Asia-Pacific Roundup: TGA queries on managing medicine shortages, discontinuations
Roundups | 19 February 2024 |
The Therapeutic Goods Administration (TGA) is holding a consultation to understand the problems affecting the supply of medicines in Australia and to identify ways to fix the problems collaboratively.
Australia made it mandatory in 2019 for sponsors to report shortages and permanent discontinuations of all prescription medicines and certain over-the-counter products on the Australian Register of Therapeutic Goods. Since then, TGA has formed partnerships to “solve specific shortage issues, streamline processes and introduce broader long-term improvements to the framework,” the agency said.
“Although many improvements have been made, medicine shortages continue to impact on the health and well-being of people in Australia, and the health professionals who support them,” TGA said. “A strategic work plan for the future is required, to further reduce the impact of medicine shortages and discontinuations in Australia.”
TGA is seeking answers on how sponsors and other health organizations plan for, learn of and respond to medicine shortages and discontinuations. The agency wants to know if respondents monitor medicine availability or track of supply.
TGA also wants feedback on the most significant issues people would like to see fixed regarding medicine shortages, discontinuations and the broader supply chain. The agency is gathering views on its current regulatory framework and soliciting suggestions for improving Australia's medicine shortages and discontinuations.
TGA is accepting responses until 12 March.
TGA Notice
Philippine FDA proposes third delay to medical device deadline to avoid supply disruption
The Philippine Food and Drug Administration (FDA) is planning to delay the deadline for obtaining a Certificate of Medical Device Notification (CMDN) for previously non-registrable Class B, C, and D medical devices.
In 2021, FDA created a pathway for registering devices as part of its implementation of the Association of Southeast Asian Nations (ASEAN) harmonized technical requirements. The agency reportedly established a one-year transition period, giving manufacturers until March 2022 to obtain a CMDN for their Class B, C, and D medical devices.
FDA first gave the industry more time in April 2022 and then pushed the deadline back again in March 2023. “Hence, the medical device industries were given ample time to prepare the necessary technical documentary requirements,” the FDA wrote in its latest notice.
The agency remains concerned that enforcing the timeline set in March 2023 could disrupt the supply of medical devices in the Philippines. In its latest notice, the agency said it “recognizes the importance of assuring that the availability of medical devices will not be affected” and “understands the need to extend the regulatory flexibility to assist the medical device industry in complying with the regulatory requirements.”
Those considerations led FDA to propose allowing Class B, C, and D medical devices to be manufactured, imported, exported, distributed, transferred, sold or offered for sale without a CMDN until 30 September 2024. Under the proposed timeline, companies will have until 30 September to apply for CMDNs.
From 1 October, FDA will stop accepting CMDN applications and require companies to apply for a Certificate of Medical Device Registration (CMDR). Companies will need a CMDN, CMDR or pending application for either type of certificate to supply affected medical devices starting 1 October.
The agency is accepting feedback on the proposals until 22 February.
FDA Notice
Pakistan’s DRAP finds potentially deadly contaminant in excipient batch
The Drug Regulatory Authority of Pakistan (DRAP) has issued another warning about a contaminated batch of the excipient propylene glycol.
DRAP declared the batch substandard after testing by the Central Drugs Laboratory, Karachi, found that it contained unacceptable levels of ethylene glycol (EG) and diethylene glycol (DEG) – contaminants that have been linked to the deaths of more than 100 children globally. The regulator has been clamping down on propylene glycol, ordering a recall after finding a contaminated batch and urging manufacturers to do more (RELATED: Asia-Pacific Roundup, Regulatory Focus, 15 January 2024; Asia-Pacific Roundup, Regulatory Focus, 5 February 2024).
The latest notice was triggered by government-run tests on a sample submitted by Biolabs, a Pakistan-based pharmaceutical company. The batch was allegedly made by China’s Shinghwa Amperex Technology.
DRAP “is investigating the entire supply chain of this batch,” the agency said, and has asked Biolabs to recall “any finished products that were manufactured using the same lot of propylene glycol.” Any other company that made medicines using the same lot should also start a recall. DRAP is asking companies to hold products made with other Shinghwa Amperex lots until they are tested for EG and DEG.
