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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. Medicines and Healthcare products Regulatory Agency

    en.wikipedia.org/wiki/Medicines_and_Healthcare...

    In 2005, the MHRA was criticised by the House of Commons Health Committee for, among other things, lacking transparency, [41] and for inadequately checking drug licensing data. [42] The MHRA and the US Food and Drug Administration were criticised in the 2012 book Bad Pharma, [43] and in 2004 by David Healy in evidence to the House of Commons ...

  4. European Directorate for the Quality of Medicines & HealthCare

    en.wikipedia.org/wiki/European_Directorate_for...

    As previously stated, a CEP [18] is granted after members of the EDQM's panel of assessors (drawn from national medicines agencies throughout Europe) have reviewed a detailed dossier submitted by the manufacturer. This dossier describes the manufacturing process and the tests performed on the raw materials and on the substance produced, as well ...

  5. Regulation of therapeutic goods - Wikipedia

    en.wikipedia.org/wiki/Regulation_of_therapeutic...

    The European Union (EU) medicines regulatory system is based on a network of around 50 regulatory authorities from the 31 EEA countries (28 EU Member States plus Iceland, Liechtenstein and Norway), the European Commission and European Medicines Agency (EMA). EMA and the Member States cooperate and share expertise in the assessment of new ...

  6. EU drug watchdog to consider wider use of Wegovy weight ... - AOL

    www.aol.com/news/eu-drug-watchdog-review-wider...

    FRANKFURT (Reuters) -The European Union's drug regulator will this week consider wider use of Novo Nordisk's weight-loss drug Wegovy to include reducing the risk of strokes and heart attacks.

  7. Product Licence Number - Wikipedia

    en.wikipedia.org/wiki/Product_Licence_Number

    A Product Licence Number (or PL code for short) is a unique identifier on the packaging of medicines, used to uniquely identify the product. This code will normally remain the same despite the varying marketing and branding of the companies selling it.

  8. Test panel - Wikipedia

    en.wikipedia.org/wiki/Test_panel

    A test panel is a predetermined group of medical tests used in the diagnosis and treatment of disease.. Test panels (sometimes called profiles) are typically composed of individual laboratory tests which are related in some way: by the medical condition they are intended to help diagnose (cardiac risk panel), by the specimen type (complete blood count, CBC), by the tests most frequently ...

  9. Postmarketing surveillance - Wikipedia

    en.wikipedia.org/wiki/Postmarketing_surveillance

    Postmarketing surveillance (PMS), also known as post market surveillance, is the practice of monitoring the safety of a pharmaceutical drug or medical device after it has been released on the market and is an important part of the science of pharmacovigilance.

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