Recently, the State Food and Drug Administration issued a working procedure for the evaluation of the quality and efficacy of generic drugs, and publicly solicited opinions from all sectors of society. On March 25th, Shandong Xinhua Pharmaceutical Co., Ltd. cooperated with Jingdong Shanyuan to launch the first “pre-pharmaceutical drug transfer†project in the country.
CFDA Opens Work Procedures for Conformance Evaluation of Quality and Efficacy of Generic Drugs
On March 28, the State Food and Drug Administration issued the “Working Procedures for the Evaluation of the Quality and Efficacy of Generic Drugs (Draft for Comment)†and the “Requirements for the Evaluation of the Conformity Evaluation of Oral Solid Chemicals for Chemical Drugs (Consultation Draft)†All provincial food and drug supervision and management departments and all sectors of the society publicly solicit opinions. The main contents are as follows:
1. The pharmaceutical production enterprise is the subject of the consistency evaluation. For generic drugs (including imported generic drugs), reference should be made to the "Guidelines for Selection and Determination of Reference Preparations for Oral Oral Solid Preparations", the reference preparations should be selected, and the reference preparations should be used as comparative drugs for comprehensive and in-depth comparison studies.
2. Imported generic drugs that have been listed in China are submitted to the Food and Drug Administration General Administration Acceptance Service and Complaint Reporting Center for submission and declaration of conformity evaluation information as required.
3. The Office of Conformity Evaluation may notify the Verification Center to conduct a cause check based on the problems found during the technical review process of the conformity assessment.
4. The Food and Drug Administration will announce the results of the conformity assessment to the public in a timely manner; if the application is supplemented, the “Approval for Drug Supplementation†will be issued and deemed to have passed the consistency evaluation.
5. The Office of Conformity Evaluation is responsible for providing consultation and guidance on the relevant policies for conformity evaluation; the Drug Evaluation Center of the Food and Drug Administration is responsible for consulting and guiding the bioequivalence test and clinical effectiveness test; the verification center is responsible for inspection and development of the production site. On-site verification and clinical research verification for consultation and guidance.
Online sales of prescription drugs opened in the country, the first "prescription drug e-commerce" project started
On March 25, Shandong Xinhua Pharmaceutical Co., Ltd. and Jingdong Shanyuan (Qingdao) E-Commerce Co., Ltd. signed a “Healthy City†strategic cooperation agreement. The signing of this agreement marks the first government-led public hospital in the city. The target “prescription off-site transfer†project and the first “prescription drug e-commerce†project approved by the government were officially launched.
It is understood that Xinhua Pharmaceutical cooperates with Jingdong to establish a set of hospital information systems (HIS), doctors, medical prescription circulation information platform, cloud pharmacy platform, social pharmacy, distribution system, etc. among public hospitals in Zibo City. Complete new informational prescription circulation and pharmaceutical circulation platform system. The system will connect the public pilot hospitals in Zibo City and electronically transfer the prescriptions to designated retail pharmacies outside the hospital. The citizens can then purchase the information from the electronic pharmacies and the e-commerce platform. To related medical products including prescription drugs.
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