DRAP Notice
Philippine government prepares to shorten generic approval timeline to 45 days
The Philippine government is preparing to sign off on changes that will shorten the review time for some generic drugs from 120 days to 45 days.
In 2022, the Philippine FDA published a circular about its plans to create facilitated registration pathways for new drug applications. That proposal, which excluded filings for approval of generic drugs, described a 45-day abridged review pathway. FDA sought feedback on plans to extend the facilitated registration pathways to generic drugs at the start of the year.
Last week, Samual Zacate, director general of FDA, said he was “on the verge of signing the memorandum circular.” Zacate outlined how the agency will save time by relying on the work of other regulators.
“We do not reduce the number of requirements, but we use reliance. If it came from, say the US [Food and Drug Administration] or [Japan’s Pharmaceutical and Medical Devices Agency], we will look at what they evaluate. The very paper they used, that's what we're going to look at,” Zacate said at a press conference. “When it has satisfactorily complied with the requirements of the ASEAN common technical documents, we will not repeat it because we will rely on a stringent regulatory authority.”
Press Release
CDSCO creates walk-in schedule to hear complaints, fix problems
India’s Central Drugs Standard Control Organization (CDSCO) has created a time for walk-in meetings where “problems, complaints, grievances and suggestions will be heard for suitable and swift resolution.”
Every Tuesday and Thursday from 20 February onward, CDSCO will open its headquarters for unscheduled meetings from 5:00 PM to 6:00 PM. CDSCO framed the initiative as part of the government’s Ease of Doing Business in India agenda.
In 2019, India scored 62 on the most recent World Bank Ease of Doing Business assessment, which assigned a score of 1 to the country with the most business-friendly regulations. (The measure was discontinued in 2021.) Since then, CDSCO has embarked on a digital transformation and otherwise taken steps to make it easier for the pharma industry to do business in India.
CDSCO Notice
Other news:
TGA reported an extension of the shortage of the antidepressant Zactin (fluoxetine 20 mg dispersible tablet) that has affected Australia since late last year. The agency first listed the shortage in November 2023, when it expected normal supply to resume by the end of February 2024. However, the supplier, Alphapharm, has told TGA the disruption will continue until 30 April 2024 because of “manufacturing issues.” TGA Notice
Australia made it mandatory in 2019 for sponsors to report shortages and permanent discontinuations of all prescription medicines and certain over-the-counter products on the Australian Register of Therapeutic Goods. Since then, TGA has formed partnerships to “solve specific shortage issues, streamline processes and introduce broader long-term improvements to the framework,” the agency said.
“Although many improvements have been made, medicine shortages continue to impact on the health and well-being of people in Australia, and the health professionals who support them,” TGA said. “A strategic work plan for the future is required, to further reduce the impact of medicine shortages and discontinuations in Australia.”
TGA is seeking answers on how sponsors and other health organizations plan for, learn of and respond to medicine shortages and discontinuations. The agency wants to know if respondents monitor medicine availability or track of supply.
TGA also wants feedback on the most significant issues people would like to see fixed regarding medicine shortages, discontinuations and the broader supply chain. The agency is gathering views on its current regulatory framework and soliciting suggestions for improving Australia's medicine shortages and discontinuations.
TGA is accepting responses until 12 March.
TGA Notice
Philippine FDA proposes third delay to medical device deadline to avoid supply disruption
The Philippine Food and Drug Administration (FDA) is planning to delay the deadline for obtaining a Certificate of Medical Device Notification (CMDN) for previously non-registrable Class B, C, and D medical devices.
In 2021, FDA created a pathway for registering devices as part of its implementation of the Association of Southeast Asian Nations (ASEAN) harmonized technical requirements. The agency reportedly established a one-year transition period, giving manufacturers until March 2022 to obtain a CMDN for their Class B, C, and D medical devices.
FDA first gave the industry more time in April 2022 and then pushed the deadline back again in March 2023. “Hence, the medical device industries were given ample time to prepare the necessary technical documentary requirements,” the FDA wrote in its latest notice.
The agency remains concerned that enforcing the timeline set in March 2023 could disrupt the supply of medical devices in the Philippines. In its latest notice, the agency said it “recognizes the importance of assuring that the availability of medical devices will not be affected” and “understands the need to extend the regulatory flexibility to assist the medical device industry in complying with the regulatory requirements.”
