Injectable Consistency Evaluation Promotion | Exporting Business or Benefit

Pharmaceutical Network February 5 hearing the injection of consistency assessment will promote the industry reshuffle, the injection of export enterprises benefit .54 paper proposed, through re-evaluation, to enjoy the chemical generic drug oral solid preparation quality and efficacy consistent assessment of the relevant policies. Export enterprises have a first mover advantage. In the future, it is expected to seize the market through the policy dividend and substantially enhance their competitive advantages.

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 by the FDA Orange Book, select the reference formulation for conformance evaluation, 2) listed injections do not have complete and adequate safety, effectiveness data, it is necessary to carry out drug Re-evaluation of the work 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 formulations, change the salt-based products under pressure in the reference draft in the reference preparation, prescription technology, raw materials Accessories Packaging material quality control, quality research and control technology, stability research and other aspects of the request, and the special injection (such as liposomes, intravenous milk, microspheres, suspension injection, etc.) consistency is described. , For changing the specifications of injection, requires full demonstration of scientific, reasonable and necessary; for the modified and modified salt-based injection, requires proven evidence of 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 the policy dividend to seize the market, significantly enhance the competitive advantage. medicine , Puli Pharmaceutical, Jian You Shares, it is recommended that attention Haisheng Pharmaceutical, Hai Purui, etc .. Of which: Heng Rui medicine cyclophosphamide, docetaxel, irinotecan, dexmedetomidine, cis atracurium, Austria Saliva platinum and other six species obtained the United States ANDA approval, is currently the United States most injections ANDA injection enterprise Puli Pharmaceutical's azithromycin has passed the first review and listing in August 2017 and became the first domestic product to be reported for the successful export of preparations.Jiayou shares have been sold in the United States for two products, carboplatin and atracurium Several are studying the newspaper products, and the next two years there are heavy varieties such as enoxaparin are expected to be approved in Europe and the United States.