“Welcome to Fisher Clinical Services, Beijing. There are several reasons why China is of interest to global pharma companies– large patient pools of treatment naive patients; a wide spectrum of western pattern infection and chronic diseases; high patient recruitment, enrollment & retention rate; a talent pool of highly trained healthcare professionals; improved infrastructure; potential for cost savings.
Challenges also present themselves – regulatory hurdles; protracted timelines for clinical trial approval; ongoing healthcare reforms; different import/export requirements; cultural differences in the application of GCP and GMP as well as cultural and language barriers that need to be surmounted.
From importation to storage, to comparator sourcing, complex packaging projects and distribution of clinical supplies through to returns and destruction, the Fisher Clinical Services Beijing multi-lingual team of experts makes the clinical trial chain simpler and safer. Find out more about the services we provide to facilitate the smooth execution of clinical trials in China.”
Ianne Loh General Manager, Fisher Clinical Services, Beijing
Fast Facts on the Healthcare Industry in China:
- The fastest growing region for the number of registered clinical trials is Asia-(clinicaltrials.gov).
- China is the world’s fastest growing pharmaceutical market, projected to be ranked second by 2020 with revenues experiencing continued double-digit growth.
- Almost 1/3 of China’s population will be over 60 by 2050- (United Nations).
- In June 2017 the ChiCTR – Chinese Clinical Trial Registry – was accepted as the 4th WHO ICTRP Primary Register- to unite healthcare professionals to manage clinical trials in China.
- China’s Food and Drug Administration CFDA requires clinical trial sponsors to register all trials (Phase I, II, III, IV) & bioequivalence testing within one month after pre-registration of the trial.
- Understanding ICH GCP & CFDA GCP requirements is key to success for clinical trials in China.
- Anticipate a lengthy approval process. It takes approximately 10 months for the CFDA to approve clinical trial applications
- Many pharmaceutical and biotech companies are attracted to China as an established base for clinical trials.