Asia-Pacific Roundup: New Zealand bans unapproved COVID vaccines

RoundupsRoundups | 04 May 2021 |  By 

The New Zealand Medicines and Medical Devices Safety Authority (Medsafe) has banned the trade in unapproved COVID-19 vaccines for a year to prevent the use of vaccines that may not be safe or effective.
Only Comirnaty (Pfizer/BioNTech) is approved for use in New Zealand; vaccines from AstraZeneca and Johnson & Johnson currently are under rolling review. The ban on the importation, manufacture, packing, sale, supply, possession, administration or use of unapproved COVID-19 vaccines therefore applies to all other vaccines, as well as to parallel imports of Comirnaty. Medsafe framed the action in the context of public safety.
“In order to ensure the public has a reliable supply of vaccine, it is considered important to close off other supply routes that may increase the risk that a vaccine will be unsafe or ineffective. Unsafe or ineffective vaccines would reduce New Zealand’s protection against COVID-19, both for people at high risk and for the whole community,” Medsafe wrote.
The restrictions apply to importers, manufacturers, suppliers, healthcare practitioners and the public and close off several routes for getting vaccines into the country. In the absence of the ban, people could use section 25 and 29 of the Medicines Act 1981 to import, administer or supply unapproved COVID-19 vaccines. The public could also import personal supplies of vaccines. Medsafe’s action prohibits the trade in COVID-19 vaccines via those routes until 27 April 2022.
Medsafe imposed the ban by issuing a section 37 notice. Anyone convicted of breaching the trade restriction could face up to three months in prison and a fine of up to NZ$500. People and organizations that breach the ban may also face punishment under other parts of the law, which carry prison terms of up to six months and fines for companies of up to NZ$100,000 ($72,000).
Vaccines distributed to obtain clinical and scientific information are exempt from the ban, as are the activities of pharmacists “in relation to packing, labelling and supply of the consented or provisional consented vaccine.”
Medsafe Notice

Philippine FDA seeks feedback on renewal of GMP clearance guidelines

The Philippine Food and Drug Administration (FDA) is seeking feedback on interim guidelines on the renewal of current good manufacturing practice (cGMP) clearance of foreign drug manufacturers.
FDA changed its approach to cGMP clearance last year because the pandemic impeded its ability to conduct in-person inspections of manufacturing facilities. The pandemic’s continuing impact on travel and in-person interactions led FDA to issue revised guidelines that, once finalized, will apply until the end of the year.
In the draft guidelines, FDA proposes extending the validity of “the cGMP clearances for foreign drug manufacturers issued by the FDA of all incoming renewal applications” until 31 December. FDA will process applications with a longer validity than the end of the year.
Applications for renewal of cGMP clearance that are submitted next year will be subject to a “surcharge or penalty equivalent to twice the renewal cGMP clearance fee,” plus an additional fee that will keep rising until the paperwork is submitted or 120 days pass. Companies that fail to file in 120 days will face additional penalties and potentially regulatory actions. 
FDA is accepting feedback on the draft until 17 May.
Draft Guidelines

TGA warns of unlawful advertising of listed medicines

Australia’s Therapeutic Goods Administration (TGA) has issued a warning about unlawful advertising of listed medicines, issuing the warning on the same day it disclosed a AU$119,880 ($92,733) fine for Global Therapeutics over the advertising of listed complementary medicines.
Sponsors cannot advertise listed medicines that are not included in the Australian Register of Therapeutic Goods (ARTG) with permitted indications, according to the warning. On 6 March, some listed medicines were transitioned to permitted indications. Other listed medicines were cancelled from the ARTG, creating a new regulatory situation for sponsors.
“Only permitted indications included in the ARTG entry may be advertised, and it is unlawful to advertise any medicines for free text or coded indications that were previously included in the ARTG,” according to TGA.
TGA fined Global Therapeutics’ for its alleged use of “unapproved references to 'serious' conditions such as upper respiratory tract infections, bronchitis, influenza, and viral and bacterial infections.” The  company allegedly advertised medicines for indications other than those accepted in the ARTG.
The action against Global Therapeutics stemmed from TGA’s monitoring of the ARTG. The agency added that it is continuing to actively monitor for noncompliance with the advertising requirements. 
TGA Notice, More

TGA lifts suspension of Tandem t:slim X2 insulin pump, with conditions

TGA has lifted the suspension it imposed on the Tandem t:slim X2 insulin pump late last year. The action follows an investigation into battery issues and the adoption of measures intended to mitigate the concerns.
Starting in September 2019, TGA detected an increase in complaints about unexpected shutdowns of t:slim devices, fast battery depletion and overheating during charging. TGA responded to the reports by suspending the ARTG listing, limiting supply to new patients. Australasian Medical & Scientific, the local distributor of the device, has worked with TGA since then to resolve the problem.
TGA now has cleared the supply of devices that were made on or after 1 August and use the software version Basal-IQ 6.4.1. In addition, TGA is requiring the sponsor to report all Australian adverse events for 12 months.
TGA Notice

CDSCO seeks details of diagnostic supply amid pandemic-fueled rise in demand

India’s Central Drugs Standard Control Organization (CDSCO) has requested information on the supply of tests for inflammatory biomarkers in response to rising demand for the tests as COVID-19 cases surge in the country.
Healthcare professionals use tests for biomarkers such as IL-6, D-dimer and CRP to inform the care of patients with COVID-19. With the seven-day rolling average of new COVID-19 cases in India rising from around 11,000 in mid-February to 370,000 as of 4 May, demand for inflammatory tests has increased. Local media outlets have reported shortages.
Days after the media reports, CDSCO asked manufacturers and importers of tests and reagents to operate at maximum capacity. CDSCO also asked companies for their current stock and capacity, as well as their proposed capacity, for IL-6, D-dimer and CRP reagents and tests.
CDSCO Notice

Other news

The Drug Regulatory Authority of Pakistan (DRAP) has stopped accepting hard copies of applications for new drug manufacturing licenses. As of 3 May, DRAP will only accept filings through the Pakistan Integrated Regulatory Information Management System (PIRIMS). Companies can use PIRIMS to file various regulatory applications and submit the associated fees. DRAP Notice, More
TGA has warned Australian consumers about the potential harms of unlawfully supplied medicinal cannabis. The notice urges consumers to beware of fake medicinal cannabis sold online. TGA Notice


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