Asia Regulatory Roundup: India Opens Regulatory Fast Track to COVID-19 Drugs, Vaccines and Diagnostics

Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia.
 
India Opens Regulatory Fast Track to COVID-19 Drugs, Vaccines and Diagnostics
 
The Central Drugs Standard Control Organization (CDSCO) of India has unveiled a series of actions designed to accelerate development of drugs, vaccines and diagnostics for use in the management of the COVID-19 pandemic.
 
Like many of its peers, CDSCO wants to work with developers of products related to the SARS-CoV-2 virus to truncate timelines and remove some of the barriers companies typically need to clear to get to market. With that goal in mind, CDSCO has published seven changes it is making to help drug and vaccine developers, plus five actions aimed at the diagnostic sector.
 
On a case-by-case basis, CDSCO may agree to abbreviate, defer or waive the need for developers of drugs and vaccines to generate animal toxicity, clinical, stability and other types of data. CDSCO has extended a similar offer to developers of COVID-19 diagnostics, which may be able to get their tests to patients without clearing the normal requirement for clinical performance evaluation data.
 
The Indian regulator wants organizations that receive approval for drugs, vaccines or diagnostics in other markets to contact it through the public relations office. Companies in that position may benefit from accelerated approval in India.
 
CDSCO is taking other steps to prevent its processes from slowing development. The agency plans to process applications to run COVID-19 drug and vaccine clinical trials within seven days and grant import licenses without registration certificates in case of emergency. Similar commitments apply to the diagnostic sector.
 
The publication of the fast-track notices coincided with the release of information about how CDSCO is adapting its routine operations to the pandemic. Shortly before the government put large parts of the country on lockdown, CDSCO told visitors to avoid large gatherings at its offices and follow good hygiene practices.
 
CDSCO Notice, More
 
Australia Passes Law to Accelerate Rollout of COVID-19 Diagnostic Tests
 
The Australian government has passed a law designed to accelerate the rollout of diagnostic tests for the SARS-CoV-2 coronavirus. Through the text, the government has exempted devices for use in the COVID-19 pandemic from parts of the therapeutic goods law that could restrict their availability.
 
Australia’s Therapeutic Goods Administration (TGA) framed the emergency exemption as a way to allow “COVID-19 diagnostic tests to be immediately supplied to accredited pathology laboratories” while it expedites “the regulatory assessment process for these kinds of medical devices.” The law in Australia already permitted accredited labs to develop their own diagnostics without requesting their inclusion in the Australian Register for Therapeutic Goods (ARTG).
 
TGA shared details of the exemption alongside an update on other aspects of the testing situation. The agency said it “is fielding a large number of enquiries from commercial suppliers of COVID-19 tests,” some of which have never previously sold diagnostics in Australia. TGA directed companies new to the Australian regulatory process to online resources.
 
The agency wants companies that know the process to file to get their tests added to the ARTG. TGA is expediting filings for all COVID-19 tests and may offer some diagnostics a particularly truncated path to market if advised to do so by other Australian medical authorities. The urgency of the situation has led TGA to propose waiving some premarket requirements, such as the need to gather stability data.
 
Australian Law, TGA Notice, More
 
New Zealand Warns of ‘Teething Problems’ as COVID-19 Forces Switch to Digital
 
The New Zealand Medicines and Medical Devices Safety Authority (Medsafe) has warned that users of a temporary regulatory system put in place in response to the COVID-19 pandemic are likely to face “teething problems.”
 
With restrictions imposed to curb the coronavirus pandemic affecting Medsafe and the companies it oversees, the regulator is rolling out a secure electronic file transfer system. The system is designed to enable regulatory personnel to send applications to Medsafe while they are working from home. As the system is new and temporary, Medsafe expects users to encounter some difficulties.
 
Exactly what teething problems users encounter will only become fully apparent as the system is rolled out, but Medsafe has already identified one potential sticking point. In disclosing the system, Medsafe warned users there may be “a delay between your request and being notified of successful registration.”
 
Medsafe shared details of the system alongside a message about other changes to its processes. The agency is deferring good manufacturing practice inspections or carrying them out remotely. Similarly, Medsafe has suspended audits under its Pharmacy Quality Audit Programme Framework “to help pharmacies maintain their work flow.” Medsafe will review the suspension on 1 July.
 
Medsafe Notice, More
 
Australia Limits Medicine Sales as COVID-19 Triggers Local Supply Shortages
 
Australia has imposed limits on the sales of medicines in response to a sharp increase in demand that caused some pharmacies and wholesalers to run out of stock. TGA thinks the shortages are local and temporary, but warned widespread disruption is possible as the COVID-19 outbreak escalates.
 
Working with the Department of Health, professional bodies have told pharmacists to only dispense a one-month supply of certain products at the prescribed dose and cap over-the-counter sales of some medicines at one unit per purchase. TGA highlighted prescription treatments for asthma and over-the-counter salbutamol inhalers as examples of the products subject to the restrictions.
 
Authorities are also “strongly” encouraging pharmacists to only dispense a one-month supply of all medicines. The product-by-product decision on whether to encourage or require pharmacists to cap sales was based on the consequences of supply disruption and likelihood of a drug being in increased demand during the COVID-19 outbreak.
 
Based on its talks with medicine manufacturers, TGA does not expect imminent or widespread national shortages. However, TGA warned that, “If current levels of demand through excessive purchasing continue, supply interruptions will occur at both the national level while sponsors await scheduled deliveries of new stock from international manufacturing sites and at the local level as a result of stockpiling by pharmacy customers.”
 
TGA issued its notice the day before its counterpart across the Tasman Sea, New Zealand’s Medsafe, put out a statement about drug supply. Medsafe used the notice to ask companies to tell it about anticipated supply disruptions as soon as they become aware of the risk.
 
TGA Notice, Medsafe Notice
 
Pakistan Plans Legal Action After Pfizer Complains About Fake Prevenar Vaccines
 
The Drug Regulatory Authority of Pakistan (DRAP) has outlined plans to take legal action in relation to the sale of unregistered, potentially counterfeit vials purporting to be Pfizer’s Prevenar. DRAP put forward the planned legal action after fielding a complaint from a Pakistani branch of Pfizer.
 
According to DRAP, Prevenar, the pneumococcal vaccine sold in the US as Prevnar, is only registered for distribution in Pakistan as a prefilled syringe. The version that triggered the complaint from Pfizer comes in vials. DRAP said the version sold in vials is “neither registered nor manufactured” by Pfizer’s Pakistani biologics group.
 
Faced with the situation, DRAP has written to multiple parts of Pakistan’s health and drug administration to request that “legal action may be initiated on the availability of unregistered/spurious Prevenar vaccine in vial.”
 
DRAP Notice
 
Other News:
 
Malaysia’s Medical Device Authority (MDA) has issued a notice about how restrictions imposed in response to COVID-19 are affecting its interactions with industry. MDA Notice