Asia-Pacific Roundup: China’s NMPA publishes annual report showing surge in activity in 2020

RoundupsRoundups | 22 June 2021 |  By 

China’s National Medical Products Administration (NMPA) has published its annual drug evaluation report for 2020. The report describes sharp increases in the number of applications processed by the regulator during the pandemic-affected year.
NMPA completed 8,606 registration applications requiring technical review, up from 6,817 the previous year. The activity contributed to the backlog of applications falling to 4,882, down from its peak of almost 22,000 in 2015. NMPA completed the reviews while also processing 56% more clinical trial applications than in 2019. New drug approvals rose 27%.
The agency was unable to complete all tasks within the mandated timeframes, though. Delays were common in the processing of new drug applications, although by December the completion rate had risen to more than 80%. NMPA said completion rates in general have significantly improved.
NMPA Report (Chinese)
TGA updates guidance on reporting medicine shortages after portal enhancements
Australia’s Therapeutic Goods Administration (TGA) has updated its guidance on medicine shortages to reflect enhancements to the portal form and report database.
The updates reflect enhancements to the TGA Business Services (TBS) portal form and Medicine Shortage Reports Database in the first major revision of the document.
Australian rules require sponsors to submit medicine shortages through the TBS portal. The updated guidance includes a link to detailed instructions on completing the TBS portal form, as well as details of the minimum information required on critical, time-sensitive notifications. The TBS notification form uses red asterisks to identify essential information such as the impact and nature of the drug shortage.
TGA publishes all shortages and discontinuations of reportable medicines on the Medicine Shortage Reports Database part of its website. The guidance describes the database as “the key tool for delivering consolidated information to support health professionals and consumers when there is a temporary or permanent disruption to the supply of a medicine in Australia” and provides details of how users can receive alerts of updated shortage information via email or RSS.
Information such as the nature of the shortage and the sponsor’s nominated public contact details is visible via the database. The guidance explains how long the information remains in the database. TGA leaves shortages that have been fixed in the resolved section of the database for three months. Details of discontinuations are visible for one year after the product is removed from the market.
Sponsors still have communication responsibilities after a shortage is reported and added to the TGA database. As the guidance explains, sponsors need to contact state health departments, professional bodies and other groups, depending on the nature of their products, when a medicine is affected by a critical shortage or discontinuation. The communication requirement can apply after a notice has been published in the database of shortages. 
TGA Guidance
TGA revises personalized medical device guidance to reflect new framework
TGA has revised its guidance on personalized medical devices. The new document, which applies to 3D-printed devices, features changes that reflect the commencement of the regulatory framework in February and updates to the legislation.
TGA published the first version of the guidance in November, prior to the commencement of the new regulatory framework for personalized medical devices. With the framework now in effect, TGA has released the third version of the guidance. TGA has restructured and rewritten large sections of the text.
The new guidance starts with a history of the regulation of personalized medical devices in Australia, before going on to explain the definitions established by the new rules. TGA has revised and expanded the definitions it established in the older versions of the guidance.
Some of the definitions are now accompanied by examples, such as the explanation of a specified design envelope through a discussion of a podiatrist who makes patient-matched therapeutic insoles. The specified design envelope encompasses the minimum and maximum dimensions, performance limits or other relevant factors that characterize a device for production purposes or are based on a template.
TGA released the updated guidance after convening a workshop involving seven peak professional and industry bodies representing the dental and oral health sector. The agency held the event to talk about the implementation of the regulatory framework for personalized medical devices.
TGA Guidance, More
TGA seeks feedback on changes to ARTG inclusion process for Class I medical devices
TGA is seeking feedback on changes to the process for including Class I medical devices in the Australian Register of Therapeutic Goods (ARTG).
The inclusion processes for Class I non-measuring, non-sterile medical devices and Class I in vitro diagnostics (IVDs) changed late last year. TGA extended the changes to Class I export only and Class I IVD export only medical devices last month. The agency summarized the changes last week as part of a request for feedback.
TGA is asking sponsors of Class I medical devices to complete an online survey. The survey covers questions about changes including the revised Class I Declaration of Conformity template that TGA implemented as part of an attempt to prevent misclassifications and ensure applications are accurate and complete. TGA is accepting feedback until 1 October.
TGA Notice
India’s NPPA explains impact of change to tax rates on drug price controls
India’s National Pharmaceutical Pricing Authority (NPPA) has clarified how changes to tax rates affect the maximum retail prices (MRP) of medicines that are subject to price controls.
Citing the Drugs (Prices Control) Order, 2013, NPPA said the MRP is inclusive of tax. As such, cuts to taxes should be reflected in lower prices. NPPA wants the benefits of changes to Indian tax rates to be passed on to the consumers of medicines. The agency is asking all companies to revise their prices in line with the tax changes.
NPPA has spared companies from the need to necessarily recall, relabel or re-sticker products that were distributed under the old, pre-tax rate adjustment MRP. Manufacturers can leave the products on the market with the old MRP if they can ensure retailers only sell them at the new, lower price. NPPA said companies can issue revised price lists to ensure compliance with the new MRPs.
NPPA Notice
Other News:
Regulatory officials from China and Japan have met to discuss the implementation of guidelines from the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). The agenda for the 18 June event covered ICH guidelines on clinical trials, quality, cell therapies and real-world data. PMDA Notice
TGA and the Australian Health Practitioner Regulation Agency have clarified the rules on promoting COVID-19 vaccines. The agencies issued the statement after TGA’s initial notice sparked a number of requests for clarification from healthcare professionals and their representatives about how the rules relate to guidelines on the promotion of regulated health services. Joint Statement, More
China’s NMPA is seeking feedback on two specifications for drug traceability. NMPA is accepting feedback on the specifications, which are part of its effort to promote the construction of a drug information traceability system, until July 20. NMPA Notice (Chinese)
TGA has issued a warning about counterfeit versions of Novartis’ Somatropin human growth hormone. TGA Notice


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