Asia-Pacific Roundup: Philippine FDA seeks feedback on adopting WHO guidelines on postapproval changes
The Philippine Food and Drug Administration (FDA) is proposing to incorporate World Health Organization (WHO) guidelines on postapproval changes to human vaccines and biotherapeutic products into its own rules and is seeking public comment on the proposal.WHO rules and regulations on the registration of vaccines and biological products already apply in the Philippines. FDA also has worked with other Association of Southeast Asian Nations (ASEAN) member states to adopt regionally harmonized rules on the application process and requirements for postapproval changes for registered pharmaceutical products.
However, the ASEAN text and other postapproval documents cover small-molecule medicines. FDA sees a need for postapproval guidance specific to vaccines and biotherapeutics because of the “complexity and current challenges of global life-cycle management” of the products.
To achieve that goal, FDA has released a draft circular intended to “promulgate the revised requirements in instituting postapproval changes to registered biological products, incorporating the WHO and country-specific requirements.” The circular is also intended to provide an application process for making postapproval changes.
In the circular, FDA defines seven terms and then provides “implementing details.” The details, which form the centerpiece of the draft, briefly establish which products are covered by the text and then set out the classifications of variations.
FDA wants all postapproval changes to be based “on the latest version of the WHO Guidelines for Changes to Approved Vaccines and Biotherapeutic Products and country-specific regulations.” The draft breaks the different types of variation — major, minor, prior approval and notification — into two groups, one from the WHO guidelines and one from the country-specific guideline.
Across the rest of the document, the regulatory administration describes the application processes that apply to the different types of variations and the requirements that applicants need to meet. Once in use, the FDA guidelines will apply to all incoming postapproval change submissions but not to filings that are already awaiting review by the administration.
FDA will accept feedback on the draft until 15 August.
FDA Notice
India’s CDSCO answers questions on newly implemented requirements to add QR codes
India’s Central Drugs Standard Control Organization (CDSCO) has answered questions on the requirement for manufacturers of the top 300 medicine brands to add a barcode or QR code to their product labels.
In November, the Indian government adopted changes to its drug regulations that listed 300 medicines that would need to carry a barcode or QR code on their primary packaging label by 1 August 2023. The government wanted the codes, which the rules permitted to be printed on secondary labeling in certain circumstances, to carry information such as the unique product identification code and expiry date.
“This notification is applicable for all the indigenous as well as foreign manufacturers who are manufacturing these brands of drug formulations for marketing in the country,” CDSCO wrote in an FAQ published days before the 1 August implementation. “Any batch of brands of the drug formulations as specified in the notification which has been manufactured on or after 1st day of August 2023, irrespective of the location of the manufacturing site, shall have the Barcode or QR code on its label as per the said notification.”
Indian pharma manufacturers have a history of successfully lobbying for delays to the implementation of regulatory requirements. However, the requirement to add barcodes or QR codes to certain brands looks set to be implemented as planned. On 31 July, the Indian business newspaper Mint reported that the Indian Drugs Manufacturing Association has directed its members to follow the new guidelines.
CDSCO FAQ
TGA removes information from website after Australian court sides with mask company
Australia’s Therapeutic Goods Administration (TGA) has removed information about certain batches of disposable face masks from its website after the product’s sponsor took the regulator to court.
TGA published information regarding the product 1 year ago. The sponsor, M House Pty Ltd, claimed in Federal Court that the release of information was not authorized under Section 61(5C) of the Therapeutic Goods Act 1989.
The court agreed. Its decision rested on the assertion that information about sampling and testing can only be released if the work is performed under Part 5 of the Therapeutic Goods Regulations 1990.
TGA has the right to appeal the decision.
TGA Notice
CDSCO calls out cough syrup manufacturer for ‘highly objectionable’ approach to testing
India’s CDSCO has criticized a manufacturer of cough syrup for export over a “highly objectionable” and “not acceptable” approach to product testing.
Cough syrups must be tested by an accredited laboratory before export, under Indian regulations. That mandate has caused backlogs at authorized sites and led at least one manufacturer to seek a creative solution.
On 28 July, CDSCO wrote to all manufacturing associations and exporters, noting that “samples of the same batch number, manufactured by the same manufacturer (for export purposes)” had been sent to two separate laboratories for testing, and that such a practice was “highly objectionable.”
If the regulator learns of other companies sending products to two laboratories, “the samples of those manufacturers/exporters shall not be accepted for testing by any of the NABL accredited government laboratories.”
CDSCO Notice
PMDA posts alert about DPP-4 inhibitors after skin condition hospitalizes diabetes patient
Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) has issued an alert about the safety of dipeptidyl peptidase-4 (DPP-4) inhibitors after reviewing the events that led to the hospitalization of a patient.
DPP-4 inhibitors are a class of treatments for type 2 diabetes that includes Kyowa Kirin’s Onglyza and Merck & Co.’s Januvia. Pemphigoid, a skin condition, is a known adverse reaction to DPP-4 inhibitors. The Japanese labels of products containing DPP-4 inhibitors refer to the risk and advise precautions.
However, PMDA has received reports of cases in which patients continued to take the treatments even after they developed early signs of pemphigoid. One patient was hospitalized because of the continued administration of a DPP-4 inhibitor.
In response, PMDA is advising healthcare professionals to consult a dermatologist immediately if a patient develops symptoms. Healthcare professionals should also take “appropriate measures, such as discontinuation of administration.”
PMDA Alert
Other news:
TGA has shared details of a shortage of Novo Nordisk’s Norditropin FlexPro in Australia. Manufacturing issues mean supply could be disrupted until the end of the year. TGA Notice
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