The NMPA expert panel convening scientists, medical experts, government officials, manufacturer’s representatives and Clinical Research Organizations (CROs) from transcontinental locations is delivered online for the first time. The virtual conference is to weigh the available evidence and provide scientific and medical advice on the safety and efficacy of an imported Class III device represented by China Med Device, LLC.
Physical Meeting & Teleconference
Due to the outbreak of the novel Coronavirus (COVID-19), the physical meeting became Impossible. As the registration process progresses, China Med Device initiated the meeting and facilitated it, providing the virtual system assistance and coordinating the time between experts and officials.
The virtual meeting turns out to be a better option. The physical meetings usually cost three months to prepare. Countless written materials had to be printed. Experts and staff from different parties in the globe had to be gathered. With the meetings going virtual, the scientific opinions can be delivered to manufacturers more effectively and efficiently.
Amid the COVID-19 crisis, China NMPA has taken many measures to utilize the E-channel:
- High-efficiency online office in China, covering Chinese regulatory authorities, hospitals, type testing centers and Human Genetic Resources (HGR) offices
- Suspend paper document registration and mandate E-submission
- Suspend face-to-face NMPA pre-consultations; Applicants shall call Center for Medical Device Evaluation (CMDE)
- Suspend face-to-face supplement phase evaluations; Applicants shall apply on CMDE website
- Suspend face-to-face meetings for Innovation Application, Priority Review, and Clinical Trial Application; Applicants shall contact CMDE and set up an E-meeting
- Decreased paperwork for IRB/EC approval, HGR filing, local NMPA filing, etc. Sponsors must submit electronically and use an E-signature
- Transformed EC review, utilizing E-submission and remote meetings with committee members
- More frequent use of a database for patient registry and Adverse Event monitoring
- Increased remote supervision and decreased visits by CRO staff to cut down service fees
- More Electronic Data Capture (EDC) applied to medical device clinical trials instead of paper CRF, etc.
NMPA published the “Guideline on Expert Panel/ Public Advisory Meeting” on December 5, 2019. Please click HERE for our post.