As the life sciences, medtech, and diagnostic industries continue to expand and grow increasingly complex, so does the legal, regulatory, and compliance landscape. To help companies and investors navigate the many evolving...more
The UK Medicines and Healthcare products Regulatory Agency (MHRA) has announced the introduction of new international recognitions routes for the approval of medicines that are already authorised in Australia, Canada, the...more
The life science industry is a significant contributor to the global market, with companies developing and manufacturing a wide range of medical products and devices. However, due to the complex and highly regulated processes...more
STADA and Xbrane Announce Approval of Ranibizumab Biosimilar in UK - On January 16, 2023, STADA Arzneimittel AG (STADA) and Xbrane Biopharyma AB (Xbrane) announced that the UK’s Medicines and Healthcare product Regulatory...more
On November 17, 2022, Senator Mike Lee (R-UT) introduced the “Biosimilar Red Tape Elimination Act” to increase biosimilar competition and reduce patient costs by prohibiting the FDA from requiring switching studies to approve...more
The UK Medicines and Healthcare products Regulatory Agency (MHRA) has initiated a consultation on the legislation and regulatory processes for medicines, medical devices and related clinical trials that would need to be...more
The UK House of Commons Health and Social Care Committee has published the findings of its six-month long investigation into the impact of Brexit on medicines, medical devices and substances of human origin. ...more
On the same day as the European Council voted to move the European Medicines Agency (EMA) from London to Amsterdam, the UK Parliament issued a briefing paper on Brexit and medicines regulation. ...more
With the negotiations for the UK’s withdrawal from the EU formally under way, the UK healthcare sector is calling on the UK Government to make patient safety and access to medicines a priority in negotiations – and it appears...more
The Medicines and Healthcare products Regulatory Agency (MHRA), the UK's pharmaceutical and medical devices regulator, has recently released its 2017-2018 business plan. Of the 10 key priorities identified by the MHRA, life...more