Five Products Enter the Pathway for innovation and Priority Review
On August 30, 2021, 5 products were approved by NMPA (former CFDA) to enter the innovation pathway and priority review pathway. Details are as follows:
| No. | Product name | Applicant | Pathway |
| 1 | Paclitaxel-Coated Peripheral Balloon Catheter | TriReme Medical, LLC | Innovation |
| 2 | Transcatheter Mitral Clamp and Steerable Guide Catheter | Shanghai Shenqi Medical Technology Co., Ltd. | Innovation |
| 3 | Extramacular Compression Band | Guangzhou Ruiqina Medical Technology Co., Ltd. | Innovation |
| 4 | Atherectomy System | Boston Scientific Corporation | Innovation |
| 5 | Coronary Intravascular Shock Wave Catheter | Shockwave Medical, Inc. | Priority Review |
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Entering the innovation pathway does not mean that the product are safe and effective enough to be approved. The applicant still needs to modify the product and submit the registration dossiers according to the NMPA (former CFDA) requirements. The registration standards and procedures will not be lowered and simplified. However, the benefits for the manufacturer will be:
- Early participation of the NMPA (former CFDA) before submitting the registration dossiers.
- A designated NMPA (former CFDA) reviewer during the whole registration phase.
- Much closer communication with the NMPA (former CFDA) reviewer.
Similarly, for the projects subject to priority review, the registration standards and procedures remain unchanged. Nevertheless, NMPA shall accelerate the efficiency of review and approval in all aspects. Priority will be given to technical review, inspection on quality management system and administrative review, shortening the time for product marketing and ensuring that the corresponding products can be applied in clinical use as soon as possible. For example, the coronary intravascular shock wave catheter is urgently needed in clinical use and there is no predicate approved for registration in China, it is approved to enter the priority review pathway.
As a professional consulting company, we have helped many of our clients in the application of the innovation and priority pathway. If you are not sure whether this is the right way for your product, please contact us (info@inspirativemed.com) and our seasoned staff can help you with the assessment.
