The Zhejiang Institute for Food and Drug Control (ZJIFDC) is responsible for the regulatory review of food, drugs, and cosmetics produced in Zhejiang province in China.
The institute, based near Shanghai, opened the laboratory following collaboration with the Institute for In Vitro Sciences (IIVS), a non-profit organization dedicated to promoting non-animal test methods.
According to the release from the IIVS, the ZJIFDC decided to open the laboratory in 2013 to “keep in line with China's increased interest in alternatives to animal testing.”
The ZJIFDC alternatives laboratory is currently open and will provide services to domestic and international companies including several non-animal tests for skin corrosion, skin irritation, sensitization and eye irritation, though these tests are not currently accepted by the China Food and Drug Administration (CFDA).
“In addition to providing high-quality testing services, ZJIFDC serves as a model to CFDA that implementation of non-animal methods into government laboratories is achievable,” Erin Hill, IIVS president told Outsourcing-Pharma.com.
Services also include the first CFDA-approved non-animal method to determine a cosmetics product's potential to cause harm after exposure to light.
“Cosmetics are lower hanging fruit for making changes since most of the products are non- or minimally-irritating,” said Hill.
Hill explained that as in other parts of the world, adoption of non-animal testing methods in the cosmetics sector will pave the way for adoption in other areas, such as drug development.
“There are a staggering number of drugs that fail in development due to toxicology problems,” she added. “So the earlier a pharma company can implement human-relevant endpoints the better.”
Prior to opening the ZJIFDC alternatives laboratory, the institute partnered with IIVS to receive technical training in the implementation, execution, data interpretation, and quality practices associated with a non-animal testing laboratory.
“IIVS provided training at the laboratory in Zhejiang and also hosted their scientists for extensive training at our headquarters in Gaithersburg, MD,” said Hill.
IIVS also provided protocols, standard operating procedures, and workbooks.
The non-profit also recently partnered with researchers to develop a replacement for the Rabbit Vaginal Irritation Test (RVI), which is the most commonly used method to assess the potential of personal lubricant to cause irritation.
The project received the FDA go-ahead as the agency looks to modernize tests used to develop and evaluate medical devices.