Tigermed Insights

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.

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.

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.

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.

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.

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.

Despite being accessible for less than a year, China’s Breakthrough Therapy designation has been much more effective than previous classifications attracting foreign enterprises.

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.

Our perspectives and insights on why you should include China into your global drug development strategy.

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.

Recently, The General Office of the State Council issued a document titled “Implementation Opinions on Comprehensively Strengthening the Capacity Building of Drug Administration”.

Drugs with a breakthrough therapy designation (BTD) enjoy significant advantages, making them a hot topic among R&D-based drug companies in China.