Obviously, CFDA also noted this point. Yesterday (December 6), CFDA issued a notice, asking sapais to start the clinical effectiveness test as soon as possible, and to report the evaluation results to the drug evaluation center of the State Food and drug administration within three years.
According to the tips of the Shanghai Stock Exchange, sepsis suspended trading all day today.
General Administration of food and Drug Administration: report the clinical effectiveness test within three years
On December 6, the State Food and Drug Administration issued a notice of the General Administration on matters related to saps eye drops. The full text is as follows:
Zhejiang food and Drug Administration:
In view of some doctors in the medical field questioning the efficacy of benzalalysine eye drops (trade name: sapais) produced by Zhejiang sapais Pharmaceutical Co., Ltd., please urge the enterprise to start the clinical efficacy test as soon as possible in accordance with the drug administration law of the people's Republic of China and the relevant provisions of the quality and efficacy consistency evaluation of generic drugs, and the evaluation results will be made within three years Report to the drug evaluation center of the State Food and drug administration. In order to prevent misleading consumers, the approved advertisement of the drug shall be expressed in strict accordance with the words specified in the indications of the instructions, and there shall be no words beyond the indications of the instructions.
Food and Drug Administration
6 December 2017
On the morning of December 7, the Zhejiang food and Drug Administration issued a notice in response to the statement that it had forwarded the notice of the State Food and drug administration to sapais, and asked the company to immediately carry out advertising self inspection, and immediately correct the non-compliance.
According to the report, sapais eye drops launched a brainwashing campaign against the elderly group with an overwhelming advertising campaign, and carried out misleading publicity with the advertising language of "cure all diseases", and finally achieved a remarkable sales performance of 750 million yuan a year. But in fact, it not only has no definite effect on cataract and other ophthalmic diseases, but also delays the best treatment time for numerous elderly patients, leading to more serious diseases or complications.
So, how can a highly misleading advertisement, such as' cataracts, blurred eyes, blurred eyes, dark eyes, bright eyes and happy old age ', be approved by relevant departments? Legal experts point out that enterprises adopt the strategy of' erasing the edge of the ball '. Its advertising language does not directly violate the express provisions of relevant laws and regulations, and does not belong to the list of prohibited words listed in specific legal provisions.