Regulatory Focus™ > News Articles > 2019 > 9 > Asia Regulatory Roundup: TGA Seeks Feedback on Planned Changes to Medical Device Rules

Asia Regulatory Roundup: TGA Seeks Feedback on Planned Changes to Medical Device Rules

Posted 10 September 2019 | By Nick Paul Taylor 

Asia Regulatory Roundup: TGA Seeks Feedback on Planned Changes to Medical Device Rules

Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia.
 
TGA Seeks Feedback on Planned Changes to Medical Device Rules
 
Australia’s Therapeutic Goods Administration (TGA) is seeking feedback on two sets of medical device proposals. The proposals address essential principles for safety and performance and the regulatory requirements for medical device systems and procedure packs.
 
Both documents grew out of the Australian reform agenda sparked by the 2015 Expert Panel Review of Medicines and Medical Devices Regulation. In the case of the essential principles proposal, that reform agenda has manifested in a text that calls for changes to a fundamental aspect of medical device regulation that has remained constant since 2002.
 
Essential principles provide developers of medical devices of all types with a standard set of safety and performance requirements. Australia, following the lead of the European Union, adopted its essential principles in 2002 but changes since then have diminished their utility.
 
“Australia’s existing Essential Principles no longer align with international best practice, in particular in areas where there have been changes and advancements in medical technology such as software and other complex systems, medical devices incorporating new materials, advanced manufacturing methods, cybersecurity, human factors and information required for appropriate use of the device for the intended purpose by the user,” TGA wrote in its draft proposal.
 
In light of those shortcomings, TGA is proposing to incorporate EU General Safety and Performance Requirements and International Medical Device Regulators Forum essential principles into its take on the topic. That will change TGA’s position on topics including risk management, software, the use of devices by lay people and implantable technologies.
 
TGA has put forward other sets of proposals intended to address different limitations of its current essential principles. Those changes will clarify multiple sections of the principles, including the need to factor in ethical considerations around privacy and artificial intelligence, and call for companies to provide Australian Register of Therapeutic Goods (ARTG) numbers with devices, even if it is software that sells without physical packaging.
 
The second, separate consultation addresses assemblies of medical devices, such as implantable ventricular circulatory assist systems, and procedure packs that feature medical devices alongside other products. A first aid kit is an example of a procedure pack.
 
Australia has existing rules for such products, but TGA thinks they have weaknesses, particularly in relation to a rule that allows companies to classify multiple devices sold together under a single entry in the ARTG. TGA thinks the criteria and application of that rule are unclear, leading it to propose the addition of new definitions and revised requirements.
 
TGA is accepting feedback on both consultations until 17 October.
 
Principles Consultation, Systems Consultation
 
After WHO Acceptance, Pakistan Drafts Pharmacovigilance Guidelines
 
The Drug Regulatory Authority of Pakistan (DRAP) has published draft pharmacovigilance guidelines. The document provides a basic framework for pharmacovigilance in an attempt to operationalize the monitoring of drug safety in Pakistan.
 
Pharmacovigilance practices are less well-established in Pakistan than in many other parts of the world. Last year, Pakistan became the 134th full member of the World Health Organization (WHO) Programme for International Drug Monitoring (PIDM). Countries including Liberia, Niger and Sudan joined WHO-PIDM before Pakistan.
 
Having entered the program, Pakistan is now working to improve its pharmacovigilance operation. In the guidelines, DRAP cites the creation of the Pakistan National Pharmacovigilance Centre (PNPC) and the encouragement of healthcare professionals to report adverse events among its near-term goals. In the longer term, DRAP wants to make adverse event reporting mandatory and detect safety signals in its pharmacovigilance database.
 
The guidelines provide an overview of the infrastructure that will help DRAP work toward its near and longer-term goals. In the text, DRAP describes PNPC and the Pharmacovigilance Risk Assessment Expert Committee, as well as the interactions of these and other organizations and the functions of people who will work at them.
 
DRAP also sets out what it expects of different groups affected by pharmacovigilance, including the holders of drug marketing authorizations. The agency expects these companies to establish systems for managing pharmacovigilance activities and nominate qualified persons to maintain the systems and communicate with PNPC.
 
DRAP is accepting feedback on the draft guidelines via email.
 
Draft Guidelines
 
China’s CDE Moves to Improve Communication With Drug Developers
 
China’s Center for Drug Evaluation (CDE) has outlined a series of measures intended to improve its communication with biopharma companies. The changes include the introduction of times when CDE officials are available for face-to-face interactions with drug developers.
 
The level of regulatory support offered in China is one of the areas the country has historically lagged behind the European Union and United States. CDE, operating against a backdrop of a broader move toward a more amenable regulatory environment, has set out several ways in which it is working to ensure drug developers can access and submit information.
 
The creation of the aforementioned face-to-face communication channel at set times of the week is one of several initiatives detailed by CDE in a statement this week. CDE is also providing access to a computer that is configured to help organizations access and upload information. Finally, the agency has established a written communication channel.
 
CDE has established timeframes for responding to requests received via the written communication channel. In some cases, the requests will lead to a teleconference meeting. 
 
CDE Notice (Chinese)
 
TGA Proposes Regulating Folate When Marketed as a Medical Food
 
TGA has proposed regulating products containing folate substances as therapeutic goods if they are marketed for use in medical contexts. The change would require manufacturers of certain foods to register or list their products on the ARTG.
 
Folate is a vitamin found naturally in a wide range of foods. Some foods, such as dark green leafy vegetables and black-eyed peas, contain particularly high levels of the vitamin. Companies can supply these foods, and products containing them, in Australia without complying with the regulations on therapeutic goods. However, TGA is concerned about how some folate products are promoted.  
 
The concerns center on products that TGA describes as “purported to be foods for special medical purposes.” TGA singled out the promotion of products for therapeutic use relating to depression, an inborn error of metabolism or folate deficiency as examples of the practice.
 
In TGA’s view, products that are promotions for use in those contexts should be in the ARTG and subject to the regulation that entails. That position led to a draft order stating that products that contain a form of folate and “are represented as being food for special medical purposes, or being for dietary management of a disease disorder or medical condition” are subject to rules on therapeutic goods
 
TGA is seeking feedback on the proposal, including details of how it would impact different groups. The agency acknowledged that requiring the registration or listing of products on ARTG could affect patient access. However, TGA thinks patients could still access products via authorized prescriber or special access schemes during any disruption.
 
TGA Notice, Draft Order
 
Other News:
 
TGA has published information about its new template for Consumer Medicine Information (CMI). The agency revised the CMI in response to concerns that the old template resulted in documents that were too complex and hard to read. While the template is now in place, TGA thinks it will be “some time” before consumers see CMIs that follow the new format. TGA Notice

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