Special approval procedures for new drugs and biosimilars, more use of real-world data, a streamlined drug safety monitoring system, and a ‘patient-first culture.’ The MHRA has plenty of ideas in store for its post-Brexit life as a fully independent regulator from January next year.
The UK regulator, the MHRA, is to introduce a new accelerated licensing procedure for innovative medicines from the beginning of 2021, when it is due to assume full responsibility for marketing authorizations and related regulatory activities as a result of the country's departure from the EU.
The agency will have a closer focus on patient access to highly innovative products, and more use will be made...
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The UK Health Research Authority’s latest three-year strategy sets ambitious targets to make research more transparent. One World Health Organization official believes the authority can go further by setting equally high standards for the timely reporting of clinical trial results.
The Association of the British Pharmaceutical Industry says that while the government’s newly published Life Sciences Sector Plan includes many positive commitments, they are not enough.
Vertex said it reached “a broad reimbursement agreement” with the National Health Service for its once-daily, triple combination treatment for cystic fibrosis. As for reimbursement in the rest of Europe, the company is targeting Ireland, Denmark and Germany next.
The Health Research Authority is working on a streamlined model for informed consent that maintains people’s trust.
Nearshoring production and diversifying contract manufacturing networks can help companies stave off cost increases that will be reflected in higher medicine prices.
Eli Lilly and PharmaMar were set to make their case before the European Medicines Agency this week as part of re-examination procedures for their respective drugs Kisunla and Aplidin.
The European Medicines Agency’s, human medicines committee, the CHMP, is this week poised to issue opinions on potential marketing approvals for 17 products.
