Tigermed Insights
At Tigermed, we believe knowledge needs to be shared to further develop clinical programs, increase market access, and to meet unmet patients needs. This is why we share publications, blogs and other insights here.
Hear from thought leaders and other subject matter experts on the topics, trends and market developments that are relevant to clinical trials and related areas. Remember that you are always invited to request additional information or suggest a topic you would like to learn more about. Use the contact page to reach us for any requests.
ICH Guidelines in China: Where are we now?
In 2017, the Chinese National Medical Products Administration (NMPA) was welcomed as a new regulatory member of the ICH. Only a year later, in June 2018, China’s health regulatory authority (National Medical Products Administration, NMPA) was elected to the ICH Management Committee, enabling the country to continue participating in international drug development and registration.
More Chinese biotech startups are testing their new drugs but slowly, CDE report reveals.
Chinese regulators are seeing more clinical studies of new drugs initiated by domestic startups, but they are concerned about slow clinical progress and inadequate care for young and old patients, a recent report revealed.
Risk-based Quality Management：A Transformative Approach for Clinical Trial Monitoring
As an innovative shift in clinical trial monitoring model, Risk-based Quality Management (RBQM) strategy could improve the overall performance on cost saving and efficiencies of clinical trial, and provide a simple approach to reduce or limit potential risk.
The Breakthrough Therapy Designation in China: A Magnet for Foreign Companies
Despite being accessible for less than a year, China’s Breakthrough Therapy designation has been much more effective than previous classifications attracting foreign enterprises.
A Revolutionary Approach for Evolutionary Development – A Conversation with James Brook
James Brook, a UK-based senior leader with 25+ years of experience in healthcare and clinical research, joined Tigermed in June 2021 as Regional Head of Western Europe, Africa and Pakistan to lead and build capabilities in these areas.
Video: Including China into Your Global Drug Development Strategy
Our perspectives and insights on why you should include China into your global drug development strategy.
Increasing More Opportunities for Better Treatment – A conversation with Dr. Charles Schmidt
We recently had an engaging conversation with Charles, an experienced leader who speaks four languages and wears many hats from academy to business, to discuss his vision regarding Tigermed’s Latin America strategy and how to bring innovative products to patients.
China Authority is Taking Initiatives to Enhance its Drug Administration Capabilities
Recently, The General Office of the State Council issued a document titled “Implementation Opinions on Comprehensively Strengthening the Capacity Building of Drug Administration”.
What’s New for Getting Breakthrough Therapy Designation for Drugs in China？
Drugs with a breakthrough therapy designation (BTD) enjoy significant advantages, making them a hot topic among R&D-based drug companies in China.
What‘s New for the Administration of the Drug Post-approval Changes in China
Following the latest revision of China’s drug administration law from December 2019, drug life cycle management has become a key obligation for Marketing Authorization Holders (MAHs).
Orphan Drug Development in China
In this blog post, we will shortly outline the regulatory framework for orphan drug development in the USA and Europe, and then focus on recent developments and future prospects in China.
The Potential of Real-World Data
Learn what needs to be taken into account when planning to collect and use Real-World Data.
