Australia switches chloramphenicol eye drops
This article was originally published in The Tan Sheet
Executive Summary
Australia moves chloramphenicol-containing eye drops to nonprescription distribution by pharmacists, harmonizing the country's regulation with New Zealand's. The National Drugs and Poisons Schedule Committee in October said that other nonprescription products are indicated for mild cases of bacterial conjunctivitis, but it is "sensible to allow pharmacists to supply cholramphenicol for the treatment of more severe, uncomplicated cases." Australia and New Zealand are harmonizing requirements for therapeutic products and establishing a joint regulatory scheme under the Trans-Tasman Mutual Recognition Arrangement (1"The Tan Sheet" Feb. 2, 2009). Chloramphenicol-containing eye drops remain Rx in the U.S
You may also be interested in...
Therapeutic Product Regulatory Reforms Considered Down Under
Australia's Therapeutic Goods Association plans to implement a number of regulations to update and streamline the existing framework for over-the-counter and prescription drugs as well as medical devices
Second EU MDR Notified Body Designated In France
Four years after the designation of the first notified body in France under the Medical Device Regulation, AFNOR Certification has been named too.
Takeda, Astellas Found New JV To Support Japanese Bioventures
Major Japanese companies Takeda, Astellas and SMBC are joining hands to establish a new joint venture with $3.9m capital and based in Japan’s largest biocluster Shonan iPark to help incubate local biopharma start-ups.