Six weeks before the UK is set to roll out its new International Recognition Procedure, it has developed an online tool to help facilitate a smooth and efficient process for companies wanting to use the new medicines assessment pathway.
The UK’s Medicines and Healthcare products Regulatory Agency has launched a new “eligibility checker” to support drug sponsors wanting to submit marketing applications via the upcoming International Recognition procedure (IRP).
The eligibility checker is an online tool that sponsors can use to determine whether their marketing authorization applications (MAAs)...
Biogen has U-turned on its original decision not to file Qalsody for marketing approval in the UK for treating certain patients with amyotrophic lateral sclerosis. The move appears to have been triggered by a change in the reimbursement pathway agreed for the product.
Sam Roberts, chief executive of the health technology assessment institute, NICE, will step down from her role at the end of the year. The agency is now on the lookout for a new leader, who will be the fourth in its history.
PharmaMar has voluntarily withdrawn its marketing authorization application for Aplidin to treat multiple myeloma in the EU – almost a decade after it first filed the drug for EU approval and following years of court proceedings.
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 Danish Medicines Agency is requesting that data from bioequivalence studies to be submitted in the CDISC format in addition to the current eCTD format. It believes the move will make it easier for the agency claims to access and analyze data and will reduce the burden for applicants.
Sam Roberts, chief executive of the health technology assessment institute, NICE, will step down from her role at the end of the year. The agency is now on the lookout for a new leader, who will be the fourth in its history.
Meanwhile, companies continue discussions with the Trump Administration over ways of increasing what European nations pay for drugs as an alternative to imposing a Most Favored Nation drug pricing policy in the US.
