A new guidance document explains how Pakistan’s revamped pharmacovigilance system will work.
The Drug Regulatory Authority of Pakistan has issued a guidance document designed to implement a more robust pharmacovigilance program for monitoring the safety of medicines and other therapeutic goods in the pre- and post-marketing settings.
In line with Pakistan’s National Health Vision 2016-2025, the program aims to establish “vibrant pharmacovigilance centres at national level and...
Chiesi’s orphan drug Raxone has secured an English funding recommendation for the treatment of Leber's hereditary optic neuropathy, a decade after the orphan drug was approved for marketing. Chiesi told the Pink Sheet about its “long, and often challenging” road to reimbursement.
Norucholic acid and leriglitazone, for treating primary sclerosing cholangitis and cerebral adrenoleukodystrophy, respectively, are among 12 new drugs that the European Medicines Agency has started to review for potential EU marketing approval.
Although the UK Health Research Authority’s initial proposal for simplified informed consent was rejected by stakeholders, it has yielded valuable insights into reducing trial burden and widening access
