Regulatory Focus™ > News Articles > 2021 > 1 > Asia-Pacific Roundup: TGA moves to strike redundant, resource intensive processes

Asia-Pacific Roundup: TGA moves to strike redundant, resource intensive processes

Posted 19 January 2021 | By Nick Paul Taylor 

Asia-Pacific Roundup: TGA moves to strike redundant, resource intensive processes

Australia’s Therapeutic Goods Administration (TGA) has outlined plans to eliminate certain redundant, resource intensive processes to lessen the burdens on its teams and the companies it regulates. The proposal centers on information uploaded to a Proprietary Ingredients Table that stores information about mixes of excipients and actives.
 
Today, TGA asks ingredient suppliers to add information to the table by completing a form covering the constituent ingredients of their mixes and the types of product in which they will be used. Most of the mix categories in the table relate to excipients with specific purposes, such as combinations that affect flavor. There are also groupings for active ingredients and excipients without a stated function. The process of adding and validating mixes takes up to 30 working days.
 
TGA is questioning whether that represents a good use of time. The agency does not check if mixes meet regulatory requirements for use in therapeutic goods or evaluate their safety, quality or efficacy. Companies seeking to add products to the Australian Register of Therapeutic Goods can select mixes when filing but equally can choose their constituent ingredients individually.
 
With a mandate to streamline processes, TGA has proposed to stop adding active ingredient mixes and nonspecific excipient mixes to the table. Doing so for active ingredient mixes will spare suppliers from the need to add information to the table. Rather, they will give the sponsor they are working with details of the constituent ingredients.
 
The excipient side of the proposal affects mixes without a defined purpose. Currently, the table has a category for nonspecific mixes, as well as others for combinations used for coatings, flavors and other defined purposes. TGA wants to eliminate the nonspecific category, which it currently thinks is either wrongly used for single ingredients, mixes with a purpose covered by other categories and mixes that fall into more than one category. The nonspecific category causes problems for TGA.
 
“Certain TGA medicine application systems rely on validation rules with limits on ingredients when used in a mixture with a specific purpose (i.e. flavours, fragrances and printing inks). Where these types of ingredients are combined with others in a non-specific Excipient Mix, the electronic system is not able to accurately apply the validation rules to the medicine application,” TGA wrote.
 
Under the revised system, suppliers of mixes with multiple purposes will either create table entries for each function or send the sponsor details of the constituent ingredients for communication in its submission.
 
TGA wants to know if the industry supports the plans and is accepting feedback until 24 February. If the feedback is positive, TGA intends to implement the proposal in the first half of this year. TGA can adopt the policy without making legislative changes.
 
TGA Notice
 
TGA starts assessing accuracy of COVID tests against emerging variants
 
TGA had begun evaluating the ability of COVID-19 tests to detect emerging genetic  variants of the pandemic coronavirus. The investigation follows the emergence of new, likely more transmissible strains in multiple countries.
 
On 8 January, the US Food and Drug Administration (FDA) issued a notice about the risk of COVID-19 tests delivering false negative results if applied to viral samples featuring mutations in the regions of the genome targeted by the diagnostic. FDA said the current impact of the variants on molecular tests is low but that kits made by Applied DNA Sciences, Mesa Biotech and Thermo Fisher Scientific are affected to some extent.
 
Days later, TGA revealed it is conducting its own review of the impact of variants, notably two new forms of the virus found in the UK and South Africa, on the performance of COVID-19 tests. TGA is yet to share findings from the investigation but has released preliminary advice for laboratories and healthcare professionals who may see their results affected by the variants.
 
TGA said variants can potentially change the performance of COVID-19 tests, adding that products designed to detect multiple parts of the genome are less vulnerable to viral evolution than those that target a single region. Most TGA-approved tests target multiple regions. The agency also explained that variants first seen in the UK and South Africa, but now found around the world, are associated with higher viral loads and therefore may generate positive results in fewer PCR-RT thermal cycles.
 
As it stands, TGA is yet to single out any test as a focal point of the investigation. One of the products highlighted by FDA, Thermo Fisher Scientific's TaqPath, is approved in Australia. However, knowledge of the design of TaqPath and experience in the UK suggests the test accurately detects the variants.
 
TaqPath tests for three regions of the SARS-CoV-2 genome. One of the regions is mutated in some variants, including the B.1.1.7 lineage found in the UK. When applied to samples containing B.1.1.7, TaqPath delivers positive results for two of its three target regions. The fact B.1.1.7 gives a negative result for one part of the test, due to S-gene dropout, has enabled the UK to roughly track the rise of the variant based on the number of TaqPath readouts that were positive for two of the three regions.
 
TGA Notice
 
Philippine FDA grants emergency authorization to Pfizer’s Comirnaty vaccine
 
The Philippine Food and Drug Administration (FDA) has granted emergency use authorization (EUA) to the COVID-19 vaccine developed by Pfizer and BioNTech. Pfizer’s Comirnaty is the first COVID-19 vaccine to come to market in the country.
 
In recent weeks, FDA has received applications for EUA of COVID-19 vaccines from Pfizer and later from AstraZeneca. Having committed to decide within 21 days of receiving a filing, FDA has now completed its review of the Pfizer vaccine. The positive EUA decision follows an assessment by the Center for Drugs Regulation and Research.
 
FDA Director General Eric Domingo noted the allergic reactions seen in some of the millions of people around the world who have received the vaccine already. In light of the reactions, FDA wants healthcare professionals with the resources to respond to allergy-related adverse events to give the vaccine.  
 
An FDA decision on AstraZeneca’s application for EUA is expected later this month.
 
FDA Notice
 
Malaysia seeks feedback on medical device categorization guidance  
 
Malaysia’s Medical Device Authority (MDA) hasd released draft guidance on how to pick the correct category for products in registration applications.
 
MDA groups medical devices into four categories. Some devices are classed as “single” because they are a distinct packaged entity with a specific intended purpose. Other products feature a collection of devices that are classified by MDA as a “family.” MDA can also classify a product as a “system” or a “set.”
 
The draft guidance features definitions of the four categories, as well as examples of products that fall into each grouping. To help applicants identify the appropriate category for their products, MDA has created a decision flowchart. The guidance also addresses the grouping of in vitro fertilization technologies, dental devices and hearing aids, each of which has distinct grouping rules.   
 
The draft is open for comment until 28 January.
 
MDA Notice
 
Other News:
 
The Drug Regulatory Authority of Pakistan (DRAP) has granted emergency use authorization to COVID-19 vaccines from AstraZeneca and SinoPharm-subsidiary China National Pharmaceutical Group. DRAP will review the two authorizations every quarter. DRAP Notice
 
An Indian regulatory committee has advised Serum Institute of India to replace the placebo arm of one of its COVID-19 vaccine clinical trials with an active comparator. SEC Recommendations

 

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