China NMPA and U.S FDA have been preparing regulatory establishments for the novel Coronavirus (COVID-19) since late January. China Med Device, LLC, with its partner Musculoskeletal Clinical Regulatory Advisers (MCRA), will jointly hold a RAPS Webcast on China NMPA & US FDA Emergency Approval towards COVID-19.
Please opt in the webinar HERE.
For more information please keep updated on our monthly NMPA news roundup: https://ChinaMedDevice.com/cmd-blogs/
Grace Palma CEO of China Med Device, and Dave McGurl, director of regulatory affairs with MCRA, were cited by RAPS article on April 24, explaining the differences of approaches between the two regulatory authorities.
Posted 24 April 2020 | By Zachary Brousseau
In just a short time, the COVID-19 pandemic has dramatically changed the way we live and work, strained healthcare systems, and caused companies and governments to prioritize fighting the coronavirus above virtually all else. Regulators like the US Food and Drug Administration (FDA) and China’s National Medical Products Administration (NMPA) have moved to fast-track the review of products that might be used to prevent or treat COVID-19.
Regulators Speed Up Review Times
NMPA has issued more than 70 emergency approvals, including several diagnostic tests that were approved within five days. FDA has issued multiple Emergency Use Authorizations (EUAs) for critically important products, including ventilators, respirators and personal protective equipment (PPE) for healthcare providers.
FDA recently rolled out a new special emergency program to help accelerate the development of potential treatments. Multiple vaccine candidates and other therapeutics are at various stages of development (see Regulatory Focus’ COVID-19 Vaccine Tracker and COVID-19 Therapeutics Tracker for complete, regularly updated lists). One such drug, remdesivir, an antiviral originally developed to treat Ebola and Marburg virus infections, gained FDA clearance to enter a clinical trial within three days. Similarly, in China, remdesivir was approved for trial in two days, a process that normally would take months.
Regulatory Environment, FDA Crisis Response in Flux
The regulatory environment is changing rapidly, says Dave McGurl, director of regulatory affairs with MCRA, a clinical research organization (CRO). “It is important to keep up with the daily guidance and EUA information being provided by FDA,” said McGurl. “Continue to expect information to come out from FDA and other government agencies. 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.”
FDA has identified specific products that are critical needs right now. “Companies should review the EUAs and guidance documents to see if their products fit within FDA’s parameters,” said McGurl. “If they do, they need to evaluate what validation and data they have available and how it relates to the information FDA is asking for, and if they have gaps, they need to be identified early and see what can be provided in lieu of that information.”
China’s Response, Processes and Needs Differ From the US
China has had some success fighting the pandemic and is about two months ahead of the US, says Grace Fu Palma, MBA, CEO of China Med Device LLC, a regulatory and CRO consulting company. “The infection rate [in China] has been on a downward trend,” she said.
NMPA and testing centers have developed crisis guidelines and procedures that regulatory professionals need to know about, but they also must keep in mind that there are some important differences in how NMPA is handling emergency approvals, compared with FDA’s processes. In addition, Palma points out that the language and culture barriers can be significant obstacles for companies not familiar with NMPA’s processes, just as they can in non-crisis situations.
In China, guidance from NMPA is “not as detailed or specific” as the information coming from FDA, according to Palma. NMPA’s governing structure and focus are different from those of FDA, and in China, “broader types of products are needed, not only during the COVID-19 crisis, but also for post-crisis stocking,” said Palma. Artificial-intelligence-related devices are one example. “Do not be limited by PPE types of products or those mentioned in media,” she advises.
McGurl and Palma will be among the presenters for RAPS’ 90-minute webcast, Wednesday, 29 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.