Asia-Pacific Roundup: TGA new drug approval times hold steady despite pandemic pressures

RoundupsRoundups | 27 April 2021 |  By 

Australian approval times for new drugs and other filings held steady in the second half of 2020 despite the pressures COVID-19 put on regulatory officials, according to a TGA report.
The median approval time for new chemical entities, new biological entities and biosimilars over the back half of last year was 196 days, compared to 198 days in 2019 and a legislated timeframe of 255 days. TGA median approval times for major variations and new generic medicines fell 4% and 12%, respectively.
There were some increases in review times, the median turnaround for indication extensions rose by 10%, but the timelines for many regulatory processes were flat to down compared to 2019. Even after the 10% increase over 2019, the median review time for indication extensions was still around 60 days under the legislated timeframe.
Elsewhere, TGA reported declines in the median approval times for orphan drug registrations involving new entities and indication extensions. TGA granted more orphan drug designations over the second half of 2020 than in the comparable period of 2019.
TGA achieved the turnaround times while dealing with work related to the pandemic. The number of medical devices added to the Australian Register of Therapeutic Goods over the second half of 2020 was up 54% over the prior reporting period.
TGA Report
TGA plans update to AstraZeneca COVID-19 vaccine label amid more blood clot cases
Australia’s Therapeutic Goods Administration (TGA) has outlined a need for further updates to the product information for AstraZeneca’s COVID-19 vaccine Vaxzevria. The update follows the discovery of three new cases of suspected thrombosis with thrombocytopenia syndrome (TTS).
TGA worked with AstraZeneca to update the product information for the vaccine early this month as it and its peers in Europe gathered evidence of a possible link to cases of blood clots with low levels of platelets. Now, with the number of suspected cases of TTS in Australia rising to six, TGA is set to make further changes to the product label.
The agency detailed the need for another update after its Vaccine Safety Investigation Group (VSIG) concluded that three new cases of TTS were likely linked to AstraZeneca’s prophylactic. VSIG reached the conclusion after assessing the cases using a World Health Organization approach to causality.
TGA said the cases were consistent with the current working case definition for TTS and there was a lack of known alternative risk factors for the events. Two of the cases were milder than those seen in other patients and were recognized early. In one patient, the platelet count was only “depressed to a limited extent,” while another individual developed symptoms 26 days after vaccination.
One patient had a clot in one of the sinuses that allows blood to drain from the brain. The two other patients had blood clots in their legs, a more common site for vascular blockages. All three patients were clinically stable as of TGA’s update on 23 April. The patients responded to treatment and were recovering at the time of the update.
The new cases bring the total number of reports of TTS after the administration of Vaxzevria up to six. Five of the cases occurred in people aged under 50 years old. Those five people received the vaccine before Australia decided to make the Pfizer-BioNTech vaccine the preferred option for people aged 50 years and under.
After reviewing the new cases, the Australian Technical Advisory Group on Immunisation reiterated its position that Pfizer’s Comirnaty is preferred to AstraZeneca’s Vaxzevria in people aged 50 years and under. Vaxzevria can be used in the population if Comirnaty is unavailable, the benefits are likely to outweigh the risks and informed consent is obtained.
TGA Notice
Philippine FDA seeks feedback on collaborative review of WHO-prequalified drugs
The Philippine Food and Drug Administration (FDA) is seeking feedback on guidelines about the collaborative procedure for the accelerated registration of prequalified drug products and vaccines.
Through the collaborative procedure, the World Health Organization (WHO) seeks to facilitate the accelerated national registration of products it has prequalified. FDA framed its participation in the initiative in the context of “current resource constraints affecting drug regulation” that necessitate collaboration and convergence with WHO and other “stringent regulatory authorities.”
In light of those pressures, FDA is proposing to adopt the WHO collaborative registration procedure as a pathway to market in the Philippines. FDA will retain “its prerogative to assess applications and apply judgments that consider benefits and risks as it applies to the Philippine context.”
Applicants must ensure that the manufacturer or prequalification holder has submitted the required WHO paperwork before filing a registration application with FDA. The filing with FDA must include an application form, a dossier compliant with existing requirements and country-specific materials, such as foreign good manufacturing practice clearance issued by the Philippine regulator.
FDA will take up to 15 calendar days to assess the completeness of submissions. Once given access to shared WHO documents, FDA will have up to 90 calendar days to evaluate the application and make a decision.
The agency is accepting feedback on the draft until 4 May.
FDA Notice
GSK pushes New Zealand’s Medsafe to tweak ibuprofen recommendation
GlaxoSmithKline has asked a New Zealand Medicines and Medical Devices Safety Authority (Medsafe) committee to reconsider its recommendation on the reclassification of 400 mg ibuprofen as a pharmacy medicine.
GSK warned the proposed wording of the ibuprofen schedule entry will “inadvertently capture” two applications that are currently undergoing additional evaluation by Medsafe. The applications are for modified-release formulations of the anti-inflammatory painkiller, whereas the reclassification covers an immediate-release product.
“Given such modified release formats have yet to be approved by Medsafe and have no market experience in New Zealand, it is suggested that should the [committee] recommend classification of 400 mg ibuprofen as a Pharmacy Medicine that the proposed wording of the schedule entry be amended to specify immediate release 400 mg ibuprofen,” GSK wrote.
GSK was the only organization to comment on the reclassification. Medsafe received more feedback on a proposal to reclassify 300 mg ibuprofen in powder form from a prescription to pharmacy-only medicine.
Two pharmacy bodies and Reckitt Benckiser raised concerns about the reclassification of the powder form of the painkiller. Reckitt Benckiser called the reclassification “atypical and inappropriate” on the grounds that the product is a new ibuprofen format with no in-market experience.
Medsafe Notice, Agenda Feedback
Philippine FDA updates guidelines on emergency registration of COVID-19 drugs
The Philippine FDA has updated its guidelines on the registration of drug products for emergency use against COVID-19. FDA used the update to provide additional information on the generic labeling exemption (GLE) and otherwise tweak the document.
In the latest version of the guidelines, which have undergone multiple rounds of revision since being published one year ago, FDA has changed the wording of its list of documentary requirements and added details of the fee for GLE filings. Seeking GLE, which “may be granted for products exceeding 12,000 units,” costs PHP 500 ($10)
FDA updated the guidelines after the Philippines replaced advice from a microbiology and infectious disease society, PSMID, with the Philippine COVID-19 Living Recommendations. The new text, which is the work of PSMID and other organizations, will consolidate recommendations from various bodies and provide a continually updated review of the scientific evidence.  
FDA Notice, More


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