On April 1st, the CFDA issued an announcement on the application for self-examination and verification of drug clinical trial data (No. 81 of 2016) and related to the implementation of the “Opinions of the General Office of the State Council on the Evaluation of the Quality and Efficacy of Generic Drugsâ€. Matters (draft for comments). On the afternoon of April 12, the General Administration of the People's Republic of China issued the "Provisional and Recommended Procedures for the Comparison of the Quality and Efficacy Evaluation of Generic Drugs" (Draft for Comment), and the time for comments was as of April 30. Generic consistency assessment entered acceleration. At the same time, the clinical data verification storm continues. On April 1st, the General Administration of the People's Republic of China announced the list of 181 drug clinical trial data self-checking and registration applications. According to the process, the on-site verification date will also be announced. On April 12th, the General Administration reissued the "Notice on Soliciting Opinions on the Field Inspection Procedures and Checkpoints of Medical Devices Clinical Trials", and announced the inspection procedures and key points, which means that the clinical inspections have hit the medical equipment! In fact, the sharp increase in the speed of clinical data verification + consistency evaluation is the performance of the country in the strong push for medical supply testing reform. For pharmaceutical companies, who can laugh at the end in this round of reforms? Recently, the analysis report issued by Southwest Securities pointed out that the new drug administration is beneficial to three enterprises. First, leading enterprises and R&D-driven enterprises. Second, the export export enterprises that have passed the overseas standardized market verification and can be exempted from the consistency evaluation in China. Third, the CRO enterprises that have increased the clinical trial price and price brought by the direct benefit consistency evaluation. Why is this conclusion? The analysis report believes that: First of all, it is imperative to improve the quality of medicines and the concentration of the industry. The reform of the supply side of the pharmaceutical industry is pushing forward. Due to historical reasons such as policy and supervision, a large number of pharmaceutical production approvals flocked to the market before 2007, and the quality of generic drugs was generally not guaranteed. As a result, the current import of original drugs was super-national treatment, while the domestic generic drugs competed in the Red Sea. currency. At present, there are nearly 5,000 pharmaceutical preparation enterprises in China, and the number of approved drugs is about 170,000. The concentration of the industry is far below the international level. It is imperative to improve the quality of medicines and promote the concentration of the industry. Under the background of promoting the innovation and upgrading of the pharmaceutical industry through supply-side reform, the state has issued new policies such as GMP certification, clinical data verification, chemical registration classification reform, priority review and approval, and generic drug conformity evaluation in the past year. Strongly promote the supply side reform of the pharmaceutical industry. At present, 3,000 companies have passed the new GMP certification, and nearly 2,000 companies are facing production suspension. In addition, the clinical data verification and generic drug conformity evaluation will rectify the drug approval core drug approval. As a whole, the current domestic industry drugs are entering the era of good money and bad money, and the industry concentration will be greatly improved. Secondly, clinical data verification controls the increment of approvals and improves the quality of R&D and declaration. In recent years, CDE has accepted 8,000 applications for registration every year. In order to solve the problem of drug declaration extrusion and clinical trial irregularities and fraud, the clinical data verification was initiated in July last year, involving 1,622 varieties, with a total failure rate of 75%. After the verification, the monthly average declaration volume decreased by nearly 60%. The verification was 181 varieties produced by the new report. The two inspections covered all the drugs being reported for production. On March 29, the CFDA issued a verification procedure for the clinical trial data of the drugs (provisional), indicating the verification of clinical trial data. Entering the normal state, the normalization of clinical data verification will help improve the quality of drug development and declaration, and benefit R&D-driven enterprises. Finally, generic drug consistency assessment addresses stocks and promotes industry concentration. At the beginning of March, the General Office of the State Council issued the "Opinions on the Evaluation of the Quality and Efficacy of Generic Drugs", which marked the rise of the consistency assessment to the national will. According to the latest consultation draft, it is clear that the base drug oral solid chemical generic drug approved before October 2007 must be completed before the end of 2018, and other generic drugs approved for marketing before the new chemical registration classification is implemented. After the varieties have passed the consistency evaluation, the other identical varieties should in principle complete the consistency evaluation within 3 years. This means that the conformity assessment covers all listed chemical generics and sets a deadline, which means that the policy involves each pharmaceutical company in its stock. It is expected that a large number of small pharmaceutical companies without R&D strength may die without approval. In the future, there will be three unique market patterns for each generic drug, and the concentration of the generic drug industry will increase rapidly in the next three years. From the trend point of view, the national drug regulatory policy is moving toward Europe and the United States, clinical data verification and generic drug conformity evaluation and other policies have formed a medium- and long-term positive for the pharmaceutical industry. Kn95 5 Layers Mask,Kn95 Filters Face Mask,Kn95 5 Layers Cup Facemask,Kn95 5 Layers Fold Flat Facemask Jiangmen anjian biotechnology co. LTD , https://www.jmanjianmask.com