Recent Revisions in Chinese Regulations Open New Doors for Contract Research Organizations: Accutest

A recent circular issued by the Chinese State Drug Administration (SDA), has opened up a large market for Contract Research Organizations (CROs) across the world. The circular (referred to as No. 52 of 2018) allows Chinese pharmaceutical companies to use clinical trial data from studies conducted outside China for their drug submissions to the SDA.

Global CROs have long been keen to enter the growing Chinese market for pharmaceutical drug testing. Sharing his views on the development, Dr. Satish Sawant, the Founder and CEO of Accutest Research Laboratories said, ‘In the current market context, it is critical for pharma companies in China to accelerate their speed-to-market. This is a challenging problem given the high cost of clinical studies in China and the shortage of high-quality CROs. Accutest has successfully partnered with leading pharma companies in China to achieve these goals. With this announcement, we will finally be able to collaborate with Chinese pharma players for their pivotal study submissions to the SDA.’

Highlighting the features of recent guidelines, Dr. Sawant elaborated stating, ‘Clinical study needs to be compliant with ICH GCP requirements and the design must be in line with the requirements of the Drug Evaluation Centre of SDA. Among other requirements, the circular specifies that submissions should include biopharmaceutical, clinical pharmacology, efficacy and safety data and confirm the validity of the study drug as a whole.’

This announcement is especially beneficial for CROs like Accutest which have an early mover advantage in the Chinese market. Dr. Sawant outlined Accutest”s work experience in China, ‘Over the past 5-6 years, Accutest has conducted more than 250 Bioequivalence (BE) clinical trials for Chinese clients, including 150+ pre-BE studies for the SDA. Accutest has also supported Chinese clients by conducting BE studies for global submissions for regulators like the US Food & Drug Administration, the World Health Organization and the European Medicines Agency. With more than 30 active clients in China, we are definitely a preferred choice as a strong and reliable CRO for SDA submission studies.’

About Accutest Research Laboratories Pvt Ltd:  

Accutest is a leading Contract Research Organization headquartered in Mumbai (India). The company works with leading pharmaceutical players to conduct clinical studies for drug testing. The company”s facilities and operations are spread across three sites in IndiaMumbai, Ahmedabad and Vadodara – housing over 425 beds. Accutest has over 700 well qualified and trained employees out of which more than half are PhDs or have Master”s degrees. The company”s service offerings include Bioavailability/Bioequivalence services (BA/BE), Clinical Development Services (CDS), Biologics and Biosimilars services. Accutest has successfully conducted more than 3,000 BE studies and has been successfully inspected by global regulatory agencies on more than 100 occasions through its history, including 30+ inspections by the US-FDA and inspections by other regulatory agencies like WHO, ANVISA, EMA, DCGI, MCC, NPRA-Malaysia, MOH-Turkey, MOH-UAE, ISP-Chile and many more.

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Vivek Singh
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Tejali Rane

NAVI MUMBAI, India, September 12, 2018 /PRNewswire/ —