Asia Regulatory Roundup: NMPA seeks to ensure quality of exports as China becomes key supplier of COVID-19 devices

RoundupsRoundups | 07 April 2020 |  By 

Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia.
NMPA Seeks to Ensure Quality of Exports as China Becomes Key Supplier of COVID-19 Devices
China is stepping up efforts to ensure the safety and quality of exported medical devices. The actions come as countries around the world look to China for equipment for use in the detection, prevention and treatment of the pandemic coronavirus.
With the SARS-CoV-2 outbreak seemingly under control in China, at least for now, but still on the rise in other countries, medtech manufacturing plants in the Asian nation are shipping equipment related to COVID-19 to other parts of the world. Last month, China agreed to sell 2 million face masks and 10,000 pulmonary ventilators to Italy. Over the weekend, the United Kingdom government revealed it had sourced 300 ventilators from China.
The reliance on China provides the country with an opportunity to enhance, or tarnish, its reputation as a supplier of medical devices. Quality problems with medical devices shipped from China could cause lasting harm to the country’s reputation.
Chinese officials want to avoid that outcome. To do so, China’s National Medical Products Administration (NMPA) held a video and telephone conference to discuss the monitoring of the quality of medical device exports. NMPA wants its staffers to strictly implement requirements on the review and approval of medical devices, which the agency has overhauled in recent years to raise the standard of products sold in the country.
In geographic regions with high concentrations of exporters, NMPA plans to bring together people from different departments involved in the oversight of medtech manufacturers to form a joint supervision group. Manufacturers found to have fallen short of quality standards will be punished.
There have already been reports of Chinese products failing quality tests, although officials pointed to issues other than manufacturing shortcomings to explain those situations. Late last month, the Netherlands recalled 600,000 face masks. Asked about such reports in a press conference, an official said different standards and usage practices can explain some perceived quality problems.
NMPA Notice, More
TGA Expedites Review of COVID-19 Devices, Shares Clinical Trial Guidance
Australia’s Therapeutic Goods Administration (TGA) is expediting the assessment of medical devices involved in the detection, prevention and treatment of COVID-19. The expedited process is separate from the priority review pathway TGA uses to accelerate the progress of medical devices outside the pandemic context.
Medical devices, notably diagnostics, personal protective equipment and ventilators, have emerged as a key element of the fight to bring SARS-CoV-2 under control. As such, TGA is trying to ensure that devices associated with the coronavirus are rapidly assessed, leading it to ask sponsors to email it supporting technical files and data for assessment as soon as they submit an application. 
TGA shared details of the expedited regulatory processes on the same day as it disclosed how it is adapting its clinical trial notification (CTN) scheme to the pandemic. The Australian system allows trials to start without TGA acknowledging a CTN. However, some Approving Authorities and Human Research Ethics Committees do require a TGA acknowledgement prior to the start of a clinical trial.
In light of the risk that the wait for a TGA acknowledgement will slow development, the Australian regulator is asking organizations running COVID-19 clinical trials to contact it after submitting a CTN online. By registering a trial with TGA by phone or email, researchers can get the agency to prioritize their notifications.
As is happening in other countries, the proliferation of COVID-19 studies is one of two ways the viral outbreak is affecting clinical research in Australia. The other way relates to the disruption the virus, and how government responses to it may cause to clinical trials of products unrelated to COVID-19.
TGA accepts that the pandemic may cause deviations from trial protocols, for example because of product supply changes or the need to manage study participants remotely. Organizations forced to make such changes because of COVID-19 do not need to notify TGA. The agency still requires notification of variations that are not related to COVID-19.
TGA Notice, More
Philippines Moves to Bring Down Barriers to Personal Protective Equipment Imports
The Philippine Food and Drug Administration (FDA) is contributing to efforts to make more personal protective equipment available in the country. FDA is allowing donated masks, gloves and other equipment into the country without regulatory clearance and working with other agencies to clear bottlenecks to importation.
In describing the problem it is trying to address, FDA gave a blunt assessment of the situation faced by organizations trying to import devices into the Philippines. FDA said “bottlenecks and challenges in the importation process remain,” highlighting “confusion and misinformation” about importation procedures and the need for organizations to interact with siloed government agencies separately to get the greenlight to bring a product into the Philippines as problems.
As FDA sees it, the need to interact with multiple government agencies means delays or challenges at one step in the process can produce “a domino effect across the other import processing agencies, which becomes unduly burdensome to the importer.” FDA, the Bureau of Customs (BOC) and the Anti-Red Tape Authority want to spare importers from those burdens.
To do so, the government agencies have created the Bayanihan One Stop Shop (BOSS) to serve as a single point of contact for importers. Once an importation application is submitted to either FDA or BOC, the BOSS platform will prompt the agencies to act. A Viber group chat involving the agencies is in place to help the agencies keep track of applications.
FDA released details of BOSS shortly before it issued an advisory on the clearance of masks, gloves and related protective equipment. For imports for local commercial use, an importer’s License to Operate will typically be sufficient for customs release, according to FDA. Foreign donated devices can come into the country without FDA clearance.
FDA Notice, More
China Shares Draft Guidelines on Clinical Development of Humira Biosimilars
China’s Center for Drug Evaluation (CDE) has shared guidance for companies developing biosimilar copies of AbbVie’s blockbuster Humira. The draft guidance covers how to perform pharmacokinetic comparisons in healthy subjects and assess clinical effectiveness in patients.
Having held the title of top-selling medicine globally for several years, Humira is a major target for developers of biosimilars. Bio-Thera Solutions won approval for the first biosimilar copy of Humira in China late last year. The experience in other markets, notably Europe, suggests companies are likely to start selling rival products.
To support the development of such products, CDE has created clinical trial guidance focused on the assessment of Humira biosimilars. The guidance refers to general guidance on the clinical study of biosimilars, but also features points specific to Humira and the patients who take the drug.
Points specific to Humira discussed in the guidance include the criteria for selecting study subjects, such as the disease activity levels eligible for participation, and the dosing regimen they should take.    
CDE is accepting feedback on the draft throughout April.
CDE Notice (Chinese)
Other News:
TGA has issued a warning to advertisers about COVID-19 test kits. As TGA states, while certain rules have been relaxed to support the proliferation of diagnostics, the changes do not exempt companies from the advertising framework. That means ads for COVID-19 tests cannot be directed at consumers. TGA Notice


© 2023 Regulatory Affairs Professionals Society.

Discover more of what matters to you

No taxonomy