Asia-Pacific Roundup: Singapore’s HSA details changes to eCTD implementation

Singapore’s Health Sciences Authority (HSA) has detailed changes it will make to its implementation of the electronic Common Technical Document (eCTD) in response to feedback it received during a consultation earlier this year.

HSA is still working with its vendor to address the more than 250 comments that it received from 25 companies during the consultation, but last week provided an interim update on five actions triggered by the feedback. The changes cover tweaks to the implementation of a policy that will enable HSA to switch to full e-submissions.

Under its original proposal, HSA would have required companies to generate a universally unique identifier (UUID) and construct an application folder name using a PRISM application number. However, the agency now says the process is “prone to error,” leading it to change its plans. The solution is for HSA to issue unique e-identifiers via the portal for use as the name of the application folder. Companies no longer need to generate UUID.

The consultation revealed a lack of clarity about the need for companies to use PRISM for application filing and the eCTD portal for transmitting the dossier, and about the requirements for baseline submissions. In response, HSA plans to update the specification document to clarify the order of submission in the PRISM and eCTD portals and include illustrations of business workflow for baseline and transfer submissions.

HSA’s third revision reflects feedback on the need for guidance on the procedures for submitting multiple dosage forms or presentations in one eCTD application. The feedback prompted HSA to work on options for companies to include multiple forms in a single application or to file separate applications. HSA plans to share guidance on the submission procedure and module organization for single applications in the updated eCTD package.

Finally, respondents commented on the lack of a regional stylesheet to facilitate viewing of envelope information and the failure to support electronic signatures on PDF documents. HSA plans to address the first point by including a regional stylesheet in the specification components package. In addition, the agency is working to “fine-tune the validation criteria” to allow electronic signatures in PDF documents.

HSA plans to publish an updated eCTD package in the second quarter of next year. The agency will give the industry a summary of the changes, plus updated specification and validation criteria documents, technical package and Q&A, and training and test submission schedules.

HSA Notice

TGA posts safety alert about compounded semaglutide-like products in Australia

Australia’s Therapeutic Goods Administration (TGA) has posted a safety alert about “an emerging trend for telehealth providers to offer compounded semaglutide-like products.”

There are constraints on the supply of semaglutide, the GLP-1 receptor agonist found in Novo Nordisk’s diabetes and weight loss drugs Ozempic and Wegovy. Compounding pharmacies have moved to meet the unfulfilled demand. However, the US Food and Drug Administration (FDA) voiced concerns about the practice earlier this year and Novo Nordisk has filed legal cases against compounding pharmacies.

In Australia, pharmacies can compound medicines in “exceptional clinical circumstances where all suitable alternative treatments using approved therapeutic goods, which are those included on the Australian Register of Therapeutic Goods, are unavailable, have failed or are deemed unsuitable for the patient,” according to TGA. Australian states and territories regulate drug compounding.

TGA sent a safety alert about the practice after learning that telehealth providers are offering compounded semaglutide-like products. The alert references the FDA’s earlier communications and offers advice to consumers.

“We strongly encourage consumers to discuss their individual clinical circumstances with their doctor or pharmacist, who are best placed to recommend an alternative medicine or treatment, or may be able to arrange supply of a replacement product from overseas through one of our access schemes,” TGA wrote. The agency also stated that it is illegal to advertise Ozempic or semaglutide to the public.

TGA Notice

Malaysia’s NPRA updates guidelines for registration of biosimilars

Malaysia’s National Pharmaceutical Regulatory Agency (NPRA) has updated its guidelines on the registration of biosimilars, adding new details intended to reduce clinical data requirements and minimize the use of animals in testing.

The second edition of the guidelines features changes to 10 sections. In the clinical section, NPRA has “clarified the roles and relevance of clinical efficacy studies for the benefit-risk assessment of biosimilars for the possibilities to reduce clinical data requirements (including factors that may influence the need for a comparative clinical efficacy and safety study).”

Other changes relate to nonclinical testing. NPRA has added new guidance on determining the need for in vivo animal studies and on the implementation of the 3R principles, an approach to replace, reduce and refine, and therefore ultimately minimize, the use of animals in biosimilar development.

NPRA also clarified the scope of the guidelines, explaining that some of the principles may apply to low molecular weight heparins and recombinant analogs of plasma-derived products, and added details related to other sections. The details clarified the conditions in which immunogenicity testing is deemed unnecessary and removed the interchangeability labeling requirement for package inserts.

NPRA Guidelines

TGA adds Bulgaria to MRA pathway, creates GMP clearance sponsor dashboard

TGA has begun assessing good manufacturing practice (GMP) clearances for sites in Bulgaria via its mutual recognition agreement (MRA) pathway.

The pathway allows Australian sponsors to benefit from shorter processing times, reduced fees and lower evidence requirements. TGA has expanded the list of countries covered by the MRA throughout the year, first by including Croatia, Estonia, Romania, Slovenia and Lithuania. Adding Bulgaria, one of Romania’s neighbors, continues the expansion in Eastern Europe.

TGA disclosed the news about Bulgaria alongside other updates related to its GMP clearance pathway. The agency has created a GMP clearance sponsor information dashboard to provide monthly updates on the processing timeframes for each application stream, current work on hand in the GMP clearance section, current priorities, and key messages and updates.

Officials have updated the GMP clearance guidance too. As part of the revisions, TGA has split off the steps for submitting information via the TGA Business Services portal to create a standalone document. The agency also shared details of what will happen to GMP clearances that expire next year, setting out different next steps depending on the age of the current evidence.

TGA Notice, More

Malaysia updates guidance on harmonized classification of devices, borderline products

Malaysia’s Medical Device Authority (MDA) has released the second editions of guidance documents on the harmonized classification of medical devices and borderline products in the Association of Southeast Asian Nations (ASEAN) region.

The two documents provide background information on the ASEAN Medical Device Directive and its influence over the classification of medical devices in Malaysia, but the key content in each text is a list. The lists feature descriptions and classifications of various products, which are either assigned to a risk category or borderline device grouping based on their characteristics.

MDA is updating the documents annually to reflect the latest decisions of the ASEAN Medical Device Committee. The borderline product guidance features 20 technologies that were missing from the first edition of the guidance.

Updated Guidance, More

Other News:

Singapore’s HSA has introduced a digital portal for submitting and managing dealer’s notices related to cell, tissue and gene therapy products. HSA Notice

Asia-Pacific Roundup: Singapore’s HSA details changes to eCTD implementation

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