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Asia-Pacific Roundup: Philippine FDA posts COVID trial guidance

Posted 20 October 2020 | By Nick Paul Taylor 

Asia-Pacific Roundup: Philippine FDA posts COVID trial guidance

The Philippine Food and Drug Administration (FDA) aims to process clinical trial requests for COVID-19 therapeutics in 30 days and vaccines in 40 days, compared to 60 days under the standard workflow, according to new guidance.
 
Existing regulations on the conduct of clinical trials of investigational products and the licensing of sponsors and contract research organizations apply to the study of COVID-19 therapeutics and vaccines in the Philippines, the guidance explains. However, the situation is complicated by the need to move quickly and the involvement of the Inter-Agency Task Force for the Management of Emerging Infectious Disease Resolution and the Department of Science and Technology (DOST).  
 
The process for COVID-19 therapeutics is an accelerated version of the standard workflow. As in the normal workflow, FDA’s Center for Drug Regulation and Research will pre-evaluate an application, assign reviewers to fully assess the submission and then decide whether to authorize a trial based on their recommendations. The big difference is the regulatory review stage will take 14 days, compared to 45 days under the standard process. Both figures exclude time taken to clarify applications. With FDA also shaving one day off the time it takes to make its final decision, the agency is set to halve the timeline.
 
At 40 days, the timeline for processing applications to study COVID-19 vaccines is longer but FDA’s portion of the process is even more truncated. The extra time needed to approve vaccine clinical trials stems from a 14-day wait at the start of the process while DOST’s Vaccine Expert Panel reviews the submission.
 
The process moves unusually quickly once the 14-day DOST review is over and the submission is sent to FDA. When handling applications to study COVID-19 medicines, FDA assigns regulatory reviewers seven days after receiving an application. That period is truncated to two days under the workflow for COVID-19 vaccines, enabling FDA to establish a 40-day timeline for the complete process. 
 
ClinicalTrials.gov lists five COVID-19 clinical trials with sites in the Philippines, including Johnson & Johnson’s 60,000-subject Phase 3 study of the Ad26.COV2.S vaccine.
 
FDA Guidance
 
TGA introduces device postmarket review compliance dashboard
 
Australia’s Therapeutic Goods Agency (TGA) has created a dashboard for use by companies that want to respond to postmarket reviews of medical devices. The dashboard, which went live on Monday.
 
Notifications sent to sponsors from now on will include details of how to use the dashboard in the TGA Business Services system. TGA has created a user guide to explain how to login and use a dashboard that it expects to improve the postmarket review process.
 
“The new dashboard provides an efficient and secure way of responding to postmarket reviews and storing the information in a central location. This will also make it easier to access reviews (active and closed) and remove the need to resend information to different teams at the TGA as they will have access to this information in the dashboard,” the agency wrote.
 
The dashboard supports uploads of files as large as 15 GB, which exceeds the maximum attachment size of many email services, which meant sponsors had to send large files via USB drives or cloud services.
 
TGA Notice, User Guide
 
Pakistan’s DRAP shares guidance on CTD applications 
 
The Drug Regulatory Authority of Pakistan (DRAP) has introduced guidance on filing for registration of human medicines using an adapted Common Technical Document (CTD) format as part of its preparations for the phased switch to CTD in Pakistan.
 
Legislation adopted in 2018 set Pakistan up to transition to the use of the CTD-based Form 5F. DRAP has already released Form 5F and the M4 series of texts published by the International Conference on Harmonisation (ICH) provides advice on the CTD format. DRAP has identified the need for guidance that supports the submission of consistent applications in Pakistan though, leading to the publication of a document setting out its position.
 
The guidance provides a line-by-line breakdown of the Form 5F, explaining what information DRAP expects applicants to include in each section. For example, the guidance states applicants should provide a drug substance’s “structural formula, including relative and absolute stereochemistry, the molecular formula, and the relative molecular mass” in the general information section of the quality module.
 
That line is copied verbatim from ICH’s M4 guideline for the quality module but DRAP has diverged from the international documents in multiple other areas, both by omitting sections present in the harmonized texts and adding new lines. The result is a document designed to limit variability in the contents and quality of Form 5F submissions to DRAP.
 
DRAP Guidance
 
TGA changes Declaration of Conformity rules for some Class I medical devices
 
TGA has changed the process for adding Class I non-sterile, non-measuring devices to the Australian Register of Therapeutic Goods (ARTG).
 
Sponsors now need to provide a manufacturer’s Declaration of Conformity when they apply to add a device to the ARTG. The change coincided with revisions to make the Declaration of Conformity “more user-friendly.”
 
TGA disclosed the changes alongside details of other revisions. In its summary of the changes, TGA said it may conduct non-mandatory audits of Class I applications if it has concerns that a product is not a medical device, is incorrectly classified or does not comply with the essential principles.
 
The revisions only apply to Class I non-sterile, non-measuring devices but that could change. TGA said the new process does not apply to Class 1 IVD medical devices, Class I export only and Class I IVD export only devices “at this stage.”
 
TGA Notice
 
Other News:
 
India’s Directorate General of Foreign Trade (DGFT) has updated its export quota for viral transport media (VTM) and other diagnostic materials used in COVID-19 tests. The VTM quota for September to November is 15 million kits. DGFT previously set a quota of 23.8 million VTM kits for the month of August. DGFT also revised its quotas for RNA extraction and RT-PCR kits. DGFT Notice
 
TGA is reviewing the instructions for use and training documents of laparoscopic power morcellators. The review will assess if the materials are aligned with current safety advice on the products, which regulators have focused on in recent years due to the risk of spreading malignant cells  during hysterectomy or myomectomy to treat uterine fibroids. TGA Notice
 

 

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