Asia Regulatory Roundup: Options for mitigating ventilator shortages

RoundupsRoundups | 21 April 2020 |  By 

Guidance from regulatory agencies in Australia and Malaysia intends to help healthcare systems cope with surging demand for ventilators.
The Australian document builds on an existing effort to balance supply and demand by providing regulatory exemptions to domestically manufactured invasive ventilators. As it will take time for companies to capitalize on those exemptions and bring new ventilators to market, Australia’s Therapeutic Goods Administration (TGA) has shared details of how hospitals can cope in the meantime.
TGA is allowing hospitals to recommission retired ventilators that were included in the Australian Register of Therapeutic Goods, provided they can confirm the performance of the devices according to the manufacturer’s instructions. Alternatively, TGA is open to hospitals using ventilators designed for use in veterinary settings if they are disinfected and the manufacturer confirms they can be used in humans. Hospitals can also use one ventilator to treat two patients as a last resort.
Beyond ventilators, hospitals can also make use of respiratory support devices such as anesthetic machines and continuous positive airway pressure (CPAP) devices.
Anesthetic machines share mechanical similarities to ventilators that, in TGA’s view, make them suitable stand ins. However, hospitals need to monitor carbon dioxide levels, check for the build-up of condensation and monitor for drops in pressure when using anesthetic machines as replacements for mechanical ventilators. As other regulators have noted, CPAP devices may be able to reduce the need for invasive mechanical ventilation by providing patients with respiratory support.
TGA published its advice the day before its counterpart in Malaysia, the Medical Device Authority (MDA), set out its position on how the regulatory toolkit can be used to increase the availability of ventilators. The document describes a Malaysian pathway that permits unregistered medical devices to be imported and placed on the market if existing equipment is unavailable.
The pathway is open to manufacturers of ventilators that are registered for use by major international regulators, such as the US Food and Drug Administration, under either conventional or emergency powers. Locally made ventilators are also eligible. Companies that want to use the pathway need to submit a notification, following a process described in the guidance, and wait to receive an acknowledgement from MDA.
TGA Notice, MDA Guidance
CDSCO staff return to work as Indian government revises restrictions
India’s Central Drugs Standard Control Organization (CDSCO) has told employees to return to work following a loosening of the nationwide lockdown imposed by the Indian government last month.
While the lockdown largely remains in place, the addition of the Indian Ministry of Health and Family Welfare to the list of organizations that can “function without any restrictions” means the situation at CDSCO has changed. The change will affect its regular and contractual staff, according to the regulator.
As of Monday 20 April, the “absence from duty” of regular CDSCO staff will be handled under rules on leave for people employed by India’s central civil service. Contractual staff who do not attend the office from Monday onward will not be paid.
To gauge compliance with the demand, CDSCO has asked field offices to submit a weekly statement of staff attendance every Friday. The requirement for weekly reporting will stay in place until further notice.
CDSCO Notice
Philippine FDA starts postmarket validation of COVID-19 antibody tests
The Philippine Food and Drug Administration (FDA) has begun postmarket validation of the performance of COVID-19 antibody test kits that come to market via a pandemic pathway.
Last month, the agency began granting special certification to imported in vitro diagnostics for use in testing related to COVID-19. The pathway enabled companies to bring tests to market in the Philippines on the strength of registration issued by a foreign regulator, a valid license to operate, a letter of intent about exemption from registration and a fee.
That set of requirements remains in place but companies that use the pathway now face postmarket scrutiny. Specifically, the agency wants companies to send it 300 test kits within 30 days of the notice of submission. Companies that fail to comply with that demand will have their certifications revoked.
Kits will be tested at the Research Institute for Tropical Medicine. Certification will be revoked if a test fails to meet the required standards. COVID-19 test developers will bear the cost of validating the performance of their products.
FDA Notice
India: ‘absolutely no need to panic’ about hydroxychloroquine availability
The Indian Ministry of Health and Family Welfare has told the public there is “absolutely no need to panic” about the availability of the potential COVID-19 treatment hydroxychloroquine.
The drug has emerged a high-profile potential treatment for COVID-19 and been granted emergency authorization in the US. India, a key supplier of hydroxychloroquine, initially blocked exports of the drug but has since lifted the ban and begun shipping it to 55 countries.
Following the U-turn, India has moved to reassure the public about domestic availability. As India is, in its government’s words, “one of the largest suppliers of active pharmaceutical ingredients and formulations globally,” officials are telling people not to panic.
India is using hydroxychloroquine in two contexts. Firstly, physicians are giving the drug to intensive-care unit patients who have severe COVID-19. Secondly, the drug is being prescribed to asymptomatic healthcare workers in under a “protocol for prophylaxis.”
CDSCO Notice
CDSCO relaxes notary requirement in light of pandemic
CDSCO has freed companies from the need to include notarized documents in applications to import or register drugs after learning of the difficulty of providing the documents under India’s nationwide lockdown.
On 24 March, the Indian government implemented a nationwide lockdown, severely restricting activities that take place outside the home. As CDSCO heard from the companies it regulates, that has created problems for importers and manufacturers as they struggle to get documents notarized.
Indian guidance requires companies to submit documents notarized within the country or at one of its embassies as part of a range of applications. With that now presenting a barrier to filing, CDSCO has agreed to allow companies to defer the submission of notarized documents.
Under the new rules, CDSCO will process applications and grant registrations even if a company does not include notarized documents. Companies must file the notarized documents once the COVID-19 crisis has passed.
CDSCO Notice
Other news:
TGA has set out its position on the reuse of face masks and gowns during the COVID-19 pandemic. In TGA’s view disinfection or resterilization alone will not make a device fit for reuse. TGA also thinks such reprocessing actions “may have a severe deleterious effect on the safety and performance of the masks and gowns that may not be obvious to the end user.” TGA Notice
CDSCO has cleared a sponsor to start a clinical trial of plasma taken from patients previously infected with SARS-CoV-2. The regulator is asking people interested in running trials of plasma to contact the Indian Council of Medical Research. CDSCO Notice


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