PERTH, Australia – Australia’s Therapeutic Goods Administration (TGA) is seeking input from industry stakeholders on a proposal to increase its fees to cover projected deficits this year. The proposal outlines three options.
BEIJING – China has finally written all its drug-related reforms into law, as it passed the amendment of its drug administration law in late August, the amendment to take effect on Dec. 1. Those moves carry one goal: to bring more and better drugs into the Chinese market as quickly as possible.
SAO PAULO, Brazil – Pharmacovigilance is emerging as a key concern for the development and distribution of biosimilars in Latin America. Experts gathered this week for the BIO Latin America conference focused on the issue and highlighted what they see as a key concern, one that is holding back the spread of that new class of drugs throughout the region.
SEOUL – South Korea's investors have become very interested in the global cell and gene therapy market. Licensing and M&A deals in the field have been active – a good sign for Korean biopharma firms eager to tap in.
PERTH, Australia – The majority of comments were positive for the Therapeutics Goods Administration's proposal for regulating in vitro companion diagnostics (IVD CDx) to ensure the devices receive appropriate premarket scrutiny.
In an era when data are more valuable than gold, China has rolled out new regulations to strengthen control of its human genetics data. Any foreign biotech companies or institutes intending to use Chinese data must engage a Chinese partner in the research project, amongst other new requirements.