Asia-Pacific Roundup: Japan changes electronic study data submission requirements

Japan’s Pharmaceutical and Medical Devices Agency (PMDA) has removed the requirement for companies to submit forms that describe the contents of electronic study data filings before submitting the data in a new drug application (NDA).

Under the old system, PMDA provided two forms for applicants to explain their electronic study data before filing NDAs that also contained the data. The forms covered basic information about the candidate product being submitted for approval, an overview of the clinical data package and details of the studies and clinical pharmacology.

PMDA continues to provide the forms and require sponsors to complete them to inform consultations related to the submission of electronic study data for NDAs. However, the agency has stopped requiring companies to submit the forms before filing NDAs that contain electronic study data.

Requiring the submission of the explanations was intended to help reviewers check the status of the electronic data submission. The forms provided applicants with the opportunity to explain any violations of the validation rule. However, PMDA has now decided it can eliminate that step in the submission process without disrupting the review of NDAs.

The update to the requirements was accompanied by the release of a revised frequently asked questions (FAQ) document. PMDA has deleted multiple questions related to the submission of the electronic study data explanations, removed other references to the forms and updated a table that discussed what applicants can expect to happen at pre-NDA meetings.

Compared to an earlier version, which PMDA released in June 2022, the current document features a new answer to a question about the timing and format of electronic data submissions. The agency is now advising applicants to use the gateway system or “a recording medium” to submit electronic study data “during the period from the date of submission of the consultation application to the date which the consultation materials are scheduled to be submitted.”

If data are not submitted alongside the consultation materials, applicants should contact PMDA to share the scheduled submission date in advance. PMDA also updated its advice on how to provide the data, recommending that applicants submit “a single zip file that maintains the folder structure.” If the zip file is too large for the gateway system or recording medium, applicants can submit multiple zip files. Submissions on physical media should use a single device, such as a multilayer Blu-ray disc.

PMDA Update, Revised FAQ

TGA seeks feedback on drug scheduling decisions, rejection of therapeutic use request

Australia’s Therapeutic Goods Administration (TGA) has released interim drug scheduling decisions for public consultation. The regulator is proposing to allow over-the-counter sales of a laxative and reject a request to schedule a psychedelic neurotoxin for therapeutic use.

TGA’s consultation covers interim decisions that its advisory committees on the scheduling of medicines and chemicals reached at meetings in June 2023. The administration is now seeking feedback on the decisions before finalizing the rulings ahead of anticipated implementation dates in 2024.

One of the decisions covers ibotenic acid, a psychedelic neurotoxin that is not currently listed in the Poisons Standard. The applicant proposed creating entries for the molecule in prescription only schedule 4, to support therapeutic use, and dangerous drug schedule 7, for all other uses. However, the interim decision assigns the molecule to schedule 9, which is reserved for prohibited substances.

The plan to limit access to ibotenic acid to research use is underpinned by concerns about “the high propensity for abuse and misuse, and risk of dependency of the substance.” The tendency for the substance to be misused “stems from the hallucinogenic and euphoric effects following ingestion,” the decision states. Public submissions about the molecule identified a high risk of accidental poisoning. The ruling is scheduled to take effect on 1 February 2024.

The committees also rejected a call to reschedule entries for amygdalin and hydrocyanic acid when the substances are in preparations containing Wild Cherry Bark that are listed in the Australian Register of Therapeutic Goods. The rejection reflects a perceived lack of new information that addresses toxicity risks associated with the substances.

TGA is also seeking feedback on decisions regarding the laxative bisacodyl, which is not currently scheduled, and the antihistamine olopatadine. The interim decisions support the sale of the medicines in pharmacies, provided certain conditions are met.

The administration is accepting feedback until 2 November 2023.

TGA Notice, Interim Decisions

NMPA holds training on internal review of vaccine regulatory quality management system

China’s National Medical Products Administration (NMPA) has held a training session on the internal review of the vaccine regulatory quality management system in Beijing. The session was part of an attempt to “cultivate more internal review professionals.”

NMPA said it views internal review as an important way to measure the effectiveness of the quality management system and promote its continuous improvement. Since 2020, the agency has held annual internal reviews to “detect problems, identify and control risks, and carry out inspections and rectifications.” The focus on vaccine regulation follows quality scandals.

The latest training session was intended to “cultivate backup internal reviewers for the vaccine regulatory system, accelerate the overall development of the drug regulatory quality management system, strengthen the awareness of quality, promote the integration of quality management into daily work, and improve the standardization of drug regulation,” NMPA said.

NMPA invited experts in quality management systems to the sessions to discuss the development of the ISO 9000 family of standards. More than 60 officials from NMPA and affiliated institutions attended the event.

NMPA Notice

Medsafe schedules day to discuss premarket submission, drug evaluation in New Zealand

New Zealand’s Medicines and Medical Devices Safety Authority (Medsafe) has scheduled an event to talk to the pharmaceutical industry about the premarket submission and evaluation of medicines.

On 9 November, Medsafe Industry Day will provide applicants, sponsors and consultants who submit and manage new and changed medicine applications with a chance to hear an update about the authority’s current work and receive guidance on technical topics. The meeting is not aimed at individuals who primarily work in postmarket quality or pharmacovigilance or good manufacturing practice production.

The meeting will take place in Wellington, New Zealand, and individuals planning to attend in person are required to register by 20 October. A video link is available for those who are unable to attend in person.

Medsafe Notice

DRAP orders increased surveillance after falsified contrast injection found in Pakistan

The Drug Regulatory Authority of Pakistan (DRAP) has told its regulatory field force to increase oversight of the supply chain after its staff discovered a suspected falsified lot of a radio-opaque contrast injection.

DRAP issued the rapid alert in response to the identification of a lot of Lipiodol Ultra Fluide that was set to be supplied to tertiary hospitals. The product is not registered in Pakistan and was not imported using a special permission pathway. DRAP warned that falsified or counterfeit Lipiodol can pose serious health risks, adding that the safety, sterility and quality of the product is unknown.

In the alert, DRAP tasked its regulatory field force with increasing surveillance throughout the supply chain, including at healthcare facilities, and confiscating any Lipiodol. The authority is also asking healthcare professionals to check their stock.

DRAP Notice

Asia-Pacific Roundup: Japan changes electronic study data submission requirements

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