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Regulatory News | 31 October 2017 | By Nick Paul Taylor
Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia.
The Therapeutic Goods Administration (TGA) is planning to tighten oversight of autologous cell and tissue products. TGA’s proposed changes will bring some therapies under the biologicals regulatory framework, ban direct-to-consumer advertising and generally move Australia more in line with the US and EU.
Autologous cell and tissue products are therapies based on materials taken from and administered to the same patient. Historically, TGA has seen such therapies as part of medical practice and left the sector to regulate itself. The rise of direct-to-consumer advertising of unproven cell therapies and safety concerns tied to how the materials are manipulated have forced TGA to reevaluate its position.
The proposals put forward by TGA reflect these concerns. TGA plans to ban direct advertising of autologous cell and tissue products to consumers, much as it prohibits the promotion of medicines already. However, the agency will leave facilities free to promote services, provided they make no mention of specific products.
That graduated approach to regulatory oversight is evident in other parts of the proposals. TGA will exempt from regulation products that are made in a hospital by a healthcare professional for the treatment of a patient in their care. All other products will be regulated by TGA to some extent.
Products that are made and used outside an accredited hospital, undergo more than minimal manipulation or are intended for non-homologous use will fall under the biologicals regulatory framework. TGA is proposing an intermediate level of regulation for products that fall between these extremes, such as those that are minimally manipulated. The agency will introduce regulation for these products but offer exemptions from some requirements.
Australian officials plan to introduce the changes early next year. A transition period is planned to give providers time to align their operations with the new way of working. In parallel, TGA is writing guidance to help the industry to interpret the requirements and its staff to enforce them. TGA will seek feedback on these documents in the months to come.
That consultation will mark the third time in recent years that TGA has sought feedback on aspects of how to handle autologous products. The agency ran consultations in 2015 and 2016, responses to the latter of which were published this week.
Those responses include many letters from patients and providers objecting to the idea of banning the advertising of stem cell therapies. The patients had positive experiences with such treatments after learning about them via promotions on the radio and in other mediums. Providers will now have to take care to only advertise the service, not the product, when creating such promotions.
TGA Statement, Consultation Responses
TGA is set to reclassify surgical mesh products as Class III medical devices as part of a suite of changes affecting implantable products. The change to the classification of surgical meshes will force new products to clear a higher evidence bar to come to market after 1 December 2018.
Manufacturers of surgical mesh devices already on the market will benefit from a transition period to the new regulatory regime. TGA is giving manufacturers of existing urogynaecological devicesuntil December 2020 to file to reclassify their implants. Manufacturers of other surgical meshes have until December 2021. Once the transition is complete, all of the devices will be categorized as Class III products.
TGA’s actions come 21 months after the US Food and Drug Administration (FDA) issued a final order reclassifying surgical meshes as Class III devices. FDA gave manufacturers of existing devices 30 months to file a premarket approval (PMA) application. New products can only come to market following a PMA.
The Australian regulator unveiled its changes to the oversight of meshes alongside revisions to the rules covering all implants. After 1 December 2018, manufacturers of new urogynaecological mesh devices and permanently implantable products will need to provide a patient information leaflet. TGA is giving manufacturers of existing meshes and other implants until December 2019 and 2021, respectively.
TGA is bringing in the leaflets to ensure patients have access to information on the risks and benefits of implants before undergoing procedures. A perceived lack of information was one of the things to emerge from TGA’s discussions with patients.
The agency gathered views on the leaflets and reclassification of surgical meshes earlier this year. TGA received the broad support of trade group Medical Technology Association of Australia and the companies it represents, such as Johnson & Johnson.
TGA Statement, Consultation Responses
The China Food and Drug Administration (CFDA) has released a clutch of documents to continue its implementation of the government’s reform agenda. The latest batch of documents covers CFDA’s proposed changes to China’s drug administration act and the registration of clinical trial sites.
CFDA has moved quickly to enact changes since the State Council put forward proposals based on the agency’s own vision for the future of drug regulation in China earlier this month. The first text from CFDA emerged the day after the State Council’s proposals. Now, CFDA has released a more substantive set of draft documents to keep the reform agenda moving forward.
The changes to the drug administration act are among the most far-reaching of those put forward by CFDA. If adopted, the amendments would support the build out of CFDA’s cadre of professional inspectors. CFDA wants to pair this expanded oversight force with stronger punishments for people found guilty of breaching its rules. Ten-year bans from the industry are one suggestion.
Work still needs to be done to bring CFDA’s documents in line with the State Council’s vision of a faster regulatory system that encourages the development and adoption of innovative products.
CFDA is moving toward this vision on multiple fronts. Two of these initiatives took a step forward this week with the publication of draft changes to the registration of clinical trial sites and the drug and medical device approval system.
The agency is currently accepting feedback on all its recently released draft changes.
Draft Act, Registration Draft,Trial Draft (all Chinese)
CFDA has included products from AstraZeneca, Bristol-Myers Squibb and Johnson & Johnson in its latest clinical trial data verification drive. The agency initiated the probes as part of its ongoing attempt to identify and weed out applications based on substandard or fraudulent data.
In keeping with CFDA’s earlier assessments, the list of trials set to be evaluated by the regulatory agency is skewed toward those supporting the importation of drugs from multinational companies.
Eight of the 42 items on CFDA’s list relate to selexipag, a pulmonary arterial hypertension therapy J&J acquired in its takeover of Actelion. Another four items relate to dapagliflozin. AstraZeneca and Bristol-Myers developed the SGLT2 inhibitor for use in the treatment of diabetes and submitted filings for it to CFDA earlier this year. Another Western company, The Medicines Company, is also on the list.
Earlier batches of companies selected for data verification have featured the same types of drug developers. AstraZeneca, Bristol-Myers and J&J have all been through the process before. On those occasions, the companies were reviewed alongside peers such as Merck and Sanofi.
CFDA Notice (Chinese)
Tags: Asia Regulatory Roundup, autologous cell products, surgical mesh