Asia-Pacific Roundup: TGA fines companies over rapid COVID test imports

Australia’s Therapeutic Goods Administration (TGA) has fined two companies a total of AU$39,960 ($29,440) over alleged infringements including the unlawful importation of rapid COVID-19 tests into Australia.
 
One of the companies, CheckMe, allegedly imported around 57,000 rapid antigen tests (RATs) that were not in the Australian Register of Therapeutic Goods (ARTG) when they entered the country. The were a parallel import of a similar Australian-approved product. Officials seized the tests at the border, resulting in an estimated financial impact to the business of AU$100,000.
 
TGA disclosed its AU$13,320 infringement notice to CheckMe on the same day as it revealed its action against G1 Resources, a company in Western Australia that is accused of importing 600 RATs that were similar to an Australian approved product but not included in the ARTG. TGA used the issuance of the infringement notices as an opportunity to remind the industry of the rules on RATs.
 
“This matter serves as a reminder to businesses to only purchase stock of therapeutic goods approved for the Australian market. Any RATs imported for commercial supply must be the version manufactured and approved for the Australian market and not a parallel import. The RATs must be included in the ARTG under the name of the supplier, prior to importation,” TGA wrote.
 
The warnings echo events in the US, where the Food and Drug Administration has warned people against using European versions of certain tests. The affected companies have emergency use authorizations to sell tests in the US but unapproved European versions of their kits entered the country. Tests are widely available in Europe but were in short supply as the US contended with a winter Omicron wave.
 
TGA’s actions also included an infringement notice to G1 about the alleged unlawful advertising of RATs. According to TGA, G1 allegedly advertised on its website various pack sizes of a RAT that was not included in the ARTG. RATs must be included in the ARTG before being advertised. The allegation led to a second infringement notice, bringing the total G1 fine up to AU$26,640.
 
G1 Notice, CheckMe Notice
 
Pakistan seeks feedback on finished product labeling and packaging guidelines
 
The Drug Regulatory Authority of Pakistan (DRAP) is seeking feedback on draft guidelines for labeling and packaging finished drug products. DRAP created the text to provide advice on how to ensure the information on the label and package leaflet is accessible to, and can be understood by, patients. .
 
DRAP aims to support the safe, appropriate use of medicines, as well as making labeling and packaging content consistent, transparent, clear, efficient and high quality, and to help marketing authorization holders to draw up their leaflets.
 
DRAP has created a draft that describes the information that needs to appear on a product label, such as the registered name of the drug, and how the requirements differ depending on whether a medicine is for internal, external or parenteral use. The guideline also features specific rules for drugs for government supply, products that come in pressurized containers and physician’s samples.
 
The draft also addresses the rules on brand names. DRAP wants companies to avoid names that could be confused other medicinal products. The draft also bans names that convey misleading therapeutic connotations or promotional messages.
 
DRAP is accepting feedback until 30 April.
 
DRAP Notice
 
Malaysia’s MDA opens draft medical device labeling guidance for public comment
 
Malaysia’s Medical Device Authority (MDA) is seeking feedback on draft requirements for the labeling of medical devices. The fifth edition of the guidance features changes to the rules on the general contents of labeling and to other sections of the text.
 
In the draft, MDA proposes to allow certain information to be provided in the form of an insert, “after applying risk management as according to ISO 14971.” The ISO standard addresses the application of risk management to medical devices. MDA’s proposal covers information such as the instructions for use, any postmarket servicing needs of the device, and any undesirable side effects, limitations or warnings.
 
Other parts of the section on general contents of labeling have undergone minor changes. MDA wants to use the draft to clarify that the model of the medical device is among the details that should be included, and to revise its wording on the provision of contact information for the manufacturer and authorized representative.
 
MDA also used the update to propose changing its position on the use of the local language, with the text now stating that “if information is provided in the label, the Bahasa Malaysia translation shall be on the label.” Other changes include the addition of examples of acceptable formats for displaying the registration number.
 
MDA is accepting feedback until 28 April.
 
MDA Notice
 
Pakistan starts consultation about bioavailability bioequivalence guidelines
 
Pakistan’s DRAP has opened its draft guidelines on bioavailability and bioequivalence studies for generic drug products for comment. The document covers the in vivo and in vitro tests needed to assure the interchangeability of generic and reference products.
 
In the draft, DRAP defines when equivalence studies are needed and the type of studies that developers must run. DRAP regards a comparative pharmacodynamic study or clinical trial as “especially important” for some active pharmaceutical ingredients and dosage forms. Such in vivo evidence is needed when there is “a risk that possible differences in bioavailability may result in therapeutic inequivalence.”
 
Most of the draft addresses the specifics of in vivo studies, covering topics such as study standardization and how to approach trials of immediate- and modified-release formulations. A section near the end addresses in vitro equivalence testing, which DRAP said may be appropriate for some products.
 
DRAP  is accepting feedback on the draft until 30 April.
 
DRAP Notice
 
NPPA seeks partner to track availability of medicines across India’s supply chain
 
India’s National Pharmaceutical Pricing Authority (NPPA) has put out a tender for a project to track “the availability of specified medicines in the supply chain across the country.”
 
The tender grew out of the constraints NPPA faced when trying to track stocks of medicines during the pandemic. As NPPA sees it, the problem is twofold: it needs to track both where medicines are in the supply chain and as well as in what quantities. NPPA is seeking a contractor that can collect and analyze data on the production, sales and stocks of selected drugs.
 
NPPA wants the contractor to develop and operate a National Pharma Dashboard that manufacturers and other stakeholders can use to publish their stock positions “as per need or mandate on declared frequency.” The authority wants the dashboard to provide “a national level representation of the availability of essential medicines.”
 
NPPA published the tender on the same day as it resurrected its request for a contractor to study drug pricing policies in different parts of the world.
 
NPPA Tender, More