Asia-Pacific Roundup: TGA seeks feedback on aligning Australian essential medtech principles with EU

The Therapeutic Goods Administration (TGA) has begun a consultation into aligning Australia’s medical device essential principles with the EU’s medtech regulations.

Manufacturers must show their devices meet all relevant essential principles for safety and performance to sell their products in Australia. The principles, which are described in Australian legislation, include general considerations that apply to all devices, such as long-term safety, and considerations related to design and construction that are applied on a case-by-case basis. Another two principles cover clinical evidence and the information that is provided with a device.

TGA has compared the intent of the existing essential principles with general safety and performance requirements set out in the EU regulations on medical devices (MDR) and in vitro diagnostics (IVDR). The comparison allowed TGA to identify areas in which EU regulations add requirements to improve safety or performance, add clarity to the expectation of compliance or introduce terminology.

The administration has put forward 16 proposals for consultation. Most of the proposals describe plans to change existing essential principles but one covers the planned creation of principles related to three EU requirements. The requirements detail the need to reduce risks as far as possible without adversely affecting the benefit-risk ratio, the creation of risk-management systems and steps to eliminate or cut risks related to user error.

Officials singled out the impact of one proposal on IVD sponsors. The update would require sponsors to provide contact details for users to obtain technical assistance. TGA is proposing that sponsors would be required to have “appropriate agreements” with their manufacturers “to ensure technical assistance is provided to Australian customers.”

TGA is proposing a transition period for its updated requirements. Existing or new inclusion applications will have four years to comply with the revised essential principles. The proposed transition period for devices that are already included in the Australian Register of Therapeutic Goods is six years. TGA wants to know if affected companies agree with the proposed transitional arrangements.

The consultation also identifies aspects of the EU regulations that TGA is not planning to adopt. The lack of an equivalent Australian legislative framework on substances that are carcinogenic, mutagenic, toxic to reproduction or endocrine disrupting informs TGA’s decision to skip EU requirements on reducing the risks of substances released from devices and justifying the presence of endocrine disruptors. Similarly, TGA has left phthalate guidelines out because its principles cannot put obligations on the government.

TGA said adopting the proposals will provide clarity and consistency for manufacturers on regulatory expectations of compliance, simplify compliance for the more than 90% of devices supplied in Australia based on European manufacturer evidence, improve risk management and enhance product safety and performance.

The administration is accepting feedback until 16 October. TGA is holding webinars to give an overview of the consultation and field questions on 11 and 12 September.

TGA Consultation

DRAP shares draft guidelines on payments to healthcare professionals in Pakistan

The Drug Regulatory Authority of Pakistan (DRAP) has released guidelines on submitting details of spending on marketing toward healthcare professionals for consultation.

DRAP drafted the guidelines to “provide clarity and ensure compliance with the Ethical Marketing to Healthcare Professionals Rules 2021.” The rules cover forms of interaction between companies and healthcare professionals to support the rational use of drugs and ethical promotional practices. DRAP describes the principles of ethical interaction in the draft guideline.

The main section of the draft covers the submission of data and documents to DRAP. The 2021 text requires the head of the company to certify the business has complied with the ethical marketing rules each year. Each drugmaker has to provide a detailed summary of all spending on healthcare institutions and professionals.

DRAP expands on what information companies should submit in the draft, providing a template that drugmakers can use to share their spending on electronic and print media, samples, events and other marketing activities. Another template covers details of the beneficiaries of marketing spending.

The authority is asking companies to submit the spending templates as Excel files and the certificate of compliance as a PDF. Drugmakers should send the documents via email within three months of the end of their financial year.

DRAP is accepting feedback on the draft, which it uploaded on 9 August, for 15 working days.

DRAP Notice

TGA reorganizing guidance to make texts ‘more accessible and easier to navigate’

TGA is reorganizing its guidance after feedback from industry showed the “content needs much improvement to make it more user friendly.”

The Australian regulator has done user research on the guidance content of its website since 2023. The work has shown users find TGA guidance is difficult to navigate and find, suffers from a lack of clarity as to what the rules are and makes it hard to know what has been updated. TGA is addressing the feedback in changes intended to make the content easier to understand and navigate.

From September, TGA will reorganize its guidance “so it only includes content that is an explanation of the law and regulations on therapeutic goods.” TGA said the update will “make it clearer that guidance is about the rules you need to follow.”

The changes include new features such as improved page navigation so users “can easily jump to headings on long pages,” colorful indicators showing when content is new or updated and headings that can be bookmarked and shared. TGA will also provide clear descriptions of what has changed when it updates guidance and plans to phase out PDF and Word attachments to improve accessibility.

TGA Notice

Malaysia’s NPRA starts piloting reliance on reference agencies for label expansions

Malaysia’s National Pharmaceutical Regulatory Agency (NPRA) is running a 12-month pilot study as part of a push to expand regulatory reliance to cover applications for additional indications.

The pilot project covers label expansions such as new therapeutic indications, routes of administration and dosing regimens. Companies that have received authorization for the additional indication in one or more of NPRA’s reference agencies, which include authorities in the EU and US, can use the overseas registration to support an application in the Philippines.

NPRA is piloting a full reliance process for indications approved by one reference agency and a verification pathway for indications approved by two or more agencies. The agency estimates it will take 90 working days, after screening is approved, to process reliance applications for additional indications.

NPRA Notice

New Zealand’s Medsafe begins monitoring direct acting oral anticoagulant safety

New Zealand’s Medicines and Medical Devices Safety Authority (Medsafe) has started monitoring the risk of mood changes in people taking direct acting oral anticoagulant medicines.

Medsafe and the Centre for Adverse Reactions Monitoring (CARM) received a report of an elderly man who had anxiety, irritability and personality change after starting the anticoagulant rivaroxaban, which Bayer sells in New Zealand as Xarelto. CARM has received a small number of other reports of psychiatric changes associated with rivaroxaban use.

In response, Medsafe has begun reviewing the safety of the drug and other medicines in its class. The regulator is encouraging healthcare professionals and other people who see mood changes in people on the medicines to submit adverse event reports to CARM. The submissions will inform a review of the potential safety signal.

Medsafe Notice

Asia-Pacific Roundup: TGA seeks feedback on aligning Australian essential medtech principles with EU

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