Asia-Pacific Roundup: Malaysia’s NPRA details pilot project for track and trace system

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| 26 July 2022 | By Nick Paul Taylor 

Malaysia’s National Pharmaceutical Regulatory Agency (NPRA) has updated the industry on plans to run a pilot project for an end-to-end track and trace platform designed to improve on the existing hologram safety label system.
 
The Malaysian government is developing a system that covers the entire supply chain, from product registration holders, manufacturers and importers through to the end user and will begin a six-month pilot program in January.
 
According to NPRA, the system is designed to ensure the supply chain only contains products registered with the Ministry of Health; ensure the availability of supplies and improve distribution efficiency; terminate existing security label contracts; comply with international standards; combat counterfeits; and improve the ability to control medication errors.
 
In a recent update, NPRA explained that the new system will store and verify product release data. The pilot phase will use two data carriers, the GS1 DataMatrix 2D barcode and the hologram FarmaTag security label and cover all vaccines in Malaysia’s national immunization program. NPRA said the use of international standards is important to ensuring effective integration activities, information sharing and system interoperability.
 
The program includes vaccines against hepatitis B, measles, mumps and rubella, typhoid and other pathogens. Exactly what is expected of importers and manufacturers of the products depends on whether they use the GS1 barcode or FarmaTag label. When working with the GS1 barcodes, direct serialization must be carried out, either at the factory in the country of origin, for imports, or at an approved Malaysian plant. Users of the holograms need to attach the security labels and submit the product data.
 
Scanning the unique identification codes will enable the uploading of data on product registration and movement to the government database. The data will support the tracking of products, and verification of their authenticity, at each stage in the supply chain. Records of product-related movements and activities must be implemented at each step of the supply chain.
 
NPRA will revise the information provided to date based on the needs and development of the system. Full implementation guidelines for the system are planned for after the completion of the pilot project in June 2023.
 
NPRA Notice (Malay)
 
TGA provisionally approves Moderna, Novavax COVID-19 vaccines in younger age groups
 
Australia’s Therapeutic Goods Administration (TGA) has provisionally approved the Moderna COVID-19 vaccine for infants aged 6 months and older and the Novavax vaccine in children aged 12 years and older.
 
Moderna secured the first approval after showing TGA data from the KidCOVE trial, which enrolled more than 6,000 children aged six months to six years at sites in Canada and the US. The trial found the immune response in children was similar to that in young adults aged 18 to 25 years “with a favorable safety profile,” TGA said. Most adverse events were mild to moderate in severity and included irritability, crying and redness at the injection site, typically after the second dose.
 
About a week later, TGA provisionally approved Novavax’s Nuvaxovid for use in youths aged 12 to 17 years. The filing, which submitted by Biocelect on behalf of Novavax, used data on more than 2,200 youths aged 12 to 17 years enrolled in a phase 3 trial of Nuvaxovid in the US.
 
TGA Notice, More
 
Pakistan seeks feedback on changes to regulation of medicine import and export fees
 
The Drug Regulatory Authority of Pakistan (DRAP) is gathering comments on plans to change sections on fees in the rules on imports, exports and appellate boards.
 
Currently, the two sets of rules list specific fees for certain regulatory services. For example, the Drugs (Import & Export) Rules, 1976 lists fees for applications for licenses to import and export drugs and to obtain a duplicate copy of a defaced, damaged or lost license. DRAP is planning to remove the specific fees associated with the services from the rules.
 
In place of the fees listed in rupees, DRAP is proposing to insert the text “as notified by the Authority under the Drug Regulatory Authority of Pakistan (Levy of Fee and Charging) Rules, 2022.” The change will enable DRAP to set the fees for a range of services in a dedicated document, rather than in the texts on each of its specific services.
 
As of 26 July, the only references to the Levy of Fee and Charging rules indexed by search engines are from the proposed updates to the texts on imports, exports and appellate boards. DRAP uploaded the draft amendments on July 21 for a seven-day consultation.
 
DRAP Notice
 
Contrast shortage to last through 2022, TGA warns
 
TGA has warned the end date for the shortage of iodinated contrast media diagnostic agents is uncertain and usual supply is unlikely to resume before the end of the year.
 
Australia, like other countries, suffered shortages of the diagnostic agents after the lockdown in Shanghai affected output at a GE Healthcare facility. GE has since resumed full production and TGA has moved to mitigate the impact of the disruption by authorizing the use of overseas-registered contrast diagnostic agents sold by Guerbet, Bayer and GE.
 
However, in an update last week, TGA advised that the changes are unlikely to resolve the situation in the near term. The disrupted supply chain means orders placed with sponsors will continue to be constrained to ensure the continuity of supply. TGA is advising hospitals and radiology services providers to continue conserving stocks and contact sponsors if they experience “extremely low stock levels.”
 
TGA Notice
 
TGA updates nitrosamine impurity page with details of manufacturing requirements
 
TGA has updated its information on nitrosamine impurities for sponsors and manufacturers. The agency has added information about its own response and the requirements for medicine sponsors and manufacturers.
 
The latest version of the page features a list of acceptable intake limits for various nitrosamines derived from animal carcinogenicity studies. Some limits are based on studies of the actual nitrosamine impurity, while others are extrapolated from closely related nitrosamine compounds. The list features 20 acceptable intake limits.
 
TGA is advising sponsors and manufacturers to use the figures in combination with the maximum daily dose, as set out in the product information, to calculate the limit in parts per million. In the absence of a product information sheet, companies should provide clinical justification for the maximum dose.
 
TGA Update
 
Other news:
 
Pakistan has set a maximum retail price for two forms of remdesivir, the COVID-19 antiviral sold by Gilead Sciences as Veklury. The maximum price is set at 1,892 PKR per vial (USD 8.13). DRAP Notice

 

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