Asia-Pacific Roundup: TGA/Access set out evidence requirements for COVID vaccine

RoundupsRoundups | 08 December 2020 |  By 

Australia's Therapeutic Goods Administration (TGA) and its international collaborators in the Access Consortium have posted their approach to the regulatory evidence requirements for COVID-19 vaccine approvals. Access is a consortium of regulators from Australia, Canada, Singapore, Switzerland and the UK.
Clinical trials should ideally show vaccines cut the transmission of SARS-CoV-2, including from asymptomatic people, as well as reducing incidence of COVID-19 in vaccinated individuals, according to the Access statement. It is still unclear whether the leading vaccines prevent transmission or just reduce symptomatic COVID-19. Pfizer/BioNTech investigators are looking at ways to assess the effect of its vaccine on transmission. Testing of asymptomatic people by AstraZeneca/University of Oxford offered some encouragement that its vaccine may reduce transmission.
In terms of safety, the Access statement is in line with the position of other regulators, notably in its recommendation of at least two months follow up for all individuals. The consortium wants to see 6 months of follow up for some subjects “to assess the potential risks of late-onset adverse events and vaccine-associated enhanced respiratory disease.” Robust safety and effectiveness monitoring once a vaccine comes to market will ensure the benefits continue to outweigh the risks.
Access issued the statement shortly after its newest member, the UK Medicines and Healthcare products Regulatory Agency (MHRA), cleared the Pfizer/BioNTech vaccine for temporary use. The speed of the MHRA decision drew some criticism from officials in the US and European Union, who favor a slower approach intended to increase public confidence in vaccines.
In a statement, TGA, which is assessing preliminary data on three COVID-19 vaccines but is yet to authorize any, noted the limited nature of the UK action, which covers a set number of batches, and framed the speed of MHRA’s action as a result of the number of COVID-19 cases in the country.
Access Notice, TGA Statement, More
TGA updates guidelines on medical device priority applicant determination
TGA has updated its guidelines on the priority applicant determination criteria and process. The guideline, an update of a 2018 text, is designed to help developers of medical devices and diagnostics to access TGA’s priority pathway.
The guideline applies to the prioritization of requests for TGA conformity assessment certificates, a step companies with overseas clearances can skip, and inclusion of devices in the Australian Register of Therapeutic Goods.
Changes to the version of the guideline published in 2018 include the reworking of a flowchart of the designation process. The new flowchart states applicants should begin by arranging a pre-submission meeting, before submitting their application and paying the invoice. TGA will then assess the application, aiming to complete the process in 20 working days, and issue a decision via a delegate. The 2018 flowchart states the pre-submission meeting is optional and lacks a line about the invoice.  
The changes to the flowchart are intended to make the guideline “more accurate, detailed and consistent with current legislation and practices,” TGA said. The agency made other changes to the text with the same goal in mind.
TGA posted the updated guidelines alongside an application form for priority applicant determination. The form covers conformity assessment and medical device determinations, with a tick box used to inform TGA of the focus of the application.
TGA Guidelines, Application Form
India extends validity of import licenses in response to COVID, industry requests
The Indian government has extended the validity of Form-10 import licenses to ensure the supply of medicines amid disruption wrought by COVID-19.
In a legislative order, the Indian government said pharmaceutical companies and associations have asked it to extend valid import licenses by six months. The government responded by asking holders of import licenses to apply for a new certificate before their existing authorizations expire. Licences of companies that comply with the request will remain valid until their application is reviewed.
The provision nullifies the risk that delays to the processing of import licenses, which last for three years, will prevent companies from continuing to import medicines into India. The government said the regulatory flexibility will apply for the next six months. 
Government Notification
Philippine FDA publishes interim guidelines on inspecting radiation facilities
The Philippine Food and Drug Administration (FDA) has published interim guidelines on carrying out licensing inspections of radiation facilities. FDA adopted the interim practices in response to the need to perform authorizations during the pandemic.
With Philippine authorities downgrading the quarantine level in Manila, FDA wants to resume the authorization process without putting its staff in danger. The interim test is intended to support that objective by providing guidelines for pre-licensing inspections of facilities that work with X-ray and magnetic resonance imaging equipment.
The guidelines state FDA will initially only resume pre-licensing inspections of sites that use medical linear accelerators. Inspectors will carry out assessments remotely, when possible in part through a virtual tour of the facility. The guideline provides an overview of the process.
FDA will authorize other types of facilities without an inspection. Rather, FDA will use a risk-based approach that makes use of self-assessment submissions. FDA will verify facilities in post-licensing inspections once quarantine measures are lifted.  
FDA Guidelines
China’s CDE posts guidance on single-arm clinical trials of oncology drugs
China’s Center for Drug Evaluation (CDE) has published guidance on single-arm clinical trials of cancer medicines. The guidance describes how CDE will interact with developers that want to assess their drug candidates in single-arm studies.
CDE framed the guidance in the context of the move from targeting cancers based on the organ they affect to the molecular delineation of indications. The process has created some small, previously unrecognized groups of cancer patients linked by shared biomarkers. Trying to move quickly to get drugs to those small patient populations, companies are increasingly running single-arm trials.
The CDE guidance states randomized clinical trials remain the gold standard. To persuade CDE to allow an alternative approach, drug developers will need to fully evaluate the feasibility of just doing single-arm studies. CDE named the current treatment options and reliability of historical data among the topics it wants drug developers to consider.  
CDE Notice (Chinese)
Other News:
The Malaysian Medical Device Authority (MDA) is seeking feedback on the quality of its service. MDA is running the survey to gauge perceptions of its guidelines for medical device registration filings, the wait for issuing certificates and other topics. The survey is open for comment until the end of the month. MDA Notice


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