Select Page

Tigermed Insights

Home » 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.

Annual Report on Clinical Trials for New Drug Registration in China (2020)

Annual Report on Clinical Trials for New Drug Registration in China (2020)

In order to better understand the current status of clinical trials for new drug registrations in China; to disclose clinical trial progress information to the public; to provide reference for new drug research and development (R&D), resource allocation, drug review and approval for the industry; and to explore the use of informatization technology to improve the ability of intelligent supervision of drugs, the Center for Drug Evaluation (CDE) has conducted the first comprehensive summary and analysis of clinical drug trials in China according to data from the Drug Clinical Trial Registration and Information Disclosure Platform.

Clinical Trials Ultimately Aim to Improve Human Health

Clinical Trials Ultimately Aim to Improve Human Health

It is our common understanding that the success of a global clinical study depends often on selecting the right country, with considerations of medical infrastructure, research experience and accessible patient population. Korea, recently became a role model for boosting clinical industry, has been recognized as hub of healthcare innovation and the leading clinical trial destination in the Asian region.

Clinical value is top priority in cancer drug trials, CDE says.

Clinical value is top priority in cancer drug trials, CDE says.

While Chinese regulators have been receiving more IND filings for oncology drugs, treatment targets and indications have been jammed into a few choices, such as PD-1/L1 and VEGFR. Regulators are now trying to turn things around with a top-down approach.

ICH Guidelines in China: Where are we now?

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.