Asia-Pacific Roundup: Medsafe seeks feedback on changes to clinical trial regulation

New Zealand’s Medicines and Medical Devices Safety Authority (Medsafe) is holding a consultation into planned changes to the regulation of clinical trials. Medsafe is seeking feedback on proposed revisions to an existing document and two new texts on specific aspects of clinical development.

The regulator last sought comment on a major revision to its guideline on regulatory approvals and good clinical practice requirements for clinical trials in 2018. Medsafe wants to update the document to add details of new or updated legislation and relevant guidance issued in New Zealand and overseas, reflect changes to best practices such as the involvement of patients in trial design and clarify requirements.

The changes include an expanded definition of clinical trial that includes additional criteria intended to help distinguish studies from usual clinical practice. Medsafe has proposed the changes to clarify the scope of the guideline and better align its position with international definitions.

The proposal is part of a set of changes intended to clarify requirements. Medsafe also wants to clarify the fee waiver eligibility criteria and application process, the requirements for labeling investigational medicines and the rule on reporting fatal or life-threatening suspected unexpected serious adverse reactions (SUSARs). Sponsors should report on such SUSARs within 15 days of learning of the event.

Medsafe wants to know if pharma companies and other clinical trial stakeholders agree with its changes. The request for feedback includes a question about whether people agree with Medsafe’s proposals to encourage patient-centric clinical trial design and conduct. Medsafe’s position is informed by the Council for International Organizations of Medical Sciences’ publications on the topic.

“Clinical trials should be designed with the best interests of patients in mind and should include the patient perspective (i.e., a patient-centric design). It is desirable to involve patients in the design of the clinical trial,” Medsafe said in the guidance.

The regulator published the updated document alongside two new texts, one about first-in-human and early-phase clinical trials and another about safety monitoring and reporting for investigational products. Medsafe’s draft guideline on early-phase trials is informed by the “greater level of uncertainty (and therefore risk)” associated with the studies because of the lack of experience with the molecules.

The guideline covers how to mitigate those increased risks using clinical trial sites with “appropriate facilities, procedures and staff expertise.” Medsafe expects sponsors to choose trial sites that are set up for close supervision and monitoring of study participants, have access to emergency equipment for resuscitating and stabilizing individuals and can handle investigational drugs.

It is highly desirable for the principal investigator to have postgraduate qualifications in an area such as clinical pharmacology or pharmaceutical medicine, Medsafe said, and staff with experience managing medical emergencies should be present on all dosing days.

The other new guideline provides additional information on the requirements for safety monitoring and reporting for trials involving investigational medicinal products and investigational medical devices in New Zealand. The guideline covers the responsibilities of the sponsor and other stakeholders. Reporting of safety issues in medical device trials is “preferred but not mandatory,” Medsafe said.

The documents are open for comment until 27 October.

Medsafe Notice

TGA cancels registration of 12 spinal cord stimulators after postmarket review

The Therapeutic Goods Administration (TGA) has canceled 12 spinal cord stimulator (SCS) devices from the Australian Register of Therapeutic Goods (ARTG) as part of its review of the safety and performance of the products.

TGA began the postmarket review in 2022 in response to emerging signals including increasing reports concerning the safety and performance of the devices. The administration asked all sponsors to provide it with information including evidence supporting the long-term safety of their products, which send low levels of electrical stimulation directly to the spinal cord to relieve pain.

As its review neared completion, TGA began removing some SCSs from the ARTG and putting restrictions on other devices. The canceled devices include four products sold by Medtronic. TGA took the action after the sponsor “provided insufficient information to demonstrate compliance with the essential principles.” The administration also removed eight devices distributed by RQSolutions in Australia.

The canceled devices are not being recalled and do not need to be removed from patients who have already received the implants. No new patients will receive the implants TGA removed from the ARTG.

TGA imposed restrictions on 70 other devices sold by companies including Abbott, Boston Scientific and Nevro. The administration has imposed new conditions of inclusion that “require the sponsor to provide additional information, such as additional studies, to the TGA at specified time points.” Sponsors may need to provide annual updates or limit the use of their devices to particular patient populations.

TGA Notice, More

India launches online portals for adverse drug monitoring and Pharmacopoeia

The Indian government has launched online portals for its adverse drug monitoring system (ADRMS) and to access Indian Pharmacopoeia (IP) standards.

IP shared details of the two portals after the Indian minister of health and family welfare launched them at a meeting last week. The organization called the ADRMS software “India’s first medical product safety database tailored to the needs of the Indian population” and set out its goals for the online portal.

“It will facilitate the users reporting of adverse events related to medicines and medical devices,” IP said. “This software will not only streamline the reporting process by patients/their caregivers and healthcare professionals but also empower Indian pharmaceutical industries/marketing authorizations holders to report adverse events through direct user gateway.”

The government launched the ADRMS software alongside an IP online portal that is designed to make it easier for people to access the Pharmacopoeia’s standards. Users can view “drug monographs seamlessly on their computers and mobile devices,” IP said, and that could help increase recognition and acceptance of India’s standards overseas.

“This enhanced accessibility is expected to extend the reach of the IP to a broad audience, ensuring that all stakeholders have easy access to vital information,” IP said. “The improved quality of content, coupled with online accessibility, is expected to facilitate the global recognition of IP, aiding Indian drug manufacturers in exporting medicines at a competitive cost.”

IPC Notice, More

DRAP warns of falsified propylene glycol batches with counterfeit Dow labeling

The Drug Regulatory Authority of Pakistan (DRAP) has published a rapid alert about falsified propylene glycol batches that have counterfeit Dow Chemical labeling.

Dow Chemical’s operation in Singapore and the World Health Organization told DRAP about the batches. The alert covers three batches, two purportedly from Dow Europe and one from The Dow Chemical Company. The labels are counterfeit and the quality and safety of this material cannot be assured, DRAP said. As such, DRAP is asking companies not to use the batches to make medicinal products.

DRAP’s regulatory field force has “taken possession of contaminated raw materials and commenced an investigation to trace the supply chain of these containers,” the regulator said. The authority is asking companies that used the affected batches to make medicines to analyze their retained samples immediately. If the sample is contaminated, the company should recall the affected products.

The notice is the latest in a series of DRAP alerts about propylene glycol in Pakistan.

DRAP Notice

Asia-Pacific Roundup: Medsafe seeks feedback on changes to clinical trial regulation

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