Shapuaisi ordered to test eye drops: CFDA
The China Food and Drug Administration (CFDA) told its office in Zhejiang Province to ensure that Shanghai-listed Zhejiang Shapuaisi Pharmaceutical Co conducts clinical tests on eye drops, according to a notice on the CFDA’s official website on Wednesday.
The CFDA told Shapuaisi to start the tests as soon as possible and submit the results within three years to the administration.
The move, coming after doctors raised concerns over the effectiveness of the company’s Shapuaisi eye drops, is intended to avoid misleading patients by verifying that ads for the product are consistent with the syndromes its instructions indicate, according to the CFDA.
The Zhejiang Food and Drug Administration (ZFDA) said it forwarded the notification to Shapuaisi Pharmaceutical Co on Thursday.
The company should also verify slogans and ads for the eye drops and make necessary corrections, reporting to the local market supervision and administration, according to a post on the ZFDA website.
Shapuaisi Pharmaceutical Co is responsible for ensuring the quality and safety of the product throughout the product’s life cycle, the post said.
The process involved in the case is long as the CFDA will need time to collect evidence and verify the research and development for the medicine, according to Dong Yizhi, a research fellow with the China eBusiness Research Center.
Dong told the Global Times that the issues reflect loopholes in the regulations covering the Chinese pharmaceutical industry.
“If the advertising laws and verification for drug-related advertisement were reinforced, some misleading ads could have been avoided,” he said.