Asia-Pacific Roundup: China outlines vision for national vaccine QMS

Regulatory NewsRegulatory News | 29 June 2021 |  By 

China’s National Medical Products Administration (NMPA) has shared plans for the next steps in the development of its vaccine regulatory quality management system. NMPA is calling on affiliated and provincial institutions to establish and connect their vaccine regulatory quality management systems to the national resource to create a unified network.
The Chinese regulator committed to overhauling the regulation of the vaccine supply chain in 2016 in response to a scandal involving the sale of improperly stored vaccines. A subsequent scandal focused on a Chinese manufacturer of rabies and DPT vaccines that was accused of problems including using expired active ingredients and forging data intensified the pressure on NMPA to improve oversight of the preventative products manufactured and used in China.
NMPA discussed its progress to date and the next steps at a management review meeting centered on the vaccine regulatory quality management system. The meeting reviewed the construction and operation of a system that NMPA sees as central to the assessment of vaccines, the standardization of regulation and the implementation of the State Council’s order to strengthen China’s regulatory capabilities.
The construction of the system has entailed the publication and implementation of 42 documents on vaccine regulatory procedures. NMPA published the texts, in part, to support the standardization of vaccine regulation and the consistency of decision making.
Work is now underway to extend the reach of the system to further those goals. NMPA wants the system to interact with related resources operated by provincial, municipal and county-level medical products administrations. The objective is to integrate every process into a coordinated and unified national vaccine regulatory quality management system.
NMPA is looking to its partners to help achieve that objective. The agency wants provincial-level medical products administrations and its affiliated institutions to establish and operate their own vaccine regulatory quality management systems. By connecting the systems to the national network, NMPA is aiming to create a unified vaccine platform and help the different groups work as one team.
NMPA Statement
TGA grants provisional approval to J&J COVID-19 vaccine, advances work on Moderna jab
Australia’s Therapeutic Goods Administration (TGA) has granted provisional approval to Johnson & Johnson’s COVID-19 vaccine. TGA disclosed the approval the day after it took an early step toward the approval of Moderna’s vaccine against the coronavirus.
J&J’s single-dose viral vector vaccine became the third COVID-19 prophylactic to win provisional TGA approval after the jabs from AstraZeneca and Pfizer. However, while Australia is currently trying to ramp up its vaccination campaign amid growing hesitancy and the emergence of outbreaks of cases across the country, the J&J shot is not currently included in the national immunization program.
The low uptake of COVID-19 vaccines in Australia partly reflects public concerns about AstraZeneca’s product and limited supplies of Pfizer’s jab. Approving other COVID-19 vaccines could increase the supply of products that the public is willing to use.
Moderna is working to bring its mRNA vaccine to the Australian market. TGA granted provisional determination to the vaccine last week, rendering the product eligible for provisional approval. The next step is for Moderna to apply for provisional approval. Australia has ordered 10 million doses of the current Moderna vaccine for this year and 15 million variant-specific booster shots for 2022.
TGA Notice, More
Philippine FDA posts guidelines on the licensing of medical device supply chain players
The Philippine Food and Drug Administration (FDA) has released guidelines on how organizations in the medical device supply chain can use its eServices Portal System to apply for a license to operate (LTO).
FDA has worked for more than one year to streamline the LTO process. The effort has now resulted in the publication of a document setting out how traders, wholesalers, importers and exporters of medical and health-related devices can apply to obtain, renew and update an LTO.
The guidelines detail the application requirements for each type of LTO submission and the evidence required to support them. Upon receipt of an application, FDA will conduct a pre-assessment and, if it accepts the submission, ask the applicant to pay the associated fees. Most of the guideline is taken up by annexes that provide a step-by-step guide to submitting via the online portal.
FDA released the guidelines alongside a draft text on the licensing of retailers of medical devices in the Philippines. The draft guidelines apply to outlets including retail stores, clinics and online platforms. FDA is accepting feedback on the draft until 24 July.
FDA Guidelines, More
China’s CDE provides notice of imminent launch of drug patent information platform
China’s Center for Drug Evaluation (CDE) has provided an update on its listed drug patent information registration platform. The platform has now completed preliminary testing, positioning CDE to put an important element of its planned patent linkage system into operation soon.
Information housed on the platform will serve as the basis for patent declarations for the marketing of generic drugs, traditional Chinese medicines and biosimilars. CDE sees the platform helping bring an early end to patent disputes. The system enables users to search for a patent number or the name of a drug or company.
CDE is looking to patent holders to populate the system. Having provided guidance on the disclosure of patents ahead of the testing of the platform last month, CDE asked marketing authorization holders to check the information last week. CDE wants patent holders that are yet to add information to do so as soon as possible.
CDE Notice (Chinese)
TGA publishes deadlines for making changes to ARTG entries
TGA has published the 2021 deadlines for making changes to the Australian Register of Therapeutic Goods (ARTG). The agency is asking companies that want to cancel entries to avoid paying annual charges in the 2021-22 financial year to do so by 30 June.
Sponsors of products that are no longer on the market need to cancel ARTG entries to be spared the fees associated with maintaining a registration. Once the deadline for canceling an entry passes, TGA will open a three-week window in which sponsors with turnover of AU$0 can seek exemption from the annual charge.
TGA will permit sponsors who miss the three-week window in July to apply to have their exemption restored until 15 September. However, sponsors who miss the window in July will need to make a late lodgement declaration and pay the associated fee. TGA will issue its annual charge invoices in August and expects payment by 15 September.
TGA Notice
Other News:
TGA has published its Pharmacovigilance Inspection Program metrics report for 2020. The report shows the number of inspections fell last year because of the pandemic-related four-month pause on in-person assessments. TGA completed six routine pharmacovigilance inspections that found two critical deficiencies related to the management of reference safety information. TGA Report
India has appointed 172 people as medical device officers. The responsibilities of the officers include the inspection of facilities that are seeking a license to manufacture Class C or D medical devices. The appointments were part of a flurry of notices issued by the government that also disclosed the names of more than 10 junior scientific assistants. Gazette Notification, More
TGA is running a survey to inform the redevelopment of its website. TGA Survey


© 2022 Regulatory Affairs Professionals Society.

Discover more of what matters to you