Asia Regulatory Roundup: Australia Proposes to Align Device Regulations With EU (1 August 2017)

Posted 01 August 2017 By Nick Paul Taylor

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Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia.

TGA Seeks Feedback on Proposed Alignment of Australian and European Medical Device Rules

The Therapeutic Goods Administration (TGA) of Australia is proposing to align parts of its medical device regulatory requirements with those in place in Europe. TGA is gathering feedback on plans to reclassify surgical mesh and place new requirements on manufacturers of implants with a view to then implementing the changes.

If the changes come into force as planned, TGA will reclassify surgical mesh devices as Class III. Today, surgical meshes, with some exceptions, are Class IIb. Raising the classification will force manufacturers with Class IIb meshes on the market to seek additional conformity assessment certification to up-classify their devices. Specifically, manufacturers will need design examination certification for each of their mesh devices. New applicants will follow the Class III pathway.

To smooth the transition from Class IIb to Class III, TGA is proposing a three-year implementation window. This will give companies until 30 November 2020 to apply to up-classify their devices or face having their meshes delisted. The window will start with a six-month period in which TGA expects manufacturers of Class IIb devices to notify it of their intent to apply for up-classification. Companies that do not notify TGA in this period must be covered by Class III entries.

TGA’s plans follow the approach set out in medical device regulations agreed upon in the European Union earlier this year. That means the TGA proposal will be familiar to manufacturers of surgical mesh devices, but TGA still wants to know if its plan will have unintended consequences and, if so, how it can mitigate them.

The agency is also seeking feedback on its second proposal, which affects makers of implantable medical devices. TGA plans to make manufacturers of orthopedic devices and other implants provide patient cards. These cards are intended to improve communication between doctors and their patients by providing details of any precautions either party should take, the forecast lifespan of the device and basic information about the product and its manufacturer.

This information goes beyond that currently mandated by TGA regulations. To gauge how the change will affect the industry, TGA has asked the same questions about unintended consequences as it did regarding surgical meshes, plus two queries specific to patient cards. TGA wants to know the best way to ensure cards reach patients and gather ideas about how to promote the provision of the cards. In the long term, TGA sees the information going into electronic health records.

The patient card proposal also copies incoming requirements in Europe. TGA committed to aligning its medical device regulations with those of Europe following the expert review. With the EU just enacting major changes to its medical device rules, that means TGA must now consider making the same revisions to its own framework. The surgical mesh and patient card proposals mark the start of this process.

TGA prioritized the proposals in the belief they will have a positive effect on patient safety. The agency plans to seek feedback on further alignments of the frameworks next year.    

Consultation Paper

Lawmakers Clear TGA to Share Information About IVDs With National Testing Authority

Australian legislators have empowered TGA to share information about in vitro diagnostics (IVD) with the National Association of Testing Authorities (NATA). The legislation is intended to facilitate the sharing of information about the safety, quality and performance of IVDs manufactured by NATA-accredited laboratories. 

The passage of the text into law clears TGA to share certain types of information with NATA, a body that assesses and accredits laboratories. Such sharing is seen as beneficial given the overlaps in the activities of TGA and NATA.

Legislators cited examples of these overlaps in examples of how TGA may use its new powers. One example describes how the sharing of information after TGA receives a notification about a Class I to III in-house IVD could help NATA prepare for an accreditation assessment of that laboratory. Another outlines a scenario in which TGA shares technical and scientific data about a reported adverse event that raises concerns about the “performance or competence” of a lab accredited by NATA.

The information shared in these examples falls into one of four categories covered by the law. The categories cover information on labs that make in-house IVDs, trends relating to in-house IVDs, concerns about the performance and competence of NATA-accredited labs and assorted other details about Class I to IV devices and post-market investigations and requirements. 

Legislation

CDSCO Adds Export NOC Module to Sugam Online Regulatory Filing Portal

The Central Drugs Standard Control Organization (CDSCO) has added a module for export no objection certificates (NOCs) to its online regulatory filing portal. CDSCO thinks the module will save exporters time and money.

Drug Controller General of India (DCGI) Dr. GN Singh mentioned plans to add the granting of NOC to drugs intended for export to the Sugam portal last month. Following a meeting of those affected by the module, CDSCO has now begun using the portal to handle NOC requests. Singh wants exporters to register on Sugam to use the portal.

The fast advance of the module from proposal to implementation — the rollout took place about a week after the meeting — suggests CDSCO may introduce a clutch of extensions to Sugam in quick succession.

DCGI disclosed plans to introduce the NOC module alongside four other proposed extensions covering  new drugs, fixed-dose combinations and subsequent new drugs. Meetings to discuss those modules took place within days of the session on NOCs.  

CDSCO Notice

CFDA Commits to Improving its Website After Evaluating Current Offering

China Food and Drug Administration (CFDA) has committed to improving its website. The regulator identified the need to increase the frequency with which the website is updated and make other improvements during an evaluation of its current offering.

CFDA’s focus on adding information to the website more frequently is in line with the priorities set by Bi Jingquan since he took over as head of the agency in 2015. Inheriting an agency that risked losing control of the narrative in the era of microblogging site Weibo, the CFDA chief created a public information center and website editorial department to monitor social media and update its website more frequently. 

The outcome of the self-inspection shows CFDA still has work to do in this regard. CFDA performed the quarterly inspection of its website as part of a government-wide program to assess and improve online resources.

CFDA Notice (Chinese)

Other News:

CDSCO has begun working with C-DAC to develop automation software for use in its laboratories. C-DAC, a governmental IT R&D organization, also worked with CDSCO to develop the Sugam online regulatory filing portal. The group faced criticism for its role in that project after “non-validation of the regulatory requirement” led to the portal failing to meet expectations. CDSCO Post

TGA has released a safety advisory on the use of gadolinium-based contrast agents in MRI scans. The agency is working with sponsors to add safety concerns to product documents and is asking healthcare professionals to limit use of the contrast agents. TGA’s actions follow EMA’s proposal to suspend the marketing authorizations of three gadolinium contrast agents. TGA Notice

The National Pharmaceutical Pricing Authority (NPPA) of India has revised the ceiling prices of some drugs. NPPA Notice

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Categories: Biologics and biotechnology, Drugs, Medical Devices, Government affairs, Regulatory strategy, Regulatory intelligence, News, Asia, CDSCO, TGA

Tags: Asia Regulatory Roundup, medical device regulations, online regulatory filing

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