Asia-Pacific Roundup: Singapore’s HSA shares eCTD specification package ahead of March launch

Singapore’s Health Sciences Authority (HSA) has published version 1.0 of its electronic common technical document (eCTD) specification package as it prepares to launch its eCTD portal, tentatively in March 2025.

The regulator also plans to arrange online training sessions for industry on the submission of eCTD packages via the portal in February. Then, when the portal goes live in March, stakeholders will be able to file test submissions during the first six months of operation.

“The contents of test submissions will not be reviewed and will be deleted from the system once testing is complete,” HSA said. “Thereafter, only actual submissions for product applications will be accepted.”

In preparation for the launch, HSA held a consultation on version 0.9 of its eCTD specification package in 2023. The version released for industry to use in eCTD tests last week contains eCTD specification and validation criteria, technical files and sample submissions. HSA made changes to version 0.9 in response to feedback.

HSA divided the revisions into three categories: changes to technical requirements, changes to validation criteria and additional changes to the specification document. The technical changes include the removal of a drug master file submission form that is no longer a documentary requirement and the provision of a regional stylesheet and optional HTML file.

One of the additional changes to the specification document allows companies that want to submit a baseline for currently registered products in a non-eCTD format to send a cover letter without including module 3 chemistry, manufacturing and controls data. Another of the changes will enable companies to choose between submitting single or separate applications for multiple strengths and dosage forms.

“Applicants should carefully weigh the pros and cons of combining or separating the strengths based on the product life cycle management of the product strengths,” HSA said.

HSA Notice

TGA reports updates on shortages of Lilly and Novo diabetes drugs in Australia

The Therapeutic Goods Administration (TGA) has provided updates on the Australian supply status of multiple diabetes drugs sold by Eli Lilly and Novo Nordisk.

TGA shared the information in three notices published last week. The first notice said Novo has told TGA that “it will gradually discontinue some of its earlier generation insulin products over the next two years.” In some cases, Novo is discontinuing one form of a product, such as a prefilled pen, but continuing to sell the drug in another format. In other cases, the company is completely stopping selling a product.

The run of discontinuations is scheduled to start in October, when TGA expects Novo to stop selling its Mixtard 30 Penfill insulin product, and end with the discontinuation of four products in December 2026.

TGA has made a Serious Scarcity Substitution Instrument to allow pharmacists to substitute Ryzodeg 70/30 Penfill cartridges for Ryzodeg 70/30 FlexTouch prefilled pens when Novo drops selling the latter product in February 2025. The FlexTouch pens have been in short supply since June 2023.

The Australian regulator published a separate notice about Lilly’s GLP-1 drug Mounjaro. Lilly has begun selling the diabetes and weight-loss drug as a prefilled pen in Australia. The drug was already available in vials but Lilly has told TGA supply of that format will remain limited into 2025. TGA is unsure how the launch of prefilled pens will affect the overall availability of Mounjaro.

Ryzodeg, Mounjaro, Novo

China NMPA outlines steps to accelerate development of innovative medicines

The China National Medical Products Administration (NMPA) has outlined actions to facilitate research and registration of homegrown innovative drugs and accelerate the introduction of novel foreign medicines to the domestic market.

NMPA said it approved 31 innovative drugs over the first eight months of 2024, an increase of almost 20% over the same period of last year. The number of newly cleared innovative medical devices, 46, was up more than 12%. Li Li, the director of NMPA, discussed the actions the regulator is taking to support the trends at a press conference.

“To advance opening-up in the pharmaceutical industry, we will also strengthen implementation of common international regulatory rules, support rollouts of international multi-center clinical trials and promote simultaneous research and review of global drugs in China,” Li said.

Regions including Beijing and Shanghai are running trial programs to halve review periods for innovative medications from 60 working days to 30 working days, Li said. Other actions discussed by the NMPA director include efforts to get international drugmakers to transfer manufacturing capacity of “novel and high-end medical products” to China.

NMPA Notice

Japan approves Lilly’s Kisunla for the treatment of early symptomatic Alzheimer's

Japan’s Ministry of Health, Labour and Welfare has approved Eli Lilly’s Kisunla for use in adults with early symptomatic Alzheimer's disease.

The authorization makes Japan the second major market to approve Kisunla. The approval covers the use of the amyloid beta-directed antibody in people who have mild cognitive impairment or are in the mild dementia stage of Alzheimer’s, with confirmed amyloid pathology. Patients will have the option to stop taking Kisunla once amyloid plaques have resolved.

Japan’s Central Social Insurance Medical Council is applying a special price-setting review process to the drug, like it did for Eisai’s rival product Leqembi. The scheme is designed to control the costs of potential blockbuster medicines. Some officials are reportedly concerned about the impact of Alzheimer’s drugs on public finances in Japan, a country where 24% of the population is 65 years or older.

Kisunla is still expected to join Japan’s National Health Insurance price list within 60-90 days, the standard gap between approval and inclusion on the list.

Press Release

Other news:

The Philippine Food and Drug Administration (FDA) has brought its Online Disclosure Reporting System (ODRS) back online. FDA published a notice about the system being offline for maintenance in July. The new notice states ODRS is “now fully operational and accessible.” Stakeholders can “resume encoding and submission of reports through the ODRS,” FDA said. FDA Notice

Malaysia’s Medical Device Authority (MDA) has told companies the Ministry of Health will stop accepting payments through bank drafts on 1 October. The change is in line with the Ministry’s plans to move to a fully online payment system. Starting 1 October, medtech companies will need to use the Medcast 2.0+ system and BayarNow system to send payments. MDA Notice

The Drug Regulatory Authority of Pakistan (DRAP) has published a recall notice about a batch of Treat Pharmaceutical Industry’s paracetamol. A drug testing lab ruled the batch is substandard. The infused product contains visible particles, which DRAP said are “a serious indicator of substandard quality” and can lead to significant health risks such as high fever, arterial blockages and infarction. DRAP Notice

TGA is seeking feedback on proposed changes to the Poisons Standard. The latest set of proposals, which committees will discuss at a meeting in November, include the rescheduling of astodrimer sodium when used as a vaginal gel for the treatment, relief and prevention of bacterial vaginosis. TGA is accepting feedback on the proposals until 22 October. TGA Consultation

Asia-Pacific Roundup: Singapore’s HSA shares eCTD specification package ahead of March launch

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