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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.
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).
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.
Learn what needs to be taken into account when planning to collect and use Real-World Data.
The drug evaluation communication meetings in China are classified into 3 types according to newly issued “Drug R&D and Evaluation Communication Regulation”.
In this blog, we describe best practices in effective central laboratory and factors to take into account when selecting a central laboratory partner.
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.
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.
Learn more about new policies and challenges of drug registration in China from Jianqing Chang, VP of Drug Regulatory Policy, Tigermed.
A deep interpretation of newly updated Measures for the Administration of Drug Registration 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.
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