Asia Regulatory Roundup: TGA Mulls Regulatory Reforms for 3D-Printed Devices

RoundupsRoundups | 25 February 2020 |  By 

Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia.
TGA Mulls Regulatory Reforms for 3D-Printed Devices
The Therapeutic Goods Administration (TGA) of Australia has proposed introducing a comprehensive package of regulatory reforms in response to the emergence of custom-made medical devices. Under the proposed plan, TGA would form a framework for the regulated production of devices by healthcare providers and otherwise overhaul the rules covering the sector.
As TGA sees it, the rising complexity of personalized devices, the use of manufacturing techniques “well beyond” those envisioned by the authors of existing regulations and the forecast explosion in use of 3D-printed products means the government needs to act. TGA has spent the past two years talking to stakeholders about the form its action should take, leading to a regulation impact statement setting out three possible options.
The three options are to keep the current system, introduce comprehensive reforms or to regulate custom-made devices in line with other medical devices. TGA does not explicitly express a preference for any option. However, the agency states the comprehensive reforms are the product of a long consultation and have “strong stakeholder support,” while also pointing out the shortcomings of the other options.
If the comprehensive reforms go ahead, TGA will create new definitions for personalized devices, gain powers to inspect production sites, broaden its classification of products that record diagnostic images to include 3D-printed models of patient anatomy and otherwise change the rules covering the emerging field.
TGA thinks the changes would align its definitions with international standards, give patients more information about custom devices and enable healthcare providers to make personalized products without holding manufacturing or conformity assessment certifications.
The plan would add to the costs of stakeholders affected by the regulations and could have other knock-on effects, such as increased pressure on hospitals. TGA tried to analyze and quantify these effects, but the nascent nature of the sector hindered its attempts to make firm conclusions.
TGA was more unequivocal about the shortcomings of the two other options. The agency thinks maintaining the status quo will expose patients to “unmitigated potential for harm from an increasing number of medical devices that have insufficient regulatory oversight.” Regulating custom devices in line with other devices would address some flaws with the current system but leave TGA’s rules misaligned with international norms and compromise access to personalized products.
TGA Statement
India’s CDSCO Clarifies Application of new Drugs and Clinical Trial Rules
India’s Central Drugs Standard Control Organization (CDSCO) has clarified that its clinical trial rules do not apply to medicines that are not considered to be new drugs. CDSCO made the clarification as part of an update that also resolved uncertainty about how applicants should communicate details of the site where their medicines are manufactured and tested.
The frequently asked questions document published by CDSCO in 2018 states the rules are applicable “only for new drugs and investigational new drugs for human use,” adding that new veterinary drugs will continue to be covered by older regulations. However, CDSCO has continued to field “concerns” regarding the applicability of the clinical trial rules, leading it to update its FAQ document.
CDSCO’s update about the applicability of the rules affects one question. The FAQ now explicitly states that the rules do not apply to “drugs which are not considered as new drugs or investigational new drugs.”
Elsewhere in the FAQ, CDSCO made changes to two questions about bioavailability/bioequivalence (BA/BE) studies. CDSCO removed a statement that certain BA/BE tests must comply with “regulatory provisions prescribed under Chapter IV of the New Drugs and Clinical Trials Rules 2019.” The revised FAQ states the studies need “to be conducted with due approval of the respective ethics committee and other applicable guidelines in this regard.”
The other BA-/BE-focused change provides far more detail on how to apply for permission to make a new drug to test in such studies or clinical trials. CDSCO revealed the filing changes shortly before committing to processing applications to make new drugs for testing within seven working days. CDSCO also set a 15-day timeline for processing import and export applications related to BA/BE studies.
Finally, CDSCO added one new question to its FAQ. The answer provides a template that applicants can use to communicate details of the manufacturing sites where new drugs are made and tested.
CDSCO FAQ, Notice, More
CDSCO Delays Deadline for Filing FDC Data to 15 Months After Original Date
CDSCO has pushed back the deadline by which producers of certain fixed-dose combinations (FDCs) need to submit data to show their products are rational. The delay marks the third time CDSCO has given the affected manufacturers more time.
In December 2018, CDSCO contacted the manufacturers of 66 FDCs to ask for resources to inform decisions about the rationality of their drug combinations. At that time, CDSCO gave most affected manufacturers until the end of February to submit the requested information. A subset of companies had until the start of April to comply with the request.
Both deadlines passed without all the affected companies providing the information. CDSCO delayed the deadline in April and again in August. Now, CDSCO has delayed the deadline again “in view of representations received in the matter for extension of time for submission.”
CDSCO now expects to receive the information by the end of May. If companies fail to comply with the request, CDSCO warns a decision will be made on the basis of the available information. CDSCO made the same the threat at the time of its original request for information in 2018.
CDSCO Notice
TGA Tweaks Changes to Permissible Ingredient Warnings After Consultation
TGA has revised its planned changes to warnings on certain permissible ingredients in response to industry feedback. The agency softened its position on some of the ingredients in light of pushback.
Based on feedback from organizations including Complementary Medicines Australia (CMA), TGA made the most significant changes to its position on Withania somnifera, a plant used in traditional medicine. The final warning adds caveats absent from the original proposal that clear pregnant women to take the plant without consulting a health professional if it is prepared in certain ways.
TGA made smaller changes to other proposals, in many cases by giving the industry the option to use different wordings that convey the same meaning. CMA criticized the original warnings proposed by TGA for being “excessively and unnecessarily lengthy.”
The trade group also criticized TGA’s approach to the consultation. As CMA saw it, TGA presented the changes “almost as if they are pre-determined.” CMA argued the approach was “inflexible” and not in keeping with government guidelines.
TGA Notice
Other News:
Malaysia’s Medical Device Authority (MDA) has finalized its guidance on orphaned medical devices. MDA created the guidance to support the continued safe use of medical devices that are already in use but no longer have an operational manufacturer or authorized representative. The final guidance comes months after MDA released a draft version for consultation. MDA Notice
China’s National Medical Products Administration (NMPA) has approved three more products for detecting the novel coronavirus COVID-19. The approved tests rely on antibodies or nucleic acids to detect the virus. NMPA Statement (Chinese)
TGA has published data on the time it took to process medical device applications last year. TGA Report


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