Asia Regulatory Roundup: China Releases Guidelines on Overseas Inspections of Device Companies

RoundupsRoundups | 08 January 2019 |  By 

Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia.
TGA Seeks Feedback on Planned Overhaul of Australian Medical Device Regulations
Australia’s Therapeutic Goods Administration (TGA) has begun consultations on proposed changes to several aspects of its regulation of medical devices. The consultations cover the planned introduction of a unique device identification (UDI) setup and other changes stemming from the European Union’s incoming medical device regulation.
After an independent review of TGA’s regulations in 2016, Australia committed to aligning its medical device rules with those in place in the EU “wherever possible and appropriate.” Since then, the EU has passed medical device regulations that are set to force significant changes on manufacturers and other organizations. TGA has responded to the changes taking place in the EU by publishing three documents for consultation.
The longest document addresses potential changes to certain definitions and the scope of Australia’s medical device regulatory framework. In most cases, TGA is proposing to harmonize legislation and regulation in Australia with the new EU definitions. The EU definitions of key terms such as “medical device” and “accessory” would supplant Australia’s current definitions under the TGA proposal.
However, in some cases TGA thinks factors such as the extent to which EU and Australian definitions differ make harmonization inadvisable. For example, TGA wants Australia to retain its definition of “sponsor,” as the EU defines the term far more narrowly. Whereas “sponsor” in Australia refers to an importer, exporter or manufacturer of therapeutic goods, in the EU the scope of the term is limited to clinical trials.
TGA wants people involved in the medical device industry to provide feedback on its changes to the definitions and explain how they will be affected by them. The agency also wants feedback on its approach to products without an intended medical purpose, the other topic addressed in the text.
One of the other documents covers the introduction of a UDI system. TGA wants to introduce a globally harmonized UDI system based on International Medical Device Regulators Forum guidance. The system would apply to all devices sold in Australia, with the exception of custom-made products and certain other technologies.
Some key questions remain unresolved, though. TGA’s early interactions with industry have revealed some people want the agency to develop and maintain the UDI database. This approach would give the public access to “core data elements” in the system but not commercial information. TGA wants to know if the rest of the sector wants it to take this approach.
The final consultation covers the reclassification of active medical devices for diagnosis and therapy, such as automated external defibrillators and closed loop systems. TGA is running the consultation to learn whether there is support for reclassifying any of these devices as Class III products. Currently, TGA treats automated external defibrillators and closed loop systems as Class IIb devices.
TGA is seeking feedback on the three consultation documents until 15 February.
Framework Consultation, UDI Consultation, Reclassification Consultation
Pharma Companies Call for TGA to Extend Transition to eCTD-Only Filings
Major pharmaceutical companies are pushing TGA to extend the phasing out of submission formats other than the electronic Common Technical Document (eCTD). TGA wants to finish the transition by the middle of next year, but companies with large portfolios of products want additional time.
In a proposal last year, TGA grouped different types of application into three pools and set transition timelines based on the extent to which the eCTD format is currently used. The industry is broadly supportive of the transition timeline for the first group of applications, which consist of new chemical entity filings and other submissions already filed in the eCTD format 95% of the time. However, some parts of the industry have objected to the transition timelines for the other two groups of filings.
Medicines Australia, an Australian trade group representing leading drugmakers, was among the organizations to speak out against the proposed TGA timeline. Whereas TGA proposed giving the industry until 1 October to use the eCTD format for major variations and other Stage 2 filings, the trade group wants to have until the start of 2020. Medicines Australia also wants six months longer than proposed to complete the move to the eCTD format for Stage 3 submissions.
GlaxoSmithKline, which requested the same timeline changes as Medicines Australia, articulated why it thinks extra time is required, particularly for global companies that are transitioning to eCTD in multiple parts of the world simultaneously.
“Preparing and planning for eCTD submissions, particularly for those types of applications included in Stage 2, can take a number of months, and it would be beneficial for sponsors to have ample time to facilitate the transition. As sponsors work towards transitioning to eCTD format for all prescription medicines, extending the transition timeframe will support a smooth transition to new processes with minimal business impact,” GSK wrote in its feedback to TGA.
However, while Medicines Australia and GlaxoSmithKline spoke with one voice on the timeline topic, other leading drugmakers had different opinions. Novartis said the timelines proposed by TGA are acceptable, AbbVie wants to merge the Stage 2 and 3 groups, and Johnson & Johnson requested more time for just the Stage 3 transition.
TGA plans to publish a summary of the outcome of the consultation early this year. The agency is yet to say whether it will acquiesce to Medicines Australia’s request but has disclosed that it will change the Stage 1 implementation date.
Consultation Responses
China Releases Guidelines on Overseas Inspections of Medical Device Companies
China’s National Medical Products Administration (NMPA) has published guidelines on inspections of overseas medical device manufacturers. NMPA created the guidelines to fulfill a government request to raise the standard of products imported into the country.
China has stepped up its oversight of overseas companies in recent years. In 2016, China identified a record number of foreign companies for inspection. The following year, China’s regulatory agency released a document intended to standardize its approach to the inspection of foreign manufacturing facilities.
Now, NMPA has added a device-focused document to expand beyond its earlier drug site inspection activities. The document clarifies that China’s overseas inspections will target R&D sites, in addition to manufacturing facilities, and covers how NMPA will handle companies that obstruct its activities.
NMPA Notice (Chinese)
TGA Revises Guidance on GMP Clearance of Overseas Manufacturing Facilities
TGA has revised its guidance on good manufacturing practice (GMP) clearances. The update provides additional information and clarifications to improve the guidance TGA released in 2017.
In creating version 18.1 of the guidance for overseas manufacturers that need GMP clearance, TGA has sought to address the perceived shortcomings of the previous text. Specifically, TGA has tried to clear up questions raised by the wording of version 18.0.
TGA has clarified that separate applications are needed for each unique site address in its database, and that there is no need to enter the names of specific cell lines in applications. Other clarifications cover when TGA will remove applications from the system for non-payment, and the criteria the agency uses in processes related to GMP clearances for the mutual recognition agreement pathway.
The latest version also features a fee table, additional information on extension applications and a new section on troubleshooting that explains what companies should do if they encounter certain common problems.
TGA Guidance


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