China NMPA and U.S FDA have been preparing regulatory establishments for the novel Coronavirus (Covid-19) since late January. Two regulatory authorities share the same progress: Emergency approval channels have been established; staff and expert panels have been mobilized to work around the clock; a variety of guidelines/ guidance and list of approved devices and virus diagnostics have been issued. China Med Device, LLC cooperates with Musculoskeletal Clinical Regulatory Advisers (MCRA) and Crmedicon to offer you an overview on regulatory response to the pandemic.
We are all experiencing this global turmoil and impact of COVID-19 on our lives. While health and safety remain our top priority, we also know how important it is to keep your current regulatory and clinical activities on track so that we can continue to drive innovation forward for our client and partners. For more information please keep updated on our monthly NMPA news roundup: https://chinameddevice.com/cmd-blogs/
Differences between FDA’s and NMPA’s response
NMPA published “Notice of Importing Non-NMPA Approved Medical DevicesV” on Jan 27, informing provincial counterparts to allow import none-NMPA approved devices but have FDA approval, CE mark, or Japan approval, to help contain the Coronavirus.
The Notice states the Emergency Approval prerequisites for overseas manufacturers:
- FDA approval, CE mark, or Japan approval
- Testing report
- Solid Quality Management System (QMS)
Meanwhile, the domestic production of protective gears is also ramped up. As of March 26, a total of 232 medical protective clothing manufacturers have been granted approval, with a maximum production capacity of 1,359,600 pieces / day; 121 medical mask manufacturers obtained approval, with a maximum production capacity of 2.938 million pieces/ day.
Diagnostic side, 15 nucleic acid assays and 8 antibody acid assays have been approved, triggered by two guidelines:
- Technical Review Key Points for Registration of COVID-19 Nucleic Acid Detection Kit
- Technical Review Key Points for Registration of COVID-19 Antigen/Antibody Detection Kit
NMPA also pays attentions on AI application on CT-imaging., which makes faster patient triage possible. On March 5, the Review Points of CT Image-Assisted Triage and Evaluation Software for Coronavirus (COVID-19)-Infected Pneumonia was issued.
“Broader types of products are needed, not only during the COVID-19 crisis, but also for post-crisis stocking,” mentions Grace Palma, CEO of China Med Device. Artificial-intelligence-related devices are one example. “Do not be limited by PPE types of products or those mentioned in media,” she advises.
FDA has a process in place for Emergency Use Authorization (EUA) to allow for expedited review and approval along with communicating to industry the requirements for specific EUAs. Each EUA is specific to a device type and dependent on the need during the emergency situation. During the COVID-19 pandemic, FDA has issued EUAs on:
- Personal Protective Equipment (PPE)
- Respirators and Face Masks
- Decontamination System
- Diagnostic Test Kits
Additionally, FDA has issued immediate release guidance on such topics as:
- Personal Protective Equipment (PPE)
- Hand Sanitizer
- Clinical Studies
- Remote Monitoring Systems
To facilitate diagnostic manufacturer’s validation, FDA also issued the templates for sample derived from respiratory specimen and serological specimen respectively.
“FDA’s EUAs and Guidance documents identify specific devise that have been determined to be of critical need. Companies should review the EUAs and guidance documents to see if you fit within the parameters FDA is communicating. If they do, they need to evaluate what validation and data they have available and how it relates to the information FDA is asking in guidance’s and/or EUAs. If they have gaps, they need to be identified early and see what can be provided in lieu of that information”, Dave McGurl, director of regulatory affairs with MCRA says.
What do regulatory professionals need to know about the process for emergency approvals in China & US?
The landscape is changing by the day as the pandemic and needs in the China and US change. It is important to keep up with the daily guidelines / guidance and emergency approval/ EUA information being provided by both authorities. Continue to expect information to come out from NMPA / FDA and other government agencies.
NMPA’s emergency approval process can be simplified that:
- Submit Application for Emergency Approval to see if you are qualified; Application materials include your home-country-approval, standards you are complied with and QMS certificate.
- If you are qualified, NMPA will assign the staff to help you go through the approval process.
FDA is using both EUAs and immediate for release guidance as a mechanism to communicate information. FDA is also hosting regular Town Halls to provide new information and allow for Q&A. Regulatory professionals need to keep on top of these communications. Information from a week ago may be obsolete.
McGurl and Palma will be among the presenters for RAPS’ 90-minute webcast, Tuesday, 7 April, covering the important guidelines, emergency approval procedures and other information regulatory professionals need regarding products that may be eligible for expedited review during the COVID-19 crisis.