Those considerations led FDA to propose allowing Class B, C, and D medical devices to be manufactured, imported, exported, distributed, transferred, sold or offered for sale without a CMDN until 30 September 2024. Under the proposed timeline, companies will have until 30 September to apply for CMDNs.
From 1 October, FDA will stop accepting CMDN applications and require companies to apply for a Certificate of Medical Device Registration (CMDR). Companies will need a CMDN, CMDR or pending application for either type of certificate to supply affected medical devices starting 1 October.
The agency is accepting feedback on the proposals until 22 February.
FDA Notice
Pakistan’s DRAP finds potentially deadly contaminant in excipient batch
The Drug Regulatory Authority of Pakistan (DRAP) has issued another warning about a contaminated batch of the excipient propylene glycol.
DRAP declared the batch substandard after testing by the Central Drugs Laboratory, Karachi, found that it contained unacceptable levels of ethylene glycol (EG) and diethylene glycol (DEG) – contaminants that have been linked to the deaths of more than 100 children globally. The regulator has been clamping down on propylene glycol, ordering a recall after finding a contaminated batch and urging manufacturers to do more (RELATED: Asia-Pacific Roundup, Regulatory Focus, 15 January 2024; Asia-Pacific Roundup, Regulatory Focus, 5 February 2024).
The latest notice was triggered by government-run tests on a sample submitted by Biolabs, a Pakistan-based pharmaceutical company. The batch was allegedly made by China’s Shinghwa Amperex Technology.
DRAP “is investigating the entire supply chain of this batch,” the agency said, and has asked Biolabs to recall “any finished products that were manufactured using the same lot of propylene glycol.” Any other company that made medicines using the same lot should also start a recall. DRAP is asking companies to hold products made with other Shinghwa Amperex lots until they are tested for EG and DEG.
DRAP Notice
Philippine government prepares to shorten generic approval timeline to 45 days
The Philippine government is preparing to sign off on changes that will shorten the review time for some generic drugs from 120 days to 45 days.
In 2022, the Philippine FDA published a circular about its plans to create facilitated registration pathways for new drug applications. That proposal, which excluded filings for approval of generic drugs, described a 45-day abridged review pathway. FDA sought feedback on plans to extend the facilitated registration pathways to generic drugs at the start of the year.
Last week, Samual Zacate, director general of FDA, said he was “on the verge of signing the memorandum circular.” Zacate outlined how the agency will save time by relying on the work of other regulators.
“We do not reduce the number of requirements, but we use reliance. If it came from, say the US [Food and Drug Administration] or [Japan’s Pharmaceutical and Medical Devices Agency], we will look at what they evaluate. The very paper they used, that's what we're going to look at,” Zacate said at a press conference. “When it has satisfactorily complied with the requirements of the ASEAN common technical documents, we will not repeat it because we will rely on a stringent regulatory authority.”
Press Release
CDSCO creates walk-in schedule to hear complaints, fix problems
India’s Central Drugs Standard Control Organization (CDSCO) has created a time for walk-in meetings where “problems, complaints, grievances and suggestions will be heard for suitable and swift resolution.”
Every Tuesday and Thursday from 20 February onward, CDSCO will open its headquarters for unscheduled meetings from 5:00 PM to 6:00 PM. CDSCO framed the initiative as part of the government’s Ease of Doing Business in India agenda.
In 2019, India scored 62 on the most recent World Bank Ease of Doing Business assessment, which assigned a score of 1 to the country with the most business-friendly regulations. (The measure was discontinued in 2021.) Since then, CDSCO has embarked on a digital transformation and otherwise taken steps to make it easier for the pharma industry to do business in India.
CDSCO Notice
Other news:
TGA reported an extension of the shortage of the antidepressant Zactin (fluoxetine 20 mg dispersible tablet) that has affected Australia since late last year. The agency first listed the shortage in November 2023, when it expected normal supply to resume by the end of February 2024. However, the supplier, Alphapharm, has told TGA the disruption will continue until 30 April 2024 because of “manufacturing issues.” TGA Notice
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