New guidance from the MHRA covers the issuing of UK-wide approvals for all medicines from 2025, the conversion of Great Britain product licences to UK licences, and issues relating to the approval of generics and the use of reference and comparator products.
The UK Medicines and Healthcare products Regulatory Agency has issued new guidance for anyone who may, quite reasonably, be uncertain about what happens in 2025 when yet more post-Brexit rules on the issuing of marketing authorizations come into effect.
Among the issues addressed in the guidance are the UK’s ability to approve EU centrally authorized products (CAPs) in addition...
PTC Therapeutics is continuing to supply its Duchenne muscular dystrophy treatment, Translarna, in some European markets, despite EU revocation of the drug’s conditional marketing authorization earlier this year.
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.
Other authorities are expected to mirror the European Medicines Agency’s decision to lift the temporary restriction it placed on using Valneva’s chikungunya vaccine in people aged 65 years and older.
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.
PTC Therapeutics is continuing to supply its Duchenne muscular dystrophy treatment, Translarna, in some European markets, despite EU revocation of the drug’s conditional marketing authorization earlier this year.
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.
Other authorities are expected to mirror the European Medicines Agency’s decision to lift the temporary restriction it placed on using Valneva’s chikungunya vaccine in people aged 65 years and older.
