Injection Consistency Evaluation will promote the industry reshuffle, injection export enterprises benefit .54 paper proposed, through re-evaluation, enjoy the quality of chemical generic oral solid preparations and the efficacy of the consistency assessment of the relevant policies. Injection export enterprises have the first-mover advantage, The future is expected by virtue of policy dividends to seize the market, significantly enhance the competitive advantage.
Policy over time than expected, indicating that this drug administration departments to promote drug supply side reform determination.In recent months, drug regulatory department policies are frequent, the introduction of the progress of the implementation of the fast and resolutely exceeded expectations, to speed up innovation drugs Evaluation and conformance evaluation are all demonstrating the determination of the state to promote the drug supply side reform and to improve the quality of domestic medicines in line with the international standards.At present, there are many small and medium enterprises in the country, and after this round of supply-side reform, it is expected to substantially increase concentration Degree, the leading enterprises in the market share is expected to be significantly improved.
The distinction between 'consensus evaluation' and 'reevaluation' started with the injections 'conformance evaluation, which was first mentioned in the CFDA's Circular 54 in May 2017. It states:' According to the Drug Administration Law Regulations, according to the scientific progress of the pharmaceutical injection, re-evaluation of the safety, effectiveness and quality control of the approved injection has been carried out, and strive to basically complete the re-evaluation of the listed injection in about 5 to 10 years. , To enjoy the chemical generic drug oral solid preparation quality and efficacy of the consistency of evaluation of the relevant policies. 'The release draft for solicitation, clear carry out injections consistency assessment: 1) has been listed in the injection is a complete and adequate safety and effectiveness Data, or are accepted by the FDA Orange Book, select the reference formulation for consistency assessment, 2) the listed injection does not have complete and sufficient safety, validity data, the need for drug re-evaluation. Times on the technical requirements of the draft is the refinement of technical issues, which means that injection consistency assessment began to advance.
The technical requirements and the United States FDA's technical guidelines are very similar, change the specifications, change the type, to change the salt-based products under pressure.The draft on the reference preparation, prescription technology, raw materials, packaging materials quality control, quality research and control Technology, stability studies and other aspects of the request made, and the special injection (such as liposomes, intravenous milk, microspheres, suspension injection, etc.) consistent evaluation.In addition, the change specifications for injection, requires full demonstration Scientific, reasonable and necessary; for the modified formulations and salt-based injection, the need to prove that there are obvious clinical advantages. Change the specifications, change the type, change the salt-based products in the future will face the pressure.
Injection Consistency Evaluation will promote the industry reshuffle, injection export enterprises benefit .54 paper proposed through re-evaluation, enjoy the quality of chemical generic oral solid preparations and the efficacy of consistent assessment of the relevant policies.Important injection enterprises with first-mover advantage, The future is expected by virtue of policy dividends to seize the market, a substantial increase in competitive advantage.Highlights: Hengrui Pharmaceutical, Puli Pharmaceutical, Jianyou shares, it is recommended to pay attention to Hisun Pharmaceutical, Hai Purui, etc .. Of which: Hengrui medicine cyclophosphamide, His race, irinotecan, dexmedetomidine, cisatracurium, oxaliplatin and other six species obtained the US ANDA approval, is the current domestic injection of the United States ANDA approved the largest enterprises. Puli Pharmaceutical azithromycin already in In August 2017, it passed the first review and listing and became the first product to be reported as successful export in China.Company has already sold two products of carboplatin and atracurium in the United States, In the next two years, there will be heavy-grade varieties such as enoxaparin approved in Europe and the United States.
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