New Shortage Notification Rules Bear Fruit In Australia
Moves Afoot To Better Anticipate Supply Problems
The introduction of mandatory reporting of medicine shortages in Australia has caused a sharp increase in the number of notifications. Most of them related to manufacturing problems, although commercial issues and changes in demand patterns also played a part.
You may also be interested in...
Drug sponsors will face penalties in Australia if they fail to comply with new rules on the mandatory reporting of medicines shortages that come into effect at the beginning of 2019 to replace the current "ineffective" voluntary system.
A new licensing route is to be introduced by the UK MHRA next year for products that meet specific criteria, such as treating life threatening conditions or rare diseases and where there is a significant patient need. At a webinar this week, an MHRA medical assessor looked at the requirements that products will have to meet to enter the new pathway.
Russia seeks WHO endorsement of its Sputnik V vaccine, a UK BioIndustry Association taskforce identifies potential new antibody cocktails, and the European Centre for Disease Prevention and Control considers the best strategies for targeted vaccination programs.