Asia-Pacific Roundup: TGA officers execute search warrant in compounded semaglutide investigation

Australia’s Therapeutic Goods Administration (TGA) has provided an update on its investigation into substandard compounded semaglutide, revealing that its officers have executed a search warrant on a residence in Sydney.

At the end of March, TGA reported the results of tests of vials of the GLP-1 drug semaglutide that were linked to the hospitalization of a patient with peripheral neuropathy. The vials, which purported to be compounded, were substandard and contained the wrong amounts of two ingredients, L-carnitine and B12.

Last week, TGA provided an update on the investigation. TGA officers seized “several items” during their search of the Sydney residence and took them for further analysis and examination. The agency is yet to provide information about the items.

TGA performed the search as part of an ongoing investigation into the alleged unlawful manufacture, supply, and export of therapeutic goods. The alleged illegal activities include “medical professionals in Australia and overseas being sent faxes promoting the medicines.”

“Not only have health professionals been duped into believing this was a legitimate pharmacy, but they have then referred their patients to have their prescriptions filled. Some patients have also suffered additional medical issues caused by this substance,” Professor Anthony Lawler, deputy secretary of the Department of Health and Aged Care and head of the TGA, said.

TGA Notice

Philippine FDA seeks feedback on classification of drug distribution deficiencies

The Philippine Food and Drug Administration (FDA) has launched a consultation into planned classifications of deficiencies found in inspections of distributors and other organizations that handle non-prescription drugs.

FDA previously published an order to adopt the World Health Organization’s good distribution and storage practices and revised its guidelines on the cold chain management. Citing those documents and an executive order, FDA said it is imperative that the classification of deficiencies is consistent and guided by distribution and storage practices.

This led the agency to publish draft guidance that is intended to “provide uniform understanding in the classification of noted non-conformances” during inspections of drug distributors and other groups that are subject to good distribution and storage practices.

The guideline defines the terms deficiency, major deficiency and critical deficiency, explaining that the latter term is reserved for departures from good distribution and storage practices that “led or may lead to a significant risk of causing a pharmaceutical product to be harmful to human or animal patients or public health.” FDA is also proposing to treat fraud and other illegal acts as critical deficiencies.

Another section of the guideline explains the type of actions FDA may tell an organization to take when it finds a critical deficiency. Companies may need to temporarily stop the distribution of affected products, recall batches related to the critical deficiency and submit a corrective action and preventive action (CAPA) plan within 15 working days.

“Critical findings shall result in the FDA imposing subsequent regulatory action, including disapproval of the application, or, after notice and hearing, suspension, or revocation of the issued authorization,” FDA wrote in the guideline.

FDA will class a deficiency as major if it has a direct impact on the quality or efficacy of pharmaceutical products. The agency will designate deficiencies that are neither critical nor major as “other.” Multiple other deficiencies can add up and lead FDA to find a company has a major deficiency, despite no single failing meeting the definition for that category.

When inspectors find major and other deficiencies, they may tell the organization to address the issues, including by submitting a CAPA plan and objective evidence of compliance within 15 working days. FDA will take “appropriate regulatory actions” against companies that fail to comply with the request.

FDA is accepting feedback on the draft until 8 May.

Draft Guideline

CDSCO asks private testing labs to register under India’s medical devices regulations

India’s Central Drugs Standard Control Organization (CDSCO) has written to private testing laboratories to ask them to register under the Medical Devices Rule (MDR), 2017.

The regulator explained that “certain private testing labs have been registered under MDR, 2017 for testing and examination of certain medical devices in the country on behalf of the manufacturer.” To strengthen the network, CDSCO wrote to MDR unregistered organizations that it identified as having the ability to carry out various tests of medical devices.

CDSCO wants the organizations to submit applications for “registration of testing laboratory [on] behalf of the manufacturer” and pay the associated fees. The regulator said action is “necessary.” Under MDR, 2017, devices undergo various tests, including assessments of their physical, chemical, mechanical, and electrical properties.

CDSCO Notice

‘New Start of the PMDA’ as Japanese regulator celebrates 20th anniversary

Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) has outlined an updated strategy as part of the celebration of its 20th anniversary.

PMDA began operations in April 2004. The agency, which began with a team of around 250 people, and the industries it regulates have undergone significant changes since then, leading PMDA to adopt a “new purpose.” PMDA sees the changes as a way to respond flexibly to the evolution of the pharmaceutical, medical device and regenerative medicine sectors.

The agency has adopted the brand message “make everyone’s brighter lives” and is preparing a new logo to reflect the revised purpose. PMDA plans to take measures to promote understanding of the purpose inside and outside the organization. The agency provided an update on its plans to open an office in Washington, DC, plus a training hub in Bangkok.

Press Release

Other News:

TGA has updated its guidelines for assessed listed medicines. The group of products sits between lower-risk listed and higher-risk registered medicines and are registered in the Australian Register of Therapeutic Goods without needing to meet the requirements for full registration. TGA has updated the guidelines with information on the data protection scheme and comparable overseas body process. TGA Notice

Malaysia’s Medical Device Authority (MDA) has canceled a circular that exempted COVID-19 tests from the compliance assessment process. All applications for the registration of COVID-19 test kits must now contain the findings of a compliance assessment body. MDA Notice (Malay)

Asia-Pacific Roundup: TGA officers execute search warrant in compounded semaglutide investigation

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