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  2. Medicines and Healthcare products Regulatory Agency

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

    The regulator's public assessment report for the vaccine was published in 15 December. [27] The MHRA went on to give conditional and temporary authorization to supply of further vaccines: AZD1222 from Oxford University and AstraZeneca on 30 December, [28] mRNA-1273 from Moderna on 8 January 2021, [29] and a single-dose vaccine from Janssen on ...

  3. Qualified Person Responsible For Pharmacovigilance - Wikipedia

    en.wikipedia.org/wiki/Qualified_Person...

    The QPPV must reside in the EU, and should be permanently and continuously at the disposal of the MAH. Each company (i.e. Applicant/Marketing Authorisation Holder or group of Marketing Authorisation Holders using a common pharmacovigilance system) should appoint one QPPV responsible for overall pharmacovigilance for all medicinal products for which the company holds marketing authorisations ...

  4. Pharmacovigilance - Wikipedia

    en.wikipedia.org/wiki/Pharmacovigilance

    Worldwide, the most important aggregate report is the Periodic Safety Update Report (PSUR) and Development Safety Update Report (DSUR). This is a document that is submitted to drug regulatory agencies in Europe, the US and Japan (ICH countries), as well as other countries around the world.

  5. Yellow Card Scheme - Wikipedia

    en.wikipedia.org/wiki/Yellow_Card_Scheme

    It is run by the Medicines and Healthcare products Regulatory Agency (MHRA) and the Commission on Human Medicines. It was extended to hospital pharmacists in 1997, and to community pharmacists in 1999. [2] The Yellow Card Centre Scotland is a joint venture between MHRA and the Scottish Government. [3]

  6. Postmarketing surveillance - Wikipedia

    en.wikipedia.org/wiki/Postmarketing_surveillance

    Postmarketing surveillance is overseen by the Food and Drug Administration (FDA), which operates a system of passive surveillance called MedWatch, to which doctors or the general public can voluntarily report adverse reactions to drugs and medical devices. [7] The FDA also conducts active surveillance of certain regulated products.

  7. List of stringent regulatory authorities - Wikipedia

    en.wikipedia.org/wiki/List_of_stringent...

    A stringent regulatory authority is a regulatory authority which is: a) a member of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), being the European Commission, the US Food and Drug Administration and the Ministry of Health, Labour and Welfare of Japan also represented by the Pharmaceuticals and Medical Devices Agency (as before ...

  8. Regulation of therapeutic goods - Wikipedia

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

    The role of therapeutic goods regulation is designed mainly to protect the health and safety of the population. Regulation is aimed at ensuring the safety, quality, and efficacy of the therapeutic goods which are covered under the scope of the regulation. In most jurisdictions, therapeutic goods must be registered before they are allowed to be ...

  9. Drug Quality and Security Act - Wikipedia

    en.wikipedia.org/wiki/Drug_Quality_and_Security_Act

    Drug products compounded by or under the direct supervision of a licensed pharmacist at an outsourcing facility may be able to qualify for exemptions from the following three sections of the FD&C Act: (1) section 505 (concerning FDA approval of drugs); (2) section 502(f)(1) (concerning the labeling of drug products with adequate directions for ...