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.
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.
What’s New for Drug R&D and Evaluation Communication in China?
The drug evaluation communication meetings in China are classified into 3 types according to newly issued “Drug R&D and Evaluation Communication Regulation”.
Best Practices In Effective Central Laboratory Support
In this blog, we describe best practices in effective central laboratory and factors to take into account when selecting a central laboratory partner.
What’s new for conditional approval of drugs in China?
After the two rounds for seeking public comments in 2017 and 2019, The Technical Guidelines for Conditional Approval of Drugs was put into force by NMPA in Nov 2020.
Video: Including China into Your Global Drug Development Strategy ─ Why, When and How?
Our perspectives and insights on why you should include China into your global drug development strategy.
What’s new for the clinical technical requirements of the innovative drugs marketed overseas but not in China
Here is what you need to know about newly-issued drug registration instruction in China.
Video: What’s New for Drug Registration in China?
Learn more about new policies and challenges of drug registration in China from Jianqing Chang, VP of Drug Regulatory Policy, Tigermed.
Policy Interpretation of Measures for the Administration of Drug Registration
A deep interpretation of newly updated Measures for the Administration of Drug Registration in China.
What’s New for the MAH in China?
After the pilot program in ten provinces and municipal cities for 3 years, the MAH system becomes one of the twelve chapters of the revised Drug Administration Law, which was put into effect since De 1, 2019.
What’s New for Clinical Trials in China?
On March 30, 2020, the revised Drug Registration Regulation (DRR) was issued by the State Administration for Marketing Regulation and will be put into effect from July 1, 2020
