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  2. European Medicines Agency - Wikipedia

    en.wikipedia.org/wiki/European_Medicines_Agency

    As of 2016, the EMA was roughly parallel to the drug part of the U.S. Food and Drug Administration (FDA), [53] but without centralisation. [54] The timetable for product approval via the EMA's centralised procedure of 210 days compares well with the average of 500 days taken by the FDA in 2008 to evaluate a product. [55]

  3. Good clinical practice - Wikipedia

    en.wikipedia.org/wiki/Good_clinical_practice

    European Union: In the EU, Good Clinical Practice is backed and regulated by formal legislation contained in the Clinical Trial Regulation (Officially Regulation (EU) No 536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC). [3]

  4. Clinical Trials Directive - Wikipedia

    en.wikipedia.org/wiki/Clinical_Trials_Directive

    The Clinical Trials Directive (Officially Directive 2001/20/EC of 4 April 2001, of the European Parliament and of the Council on the approximation of the laws, regulations and administrative provisions of the Member States relating to implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use) is a European Union directive that aimed at ...

  5. EudraLex - Wikipedia

    en.wikipedia.org/wiki/EudraLex

    Vol. 1: Pharmaceutical legislation: medicinal products for human use. ISBN 92-828-2032-7; Vol. 2: Notice to applicants: medicinal products for human use. ISBN 0-11-975780-X; Vol. 3: Guidelines: medicinal products for human use. ISBN 92-828-2436-5; Vol. 4: Good manufacturing practices: medicinal products for human and veterinary use. ISBN 92-828 ...

  6. Pharmaceutical Inspection Convention and Pharmaceutical ...

    en.wikipedia.org/wiki/Pharmaceutical_Inspection...

    [1] [2] The initial members comprised the 10 member countries of EFTA at that time. In the early 1990s it was realized that because of an incompatibility between the Convention and European law, it was not possible for new countries to be admitted as members of PIC. European law did not permit individual EU countries that were members of PIC to ...

  7. Trial master file - Wikipedia

    en.wikipedia.org/wiki/Trial_master_file

    The first version of the TMF Reference Model (TMF RM) [5] was released in June 2010 and was updated in February, 2011 (v1.1) based on feedback provided by Regulators, and again in December, 2011 (v1.2), based on feedback provided by users of the model as they used it within their respective organizations to structure their paper and electronic ...

  8. US FDA warns online vendors selling unapproved weight ... - AOL

    www.aol.com/news/us-fda-warns-online-vendors...

    The agency also sent a warning letter to Veronvy, which offers unapproved and misbranded oral GLP-1 products, including one that claims to be approved by the FDA. US FDA warns online vendors ...

  9. Electronic trial master file - Wikipedia

    en.wikipedia.org/wiki/Electronic_trial_master_file

    An electronic trial master file (eTMF) is a trial master file in electronic (digital content) format.It is a type of content management system for the pharmaceutical industry, providing a formalized means of organizing and storing documents, images, and other digital content for pharmaceutical clinical trials that may be required for compliance with government regulatory agencies.

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