Asia-Pacific Roundup: WHO calls for action after Asia-made medicines linked to 300 deaths

RoundupsRoundups | 24 January 2023 |  By 

Regulators must take immediate and coordinated action to stop the supply of contaminated over-the-counter cough syrups linked to the deaths of more than 300 children in countries including Indonesia and Uzbekistan, the World Health Organization has asserted.
 
In recent months, WHO has issued three global medical alerts covering substandard liquid dosage drugs. While adverse events were first reported in The Gambia, the quality problems have their roots in Asia. Indian companies were listed as the manufacturers of cough syrups found in The Gambia and Uzbekistan. A local business was named as the source of the contaminated medicines in Indonesia.
 
WHO wants regulators to do more to interrupt the supply of cough syrups contaminated with diethylene glycol and ethylene glycol. The global public health body told regulators and governments to “assign appropriate resources to improve and increase risk-based inspections of manufacturing sites within their jurisdiction in accordance with international norms and standards.” WHO also urges governments to enact and enforce laws to combat the manufacture, distribution and use of substandard medicines.
 
Additionally, WHO urges regulators to detect and remove substandard products identified in its earlier notices, ensure all marketed products are approved and increase market surveillance, including risk-based targeted testing of medicines sold in formal and informal markets.
 
WHO is asking manufacturers and suppliers to act too. The notice urges manufacturers to only purchase “pharmaceutical grade excipients from qualified and bona fide suppliers” and to comprehensively test all materials before use. WHO also wants manufacturers to assure product quality through certificates of analyses and by keep records of all activities.
 
On the supply and distribution side, WHO told companies to always check for signs of falsification and physical condition of medicines, to only handle authorized products from approved sources and to keep full accurate records.
 
The advice reflects a belief that the adverse events “are not isolated incidents.” WHO has received reports of cases of contaminated cough syrups from seven countries in the past four months. The Philippines, Timor Leste and Cambodia also may be affected based on where certain products could be on sale, WHO officials told Reuters.
 
WHO Notice
 
TGA starts evaluating Moderna’s COVID vaccine for transition to full registration
 
Australia’s Therapeutic Goods Administration (TGA) is evaluating an application for full approval of Spikevax, Moderna’s COVID-19 vaccine. Moderna is the first company to submit a request to transition a COVID-19 vaccine from provisional to full approval in Australia, the agency announced 20 January.
 
TGA, like its peers, allowed COVID-19 vaccines to come to market via an abbreviated pathway to address he public health emergency. Moderna and other companies that TGA awarded provisional approval have since submitted longer-term evidence of safety and efficacy to give the regulator a fuller picture of the effects of their vaccines.
 
Moderna now has requested full registration of Spikevax as a primary vaccination course in people aged six years and older and as a booster in people aged 12 years and up. TGA said it will “undertake a rigorous assessment of the safety, efficacy and quality of this vaccine,” which already has full approval in major markets including the US.
 
Also on 20 January, TGA granted provisional approval to Pfizer’s bivalent version of its Comirnaty COVID-19 vaccine. The provisional approval covers the use of the vaccine as a booster dose in people aged 12 years and up.
 
Pfizer submitted data from the ongoing Phase 2/3 trial of the vaccine, including evidence that it elicits an antibody response against Omicron BA.5/5 subvariants and the ancestral strain. TGA also noted the evidence generated from “extensive use” of the vaccine in the US and Europe in recent months.
 
TGA Notice, More
 
Pakistan’s DRAP creates pathway for loaning APIs for testing
 
The Drug Regulatory Authority of Pakistan (DRAP) has created a pathway for companies that want to borrow active pharmaceutical ingredients (APIs) for product development, R&D and stability testing.
 
Last year, DRAP acceded to a request by the Pakistan Pharmaceutical Manufacturers Association to allow the borrowing of APIs, apart from controlled drugs, for use in product development and stability studies run to support regulatory applications. Buying drug substances from “a reliable source” remains DRAP’s preferred approach but it will allow loans “in extraordinary circumstances” beyond a company’s control.
 
The latest notification outlines the paperwork DRAP wants from companies that borrow ingredients. The regulator asks applicants to provide evidence of a loan from a licensed pharmaceutical manufacturer within 15 days of the transaction. Specifically, DRAP wants companies to provide a letter and agreement of the loan with the manufacturer and documents for the procurement of APIs.
 
Companies that have already loaned APIs have 30 days to provide the requested documents to DRAP. The regulator expects companies to present the files when they submit information in the common technical document format.
 
DRAP released details of the loan process alongside news of a new requirement for companies submitting data on pharmaceutical equivalence and comparative dissolution profiles. To harmonize the filings and ensure data integrity, DRAP asks applicants to include an image of the reference product used in the comparative testing. DRAP wants to see the brand, batch number and expiry date.
 
DRAP Notice, More
 
Philippine FDA issues radiation facility inspection guidelines
 
The Philippine Food and Drug Administration (FDA) has released guidelines on the inspection of radiation facilities to operationalize a pandemic-era policy that outlined a risk-based approach and virtual visits.
 
In 2020, FDA adopted interim guidelines on the inspection of radiation facilities to maintain oversight amid the disruption caused by COVID-19. Now, the agency has incorporated some of the concepts into its permanent position, resulting in a “graded approach” that bases oversight on the “nature of hazard and level of risk associated with radiation facilities and activities.”
 
When circumstances prevent on-site inspections, FDA will perform virtual assessments of facilities. The overview of the inspection process covers both on-site and virtual inspections in equal detail. However, FDA only plans to perform remote assessments during events such as “a state of public health emergency or a state of calamity.”
 
FDA Guidelines
 
Indonesia’s BPOM commits to regionalized laboratory system, partnerships to build capacity
 
The Indonesian Food and Drug Authority (BPOM) has implemented a regionalized laboratory system and has committed to partnering with external operations to increase its capacity.
 
Amid an investigation into contaminated cough syrup, BPOM plans to strengthen its testing capabilities. A senior BPOM official will take direct control of the regionalization because the process will require the active involvement of multiple units.
 
The regulator will judge the effectiveness of the new regionalized system on criteria such as turnaround time and capacity. BPOM plans to improve its performance against the metrics through partnerships with laboratories run by other government departments and private businesses.
 
BPOM Notice (Indonesian)

 

© 2023 Regulatory Affairs Professionals Society.

Discover more of what matters to you

2;3;5;23;30;