specification for the pharmaceutical industry to agency transfer of regulatory information. The specification is based on the Common Technical Document (CTD) format and was developed by the International Council for Harmonisation (ICH) Multidisciplinary Group 2 ...

  4. Common Technical Document - Wikipedia

    en.wikipedia.org/wiki/Common_Technical_Document

    The Common Technical Document (CTD) is a set of specifications for an application dossier for the registration of medicine, designed for use across Europe, Japan, the United States, and beyond. [ 1 ] Major Synopsis

  5. Trial master file - Wikipedia

    en.wikipedia.org/wiki/Trial_master_file

    The minimum essential documents that are required for the registration of pharmaceutical products designed for human use are specified in the document 'ICH Good Clinical Practices,' published in 1997 by the ICH [2] Example ICH essential documents that would be required in any US, EU or Japan based clinical trial would include: signed protocol ...

  6. EudraLex - Wikipedia

    en.wikipedia.org/wiki/EudraLex

    Download QR code; Print/export Download as PDF; Printable version; In other projects Wikidata item; Appearance. ... Free Trade Agreements; European Single Market.

  7. European Medicines Agency - Wikipedia

    en.wikipedia.org/wiki/European_Medicines_Agency

    The European Medicines Agency (EMA) operates as a decentralised scientific agency (as opposed to a regulatory authority) of the European Union (EU) and its main responsibility is the protection and promotion of public and animal health, through the evaluation and supervision of medicines for human and veterinary use. [8]

  8. Investigator's brochure - Wikipedia

    en.wikipedia.org/wiki/Investigator's_brochure

    In drug development and medical device development [1] the Investigator's Brochure (IB) is a comprehensive document summarizing the body of information about an investigational product ("IP" or "study drug") obtained during a drug trial. The IB is a document of critical importance throughout the drug development process and is updated with new ...

  9. Marketing authorisation - Wikipedia

    en.wikipedia.org/wiki/Marketing_authorisation

    Depending on jurisdiction, the resulting document may be more detailed (in addition to data identifying the product and its marketing authorisation holder), for example containing addresses of all manufacturing sites, appended labelling, artwork of packaging components, etc. or may be simplified to a one-page document called certificate of ...

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