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Regulatory News | 02 January 2018 | By Nick Paul Taylor
Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia.
Australia’s Therapeutic Goods Administration (TGA) has adopted guidance on its priority review pathway for medical devices. The adoption of the guidance allows developers of highly promising devices aimed at serious unmet needs to jump to the front of the queue when they file for approval.
Devices must meet three criteria to be granted priority review status. First, the device must be used in the monitoring, treatment, prevention or diagnosis of a life-threatening or seriously debilitating condition. Second, that condition must be an unmet need. Third, the device must be a breakthrough technology, offer a major clinical advantage over existing products or, in the case of in vitro diagnostics (IVDs), result in a major public health benefit if it reaches the Australian market early.
TGA breaks apart how applicants can show their devices can meet these criteria in the guidance. This is straightforward for some criteria. To show a device is aimed at a serious condition, applicants must present objective and quantifiable medical information and analysis.
For other criteria, the process is more involved. Applicants have two routes to showing the targeted indication is an unmet need. Specifically, applicants can either show they have a first-of-its-kind device or one supported by “substantial evidence” that it offers a “significant improvement” over existing products.
Either way, TGA expects to see a discussion of the current cutting-edge approaches in the particular field, including a comparison between the experimental device and existing products or an explanation of the steps the applicant took to show no similar devices are available. This entails showing how the experimental device may offer improved performance, a better safety profile or expand the treatable patient population.
There are overlaps between this section and the evidence required to show TGA a device meets the third criterion. TGA is demanding succinct summaries of evidence showing the magnitude of the improvement in safety or performance, the impact on patient outcomes and how the results fare against standard of care.
The guidance fleshes out how applicants can show their devices deliver such improvements, as well as the third route open solely to developers of IVDs. The IVD-only route focuses on the public health benefits of bringing tests to market early in Australia. TGA expects companies to show how their IVDs improve on the sensitivity and specificity of existing tests by presenting data on endpoints, predictive values or likelihood ratios.
Companies seeking to gain priority review designation must pay a AU$9,660 ($7,574) application fee. Successful applicants will have six months to file for approval. After that, the designation lapses and the company must reapply for the priority review status. TGA will reassess applications to renew lapsed designations against the same criteria as original filings, as the competitive landscape may have changed since it first awarded the priority review status.
Australia’s TGA has established criteria for identifying comparable overseas regulators. The criteria provide a framework for determining which regulators are sufficiently similar to TGA to make work sharing and the reuse of existing overseas assessments viable.
TGA’s existing interest in collaborating with overseas regulators and making use of the assessments they generate increased after the 2015 expert review of its practices and processes. This led TGA to pay more attention to how it identifies regulators with standards similar enough to its own to make such collaborations viable and effective.
The result is a guidance document that breaks the assessment down into two sets of criteria. The first set of criteria seeks to show, “There is sufficient similarity between TGA and the overseas agency to support collaborative work.” This is achieved through assessments of whether the agency handles pharmacovigilance, good manufacturing practices, transparency and other activities in ways similar to TGA. The first set of criteria also determine whether TGA has a formal cooperation agreement with the overseas agency, its use of international standards and whether it produces reports in English.
TGA’s second set of criteria focus on specific cases of cooperation with agencies that have already been shown to be comparable overseas regulators. This stage gets into details such as whether the assessment report generated by the overseas agency is unredacted and whether the medicine seeking approval in Australia is identical to that reviewed elsewhere. TGA also wants to see that the report is generated in a format and using a methodology that are consistent with its own.
“A key consideration is whether the assessment reports have the required scope. For example, in the case of clinical assessments, we would consider what studies and analyses have been included, and for each of these, the data cut-off for analysis,” TGA wrote.
As it stands, TGA views five countries — Canada, Singapore, Switzerland, the United Kingdom and United States — as comparable. The agency also views one transnational jurisdiction — the European Union — as comparable.
The China Food and Drug Administration (CFDA) has released draft guidance on the reporting of adverse events by marketing authorization holders. CFDA has followed international standards by proposing to give companies up to 15 days to report serious adverse events.
That puts CFDA’s proposed timeline in line with those used in the US and Europe. CFDA is proposing tighter timelines in some areas, though. The Chinese regulator plans to give companies 30 days to report less serious adverse events. That compares to a 90-day reporting window for non-serious adverse events in the European Union. CFDA also wants companies to immediately report adverse reactions that cause serious harm or death.
The guidance tasks companies with improving their ability to gather adverse event reports. This entails establishing programs that capture reports of adverse events from doctors, pharmacists and patients, as well as from academic literature and other repositories of information.
CFDA expects companies to pair these enhanced data collection capabilities with analytic processes that enable the proactive identification of potential risks associated with their products.
The agency is proposing to severely punish marketing authorization holders that fail to meet the adverse event reporting requirements. Fines and the suspension of marketing authorizations are among the punitiative measures being considered by CFDA. Individuals may also face punishment for their role in any wrongdoing.
CFDA is accepting feedback on the draft until the end of the month.
CFDA Guidance (Chinese)
The Drug Controller General of India (DCGI) has stopped accepting paper-based applications for human vaccines. DCGI Dr. GN Singh made the switch to a fully online approach on 1 January.
The action means companies seeking approval to run clinical trials, sell or import human vaccines need to use the online Sugam portal. India began using Sugam for some regulatory processes in 2015 but it has held off on forcing applicants to use the portal for some important filings. The switch to a fully online system for human vaccines is part of a phased end to this intermediate approach.
India sees value to regulators and industry in moving processes online. The expansion of the use of Sugam and planned integration with existing state-level portals are intended to enable the realization of this value.
Tags: Asia Regulatory Roundup, device priority reviews, overseas regulators