Ali Health released a notice that the latest revision of GSP has little effect on it
Today, Ali Health announced that the State Food and Drug Administration (hereinafter referred to as "CFDA") issued the "Decision on Amending the Quality Management Regulations for Pharmaceutical Products" (hereinafter referred to as "the Decision") issued by the State Administration of Food and Drug Administration (hereinafter referred to as "CFDA"). The terms of the cancellation of the electronic drug regulatory code are expected to have little impact on the company's overall operating income and will not have a material adverse effect on future revenue, business and operating results. On July 20th, the CFDA released a revised version of the "Good Manufacturing Practices" (hereinafter referred to as "Grucology GSP"). In fact, in February 2016, the CFDA issued an announcement to suspend the implementation of the relevant provisions on electronic drug supervision. Public consultation on the "Code for the Quality Management of Pharmaceutical Products" (Revised Draft). The final revised version of the drug GSP completely removed the expression of the drug electronic regulatory code, which also means that the original national drug electronic regulatory code officially withdrew from the historical stage. details as follows: (1) Delete the original Article 81, the original Article 82, the original Article 102, and the original Article 176 (all of which are related to the electronic supervision code). (2) Delete the original “Article 8†and “Scan and Data Upload of Drug Electronic Supervision Codeâ€, and the original Article 161 “Drug that implements electronic supervision shall also be in accordance with Article 80 of this Code. One, the provisions of Article 82 shall be scanned and data uploaded." (3) The enterprise quality management system shall include the “Regulations on the Implementation of Electronic Control of Drugs†in the project as “Regulations on Drug Traceabilityâ€. Specifically, it refers to the original Article 36 (21) and the original Article 138 (17). (4) Delete the contents of the original Article 57 “and meet the implementation conditions for electronic supervision of drugsâ€. (5) Amend the original Article 149 to “Enterprises should establish computer systems that meet the requirements of operation and quality management, and meet the requirements for drug traceabilityâ€. Acne Pimple Patch,Diy Pimple Patch,Pimple Band Aid,Peace Out Acne Dots Wenzhou Celecare Medical Instruments Co.,Ltd , https://www.wzcelecare.com