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GxP News

  • Access, new active substance and biosimilar work sharing initiatives

    Information on applying for New Active Substance Work Sharing Initiative (NASWSI) and Biosimilar Work Sharing Initiative (BSWSI) assessments and list of approved products.

  • MHRA launches new digital hub in Leeds to drive innovation and regional growth

    The new hub will strengthen the MHRA’s work with regional partners and boost the UK’s digital health and life sciences sector.

  • Decision: Orphan registered medicinal products

    A list of authorised orphan medicinal products registered by the UK licensing authority.

  • Field Safety Notices: 19 to 23 May 2025

    List of Field Safety Notices from 19 to 23 May 2025.

  • MHRA launches new digital hub in Leeds to drive innovation and regional growth

    The new hub will strengthen the MHRA’s work with regional partners and boost the UK’s digital health and life sciences sector.

  • Decision: Human and veterinary medicines: register of licensed wholesale distribution sites

    Department of Health and Social Care and MHRA register of licensed wholesale distribution sites (human and veterinary).

  • Decision: Medicines: new manufacturing and wholesale dealer licences

    List of sites granted a manufacturer or wholesale dealer licence.

  • Decision: Human and veterinary medicines: register of licensed manufacturing sites

    The MHRA register of licensed manufacturing sites: manufacturer specials - human (MS) and manufacturer specials authorisation - veterinary (MANSA) only.

  • Notice: Medicines: terminated and cancelled manufacturing and wholesale dealer licences

    UK companies who have their licence to manufacture or wholesale medicines terminated and cancelled.

  • Women on “skinny jabs” must use effective contraception, MHRA urges in latest guidance 

    Anyone who suspects that they’ve had an adverse reaction to their weight loss or diabetes medicine or suspects it is not a genuine product, should report it to the MHRA.