Asia-Pacific Roundup: Australia’s TGA tracks 10% drop in GMP clearance backlog since mid-October peak

Australia’s Therapeutic Goods Administration (TGA) has cut its backlog of good manufacturing practice (GMP) clearance compliance verification (CV) applications by around 10% since the logjam peaked in mid-October.

TGA uses its clearance pathways to verify that overseas manufacturing sites that supply medicines to Australia meet GMP requirements. The agency reviews applications via the CV pathway through desktop assessments. TGA assesses documents from overseas regulatory authorities and other materials to show if a production plant complies with the principles of GMP.

Last week, TGA reported that its backlog of GMP CV clearance applications had fallen from the peak of 2,547 that it hit in mid-October. Since then, the size of the backlog has fallen by 237 applications, around 10%. TGA attributed the decline to a 23% reduction in the queue of applications for non-sterile active pharmaceutical ingredients (APIs), which has 255 fewer entries than at its peak. The backlog of sterile finished product applications is also down 25 applications, around 10% of its peak.

TGA expects overall application numbers to continue to fall in the coming months. The forecast is based on the expectation that the training of new GMP evaluators will advance and increase TGA’s capacity. As that happens, TGA will shift its focus to the queue of non-sterile finished products to start chipping away at that part of the backlog.

The latest data show TGA is assessing 90% of sterile finished product applications in 395 working days. The figure for sterile API submissions is 420 working days. Non-sterile applications are taking longer to process, with TGA handling 90% of finished product and API submissions in 441 and 457 working days, respectively.

TGA has grappled with the volume of GMP clearance applications for years. The number of applications rose from 2,500 in the 2010-11 period to 5,600 in TGA’s 2015-16 financial year. Processing times climbed to nine weeks, around 60 days. TGA extended its deadline, adopted stock clock mechanisms and reduced its backlog. However, a jump in submissions through the pandemic years, coupled to the lack of primary evidence available in that period of restricted travel, created fresh problems.

TGA Notice

TGA posts alert about counterfeit Ozempic pens after border seizures

TGA has posted another alert about counterfeit Ozempic pens after fake copies of Novo Nordisk’s GLP-1 drug were again seized by Australian border officials.

Counterfeit Ozempic became a global problem as demand for the product, which contains the diabetes and weight-loss treatment semaglutide, exceeded supply. Novo has told TGA the supply of Ozempic will remain limited in Australia this year. With demand exceeding supply, counterfeiters have identified an opportunity to sell fake copies of Ozempic and other GLP-1 drugs online.

TGA published an alert in September after receiving one report of a life-threatening adverse event in Australia. The person had used a counterfeit pen labelled as Ozempic that contained insulin. TGA issued another alert last week after further examples of counterfeit Ozempic-labelled products were stopped at the Australian border.

The products look like genuine Ozempic injections, TGA said, but Novo has confirmed the batch number listed on the packaging is fake. TGA also “identified typographic inconsistencies in packaging compared to legitimate Ozempic products, including differences in spacing and bolding of the text.”

The agency is yet to comment on what the pens contain. The prefilled pens that triggered the September alert contained the undeclared substance insulin glulisine. TGA said the latest seizure is a new issue and is distinct from the September alert. The recently seized products have not been assessed by TGA for quality, safety or efficacy, as is required under Australian legislation.

TGA is continuing to check the batch numbers of any products that may be subject to counterfeiting and to work with the Australian Border Force to help stop future shipments of counterfeit and substandard Ozempic.

TGA Notice

India’s CDSCO proposes new risk classifications for cardiovascular and neurological devices

India’s Central Drugs Standard Control Organization (CDSCO) has proposed updates to its risk-based classifications of cardiovascular and neurological medical devices.

CDSCO created risk-based classifications in 2017 and provided new information specific to cardiovascular and neurological devices in 2021. The 2021 lists covered risk categories for 36 cardiovascular devices and 110 neurological technologies.

The new lists cover 351 types of cardiovascular devices and 202 groups of neurological products. CDSCO is proposing to assign more than 200 of the devices to Class D, the highest risk category in India. The list of Class D devices includes aortic bi-leaflet mechanical heart valve prostheses and spinal cord nerve implantable analgesic electrical stimulation systems.

CDSCO has provided the name, intended use and risk class for each entry. The intended use provides a brief summary of the product, explaining, for example, that an aortic bi-leaflet mechanical heart valve prosthesis is “an artificial substitute for a natural aortic heart valve intended to be implanted during open heart surgery typically to treat acquired or congenital valvular disease.”

CDSCO Notice

MDA sets date for Malaysia’s switch to online product classification applications

Malaysia’s Medical Device Authority (MDA) is planning to handle the product classification application process entirely through Google Forms starting 1 May.

MDA has created an online form that Malaysian companies, and the local authorized representatives of foreign companies, can use to determine whether a product is classified as a medical device or not. The form cannot be used to determine the risk and rules classification of a medical device.

The agency said the online process is intended to “enhance efficiency, streamline submissions, and improve the overall experience for applicants.” Using a Google Form to collect the information “will ensure a more organized and accessible process,” MDA said.

“Upon approval, the official product classification letter will be sent directly to the email address provided in the application form. Please note that hard copies will no longer be mailed out,” MDA said. The agency is encouraging applicants to familiarize themselves with the new process.

Starting 1 May, all newly issued product classification letters will be valid for up to two years from the release date of the letter. MDA said the change will “ensure alignment with the latest regulatory requirements and facilitate better industry compliance.”

MDA Notice, More

Malaysia’s NPRA moves consumer medication information filings to online portal

Malaysia’s National Pharmaceutical Regulatory Agency (NPRA) is asking companies to use its QUEST 3+ system to submit certain materials for evaluation by its pharmacovigilance team.

The request applies to consumer medication information leaflets (RiMUP). Pharmaceutical companies develop RiMUPs, following regulatory guidelines, to convey important information on prescription and non-prescription medicines registered for use in Malaysia. Companies submit the leaflets for evaluation by pharmacovigilance officials.

Previously, companies needed to manually submit RiMUPs for review. Starting this month, NPRA wants companies to submit materials via its QUEST 3+ online portal. The agency is asking applicants to send an email to its RiMUP team after they submit the materials.

NPRA clarified that “there is no change to the existing procedure for all products registered after 1 January 2014, whereby the RiMUPs are evaluated by the Centre of Product and Cosmetic Evaluation.” The agency has updated its guidelines with specific details of the affected products.

NPRA Notice

Asia-Pacific Roundup: Australia’s TGA tracks 10% drop in GMP clearance backlog since mid-October peak

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