ADVERTISEMENT
Asia Pacific
The Therapeutic Goods Administration is advising companies to get up to speed with its new recall procedure, which is designed to improve the timeliness of recalls, alerts and corrections, and reduce regulatory burden for sponsors.
The Therapeutic Goods Administration is advising companies to get up to speed with its new recall procedure, which is designed to improve the timeliness of recalls, alerts and corrections, and reduce regulatory burden for sponsors.
The Therapeutic Goods Administration says it wants to balance regulatory burden on sponsors with the need to improve its monitoring of medicine shortages.
The government’s decision for the Pharmaceutical Benefits Advisory Committee to hold an extra meeting in 2025 has been welcomed by Medicines Australia, which says that Australians already wait on average 466 days from the time a medicine is approved to when it is subsidized.
The five-year roadmap aims to expand support for AI research and development in essential health care and new drug development, as well as advance medical data usage systems and enable its safe use.
Medicines Australia has expressed skepticism over the Pharmaceutical Benefits Advisory Committee’s claim that in March 2025 it will only be able to assess 32 submissions from companies that want to get their drugs subsidized under the Pharmaceutical Benefits Scheme.
Swissmedic has removed the requirement for companies to participate in accelerated application hearings in certain situations.
Axcynsis is developing a derivative of the chemotherapy agent Yondelis as a new payload, which the Singapore venture will first apply to a Claudin 6-targeting ADC it plans to take into a Phase I trial in the US, its chairman, CEO and founder tells Scrip in an interview.
The Philippines medicines regulator explains how it intends to implement the ASEAN mutual recognition agreement under which member states have committed to accept bioequivalence study reports for generics issued by approved BE centers.
Recent major developments in the Korean biotech sector include Orum Therapeutics’ IPO plan and HLB’s US resubmission for the approval of rivoceranib in combination with camrelizumab for first-line liver cancer.