Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia.
New Zealand Adopts Major Revision to Clinical Trial Rules Following Positive Feedback
The New Zealand Medicines and Medical Devices Safety Authority (Medsafe) has revised its guideline on clinical trials. Medsafe adopted the major reworking of the earlier guideline after its draft revisions received mostly positive feedback from drug developers during a recent consultation.
AbbVie, Boehringer Ingelheim, Roche and big biopharma trade group Medicines New Zealand were among the 20 people and organizations to submit feedback on the draft Medsafe released in June. The industry respondents were broadly supportive of the changes proposed in the draft. AbbVie summed up its position by stating, “The revised guideline is of good quality with only a few specific points of concern.”
Some of the points of concern identified by AbbVie recurred in feedback from other organizations. One common thread running through the responses was a concern about the requirement for the principal investigator to maintain the product specification file and verify that the experimental drug meets the specifications and is suitable for release.
Medicines New Zealand and two of its members, AbbVie and Roche, raised concerns with this split of responsibilities. AbbVie’s feedback was representative of the concerns expressed by respondents.
“The role of the principal investigator in this regard needs to be further explained or clarified as the manufacturer and clinical trial sponsor is responsible for the checking of specifications and release of the product. We do not believe that the Investigator has the best background with regard to the technical release specifications of the product,” AbbVie wrote in its feedback.
Medsafe changed the guideline in response to the feedback. The guideline now places responsibility for holding and maintaining the specification file on the manufacturer. The manufacturer will provide the sponsor with a certificate of analysis for each batch of the investigational product. Using these materials, the sponsor will confirm the investigational medicine meets the specifications set out in the investigator’s brochure before releasing it for administration to subjects in the study.
The change to the handling of specification files is among the more substantive revisions Medsafe made in response to the feedback. Other changes triggered by feedback addressed questions about how to report adverse events and clarified that sponsors must halt testing in New Zealand when the overseas arms of a trial are stopped for safety reasons.
Medsafe declined to make changes in response to other pieces of feedback, though. A request for an abbreviated approval process for clinical trials targeting unmet medical needs was dismissed on the grounds that Medsafe already reviews “almost all” applications within two to three weeks.
The agency also dismissed fears, expressed by Boehringer, that the requirement for protocol changes to receive Medsafe approval may affect study timelines. In its response, Medsafe stated, “Approval has always been required for changes to trial protocol.” As there is no change to the situation, Medsafe does not expect timelines to be affected.
Medsafe published the final, post-feedback version of its guideline on study regulatory approvals and good clinical practices alongside its new clinical trial site notification form. The person in charge of a study site needs to complete the form to keep patients at the center overnight for monitoring after they receive a study drug.
, Consultation Outcome
, Notification Form
China Posts Guidelines to Standardize Clinical Trials of Brain Disorder Drugs
China’s National Medical Products Administration (NMPA) has posted two technical guidelines about the clinical development of drugs to treat brain disorders. The texts set out considerations specific to the clinical development of antipsychotics and treatments for bipolar disorder.
In each guideline, NMPA outlines some basic areas in which clinical trials targeting the indications overlap with other studies, but largely refers readers to other texts for details of these common elements. That approach allows NMPA to focus on the specifics of antipsychotic and bipolar drug development, such as the nature of the conditions and their effects on the design of clinical trials.
For example, the antipsychotic guideline notes that schizophrenia is treated using a long-term plan that is broken up into different phases in which symptoms are reduced and remission maintained. In light of this plan, NMDA expects sponsors to first show their drugs relieve symptoms. This initial test corresponds to the acute treatment phase. If this study is successful, NMDA thinks sponsors should assess longer-term safety and efficacy to show the drug can be used in the maintenance phase.
NMDA is advising sponsors to track patients in the acute, short-term stage of clinical development for at least six weeks. The agency proposes two designs sponsors can use to gather long-term data. One design is event-driven, meaning it ends when, for example, a certain proportion of subjects have relapsed. The other design simply tracks patients for six months or more.
NMDA’s advice to developers of bipolar drugs follows a similar model. The use of clinical treatment guidelines to shape drug development continues in other sections of the documents, such as those covering the selection of patient populations. Other topics addressed by the texts include the selection of endpoints, the choice of comparator and assessments of combinations of medicines.
None of the recommendations are binding or mandatory. NMDA plans to update the documents as the progress of scientific research informs its views on guiding principles for drug development.
, Bipolar Guideline
TGA Creates Guide to Adverse Event Management System for Sponsors
Australia’s Therapeutic Goods Administration (TGA) has published a guide to help sponsors use its adverse event management system (AEMS). The guide walks sponsors through how to create accounts and use the AEMS reporting dashboard.
TGA used to collect reports of side effects through the adverse drug reaction system, but has now decommissioned that system in favor of AEMS. To help sponsors adapt to the new system, TGA has released a step-by-step guide to many of the common processes users will need to work through, such as the completion of adverse event reporting forms.
The agency released the guide alongside a separate document aimed at healthcare professionals.
China Outlines Plans to Blacklist Companies as Part of Social Credit System Rollout
China’s NMPA has outlined plans to blacklist medical device companies that submit false materials or otherwise make major violations of regulatory standards. The blacklist forms part of a planned credit management system covering medical device applicants.
The Chinese government is working to introduce systems for monitoring the reputations of citizens and organizations in multiple areas. In the context of medical device applications, the system may manifest in a public blacklist of companies that have seriously violated licensing requirements or filed false information.
NMPA wants to cooperate with other government departments on the system. By working with other agencies, NMPA may be able to better track the reputations of companies and expand its ability to punish wrongdoing.
The regulatory agency published details of the blacklist as part of a document about its approach to different types of medical device license. The document lays out how NMPA plans to shorten review and approval times.
has issued a warning about Boston Scientific's SQ-RX Model 1010 Pulse Generator
. The alert relates to potential battery malfunctions that could affect subcutaneous implantable cardioverter defibrillator systems. TGA Notice