Asia-Pacific Roundup: High volume of GMP clearance extension applications cause delays at TGA

Australia’s Therapeutic Goods Administration (TGA) has outlined how “extremely high volumes” of filings for good manufacturing practice (GMP) clearance extensions are affecting its operations and what the delays mean for sponsors.

TGA issues GMP clearance to sponsors of medicines and active pharmaceutical ingredients produced overseas that provide acceptable evidence of compliance with GMPs. Australia introduced the GMP verification mechanism to reduce the regulatory burdens on manufacturers while maintaining assurance that overseas facilities have appropriate production processes and quality control procedures.

The latest problems stem from an increase in the volume of applications for extensions, which has resulted in delays in processing times. TGA warned that it might be able to complete the processing of some extension applications after the existing clearances have expired.

If a clearance expires before an extension is granted, TGA asks sponsors not to contact its team unless it affects a regulatory submission to list, register or vary a product on the Australian Register of Therapeutic Goods. In that scenario, sponsors can contact TGA’s GMP clearance team.

TGA also asks sponsors to file extension applications at least one month before their GMP clearances expire.

The administration attributed the current difficulties to factors that caused the number of applications to increase throughout the pandemic, including travel restrictions delaying the return of international GMP inspections to pre-pandemic levels, longer processing times for GMP clearance assessments because of new processes introduced during the pandemic and delays to its inspections. Last year, TGA said volumes had increased by 36% since its 2018-19 financial year (RELATED: Asia-Pacific Roundup, Regulatory Focus, 25 October 2022).

Also impacting processing times, according to TGA, are extensions linked to medicine shortage notifications and COVID-19 vaccine and treatments, extension applications submitted less than one month before expiry, and increases in “reinstatement” requests as changes that have affected processing times.

Because reinstatement requests – necessary when sponsors allow their GMP clearances to expire for more than 30 days – “take considerably longer to process,” they place additional burdens on TGA’s GMP clearance team. TGA previously worked from 2015 to 2019 to clear a backlog of 5,600 applications that built up as volumes rose and caused processing times to extend to nine weeks at one point.

TGA Notice

Malaysia’s MDA updates guidance on medical face masks and respirators in response to WHO

Malaysia’s Medical Device Authority (MDA) has published the third version of its guidance on medical face masks and respirators, which includes changes based on the recommendations of the World Health Organization (WHO).

MDA published the first of its guidance documents on face masks and respirators in January 2021 to clarify the rules on when the products are classed as medical devices and outline its minimum performance and labeling requirements for items that meet the definition. The authority released a second edition of the text later in 2021.

Changes to the main body of the third version of the guidance impact only formatting or wording; however, MDA has altered the content of an annex that sets out WHO’s recommendations on what type of mask should be used in various healthcare situations. WHO updated its COVID-19 guidelines on masks early this year.

The revised MDA guidance still states who should wear which type of mask in which settings and while performing different activities; however, the details have been changed. For example, the table now addresses what mask is appropriate for inpatients in rooms with single or multiple beds where a physical distance of at least one meter cannot be maintained. The minimum requirements for medical devices are unchanged.

MDA Guidance

TGA issues fines amid clampdown on the unlawful importation of prescription medicines

TGA has issued fines to three healthcare providers for allegedly illegally importing unregistered prescription-only medicines into Australia. The administration framed the actions to target the unlawful importation of prescription medicines.

In each unrelated case, a healthcare provider purchased medicines from overseas websites for importation into Australia to treat their patients. An osteopath allegedly imported unregistered injectable procaine. A general practitioner is accused of importing unregistered botulinum toxin type A. A dentist allegedly imported an unregistered antibiotic.

Officials seized the medicines at the Australian border and will not release them. The health providers lacked prior approval or exemption from the TGA to import the medicines and, between them, have received five infringement notices totaling AU$13,320 ($8,860).

The seizures and fines result from its work to ensure the quality, safety and efficacy of medicines used in Australia, TGA said. As unregistered prescription drugs, the imported products were not evaluated by the TGA and may be unsafe. Only the supplier approved by TGA can import medicines for commercial use, although lawful access pathways for unregistered goods exist.

TGA Notice

Singapore’s HSA hits target screening turnaround times for all drug application types

Singapore’s Health Sciences Authority (HSA) met its target screening turnaround times for all types of drug applications in the six months up to March 31.

HSA targets a screening turnaround time of 50 working days from receipt of the application dossier to the date of acceptance or nonacceptance/withdrawal, excluding the time taken for the applicant to respond. The update covers HSA’s turnaround times for new drug applications, generic drug applications, and major variations from the start of October 2022 to the end of March 2023.

Over that period, the mean response time for generic drugs was the longest, at 37.4 working days, followed by new drugs, at 30.6 working days, and major variations, at 16.3 working days. HSA received submissions for 57 new drugs, 129 generics and 59 major variations over the analyzed period.

HSA Notice

China’s rate of medical device approvals normalizes in April after bumper March batch

The number of medical device approvals by China’s National Medical Products Administration (NMPA) fell 38% sequentially in April, normalizing after a very active March.

NMPA approved 290 medical devices in March, compared to 124 and 162 in January and February, respectively. The number of device approvals fell to 180 in April.

The decline was driven by a drop in NMPA approvals of domestic Class III medical device products, which fell from 227 in March to 125 in April. The rest of the difference between the two months was accounted for by a fall in approvals of imported Class III medical device products, from 33 in March to 21 in April.

NMPA Notice (Chinese)

Asia-Pacific Roundup: High volume of GMP clearance extension applications cause delays at TGA

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