China’s Evolving Innovation Landscape: New DIA Global Forum Article
A new article authored by CIRS' Dr Tina Wang and Dr Neil McAuslane, together with Prof Jin Wang of the OmniChain Med Institute, has been published in the September [...]
CIRS RD Briefing 104 – Class 1 Innovative Medicines Approved in China: An International Comparison
As pharmaceutical innovation becomes increasingly global, companies are pursuing multi-jurisdictional approvals and timely patient access through evolving regulatory and reimbursement pathways. In China, regulatory reforms and expanded use of [...]
CIRS RD Briefing 102 – Tracking Availability in China of Medicines Approved in Six Key Global Markets
All approved medicines have been rigorously assessed by regulatory authorities to ensure their benefits outweigh the risks. Today, pharmaceutical companies are increasingly focused on integrated global drug development strategies, [...]
CIRS RD Briefing 84 – China’s evolving regulatory landscape
China has made significant changes to its medicine regulatory system including: Regulatory reforms - since 2015, regulatory reforms have helped to eliminate application backlogs, improve review timelines and increase [...]
CIRS RD Briefing 56: Understanding the dynamics of China’s regulatory environment
Changes have occurred in the organisation and procedural activities of the China Food and Drug Administration (CFDA) and the Centre for Drug Evaluation (CDE). Initiatives that were designed to [...]