Asia-Pacific Roundup: Japan’s PMDA translates advice on using e-consent technologies in clinical trials

Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) has translated a document about the use of “electromagnetic means” to get informed consent from participants in clinical trials and postmarket studies.

The document, the Japanese version of which was published in March, provides points for sponsors to consider about the use of electronic informed consent technologies. E-consent technologies provide an alternative to paper-based processes and, in the view of advocates for the digital approach, can improve subjects’ understanding of studies and streamline the process of obtaining consent.

Like other digital clinical trial technologies, e-consent benefited from increased interest as the pandemic prevented sites from performing their normal processes. Technology eliminates the need for talks about what the study entails to happen in person.

PMDA outlined the current state of the technology in its points to consider document, explaining that sites can present informed consent materials to potential trial participants on PC screens, tablets, videos and other electronic formats. The guidance then summarizes what sponsors should consider when using the technologies in their clinical trials.

When using e-consent, sites should provide potential participants with the same level of explanation and chance to ask questions as they have under paper-based processes. PMDA expects participants to be “adequately given an explanation from all perspectives related to the subjects’ participation in clinical trials.” A mix of older methods, such as in-person talks, and technology is acceptable to the agency.

While the end goal of informing potential subjects is unchanged, the use of technology requires sponsors to consider new barriers to achieving that objective. PMDA’s guidance advises sponsors to consider the level of familiarity with communication devices among the targeted population, as well as to assess the impact of health conditions such as impaired vision and motor function on their ability to give consent.

The guidance flags up a concern with reliance on self-learning processes to inform patients about clinical trials, noting that they “may increase differences in the level of understanding among subjects.” Because of that concern, PMDA is recommending that sponsors combine the technology with face-to-face talks or conversations over video calls, based on the level of understanding of subjects.

PMDA Document

Malaysia’s MDA shares draft guidance on importing medical devices for personal use

The Medical Device Authority (MDA) is seeking feedback on draft guidance about importing personal use medical devices into Malaysia. MDA created the guidance to inform compliance with a 2016 order that exempted certain medical devices from registration and establishment license requirements.

Under the 2016 order, medical devices are exempted from registration if they are imported for personal use, a term that is defined as “use of a particular individual only and not to be placed in the market.” The draft guidance expands on the information provided in the order with additional information about the limitations of the exemption.

MDA will grant exemptions to home-use medical devices imported by patients or their immediate family. The draft guidance prohibits the importation of devices that have a “brand, similar design, technology and mode of operation in the Malaysian market” and states that original packaging should be used when possible. Other terms cover the routes of importation and the quantity that is acceptable.

The draft features three annexes that provide examples of acceptable and unacceptable personal use imports, a regulatory framework for getting devices to the user and a declaration form for use by people bringing products into Malaysia. The examples explain that 500 COVID-19 self-tests is an “unreasonable” amount of kits to import under the personal use rule and that professional-use devices are prohibited.

MDA is accepting feedback on the draft until 14 August.

MDA Notice

New Zealand seeks feedback to inform regulation of psychiatric medicine clozapine

The New Zealand Medicines and Medical Devices Regulatory Authority (Medsafe) has started collecting feedback from the prescribers and users of clozapine to inform its approach to the psychiatric medicine.

Medsafe said it is conducting the survey because, while “many people have significant benefits” from the medicine, treatment with clozapine can “cause some significant side effects.” The agency said, “People who take clozapine and the healthcare professionals who support them may experience challenges with clozapine use.” Low neutrophil count is the most frequently reported adverse reaction in New Zealand.

Recently, New Zealand’s Medicines Adverse Reaction Committee (MARC) told Medsafe there is a lack of evidence to support a change in the hematological monitoring of patients taking clozapine. Yet, MARC also recommended that Medsafe review topics including the benefits and risks of the medicine.

The survey is part of the review. Medsafe is addressing different questions to patients and different sets of healthcare professionals, such as medical doctors and nurses. The questions for patients and their caregivers address topics such as the communication of side effect information, whether the patient suffers from constipation and how frequently they undergo blood tests.

There is overlap between the questions aimed at patients and healthcare professionals, with the survey of medical doctors also addressing side effects, constipation and blood testing from a different angle. Medsafe is accepting responses to the survey until 6 October.

Clozapine Survey

Indonesia’s BPOM meets with US FDA official to discuss oversight of online medicine sales

The Indonesian Food and Drug Authority (BPOM) has met with an overseas official to discuss the distribution of medicines through online channels and other informal markets.

Harinder Chahal, senior health policy and research advisor at the US Food and Drug Administration, took part in the meeting with BPOM. The Indonesian regulatory agency said the meeting addressed the work of the World Health Organization (WHO) to support the supervision of the distribution of medicines through informal channels. Chahal represents the US on a WHO falsified medicine working group.

The US has taken the lead on a recently adopted WHO priority on substandard and falsified medicines. The priority covers the development of “strategies for national regulatory authorities to mitigate public health risks posed by the distribution of substandard and falsified medical products through informal markets.” Indonesia voiced support for WHO’s plan in February and asked for help.

“We request the WHO to support Member States in ensuring the integrity of raw materials and healthcare products throughout the supply chain and in developing measures and strategies to boost capacities to monitor raw materials and ensure the quality of finished products,” the Indonesian delegation to WHO wrote. The request follows adverse events linked to contaminated cough syrup.

BPOM Notice (Indonesian)

Novo Nordisk notifies TGA about shortage of emergency diabetes medicine in Australia

Australia’s Therapeutic Goods Administration (TGA) has published an alert about a critical shortage of Novo Nordisk’s emergency diabetes medicine GlucaGen HypoKit.

The medicine treats people with type 1 diabetes who are unconscious because of extremely low blood sugar by triggering the release of sugar from the liver. People with type 1 diabetes, as well as their caregivers, keep the medicine on hand for emergency use.

Novo attributed the shortage to manufacturing delays that it expects to last until at least the end of September. TGA has approved the supply of overseas-registered glucagon products to mitigate the impact of the shortage and has formed a group to manage the situation.

TGA Notice

Asia-Pacific Roundup: Japan’s PMDA translates advice on using e-consent technologies in clinical trials

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