Asia Regulatory Roundup: COVID-19 drives Australia to propose delay to medical device reforms

RoundupsRoundups | 23 June 2020 |  By 

Australian medical device reforms could be delayed until next year to give the industry more time to prepare, considering the effect COVID-19 has had on preparations.
Under the current timeline, Australia would implement a raft of reforms to its medical device rules on 25 August. If enacted, the delay will push the implementation of reforms to the regulation of medical device software and personalized medical devices back to 25 February 2021. The government is also proposing to hold off on implementing reforms to procedure packs and the reclassification of certain devices until 25 November 2021.
The planned delay to reclassification will affect manufacturers of a range of medical devices. Spinal and active implants, inhaled drug delivery devices and products that come into direct contact with the heart, central circulatory system or central nervous system are all up for reclassification.
The Therapeutic Goods Administration (TGA) looked to the European Medical Device Regulations (EU MDR) to inform its reclassification process. With the European Union delaying the date of application of EU MDR 12 months, Australia may also push back changes to its medical device essential principles.
The plan is to delay the Essential Principles in the Australian Medical Device Regulations for up to two years after the start of EU MDR. If that happens, the essential principles will take effect in 2023. The same delay will apply to essential principles on in vitro diagnostics, pushing the implementation of those changes out to 2024.
TGA said the delays would “provide time for industry to adjust to the EU regulations and to allow consideration of similar changes in the Australian context and ensure that the transition in Australia is implemented effectively.”
TGA Notice
Japan tightens takeover rules to maintain science base during the pandemic
Japan has tightened the rules covering acquisitions of stakes in manufacturers involved in infectious disease interventions and “specifically controlled medical devices” in response to the pandemic.
Last month, Japan enacted legislation to strictly regulate foreign investment in businesses operating in 12 core sectors. Investors in companies in the sectors, which include cybersecurity and oil, need to notify the government before buying 1% or more of the listed shares of a business. The threshold for non-core businesses is 10%.
Work on the legislation predates COVID-19 and the medical product sector was absent from the list of 12 core industries. That changed this week when the Japanese Ministry of Economy, Trade and Industry (METI) added medical sectors to the list.
The restrictions on foreign investment will apply to more than just the companies that make finished products, but also to manufacturers of intermediates used in the production of infectious disease products, and on companies that make accessories and parts for certain medical devices.
METI’s actions are part of a global revaluation of the value of domestic scientific capabilities sparked by COVID-19. The UK cited its lack of a major domestic diagnostic industry as a reason it failed to scale up testing capacity as quickly as its peers, while Germany took a €300 million ($337 million) stake in CureVac in the wake of reported interest from the US government in the vaccine developer.
METI Notice
CDSCO clears Cipla and Hetero to make remdesivir for the Indian market
The Central Drugs Standard Control Organization (CDSCO) has authorized Cipla and Hetero Drugs to manufacture and market Gilead Sciences’ COVID-19 antiviral remdesivir for use in India.
CDSCO approved remdesivir for import and marketing in India at the start of June. However, this week the Drug Controller Director General of India VG Somani said “the importer is yet to import the drug after taking import licence from CDSCO.” Granting restricted emergency use to Cipla and Hetero will enable Indian COVID-19 patients to access remdesivir regardless of the import situation.
Under the authorizations, Cipla and Hetero can “manufacture and market the same injectable formulations of the drug to the indigenous manufacturers for the same indication, restriction and conditions for use as stipulated for innovator’s product.” Somani thinks the authorization will give severe COVID-19 patients in India early access to remdesivir.
Gilead set the stage for the authorizations last month when it entered into licensing agreements with Cipla and Hetero. The agreement with Hetero cleared the it to distribute remdesivir in 127 countries.  
Somani disclosed news of the remdesivir authorizations alongside details of a decision about another antiviral, favipiravir. CDSCO has authorized Glenmark Pharmaceuticals to market favipiravir tablets for use in patients with mild to moderate cases of COVID-19. Favipiravir is a Fujifilm drug originally used to treat influenza in Japan.
CDSCO Notice
TGA creates guidance on transitioning to new GMP requirements
TGA has released a transition plan to help companies adapt to good manufacturing practice (GMP) requirements set out in the updated PIC/S guide.
Last month, TGA outlined plans to adopt the guide on 1 July 2020, two years after it was released by PCI/S. TGA built a 12-month “graduated transition period” into the plan to give manufacturers time to assess new supplementary requirements and make the changes necessary to ensure compliance with the rules.
This week, TGA shared more details of the transition. TGA expects manufacturers to have completed assessments of the impact of the guide and be “well advanced” toward making the required changes by the start of next year.
Companies should have started updating quality systems documentation and working to implement revised working practices by the end of the year. TGA expects companies to spend the first half of next year finishing off that work, running staff awareness training programs, amending contracts and commencing trending critical parameters. 
The TGA guide also features detailed breakdowns of the ideal timing of activities related to specific requirements, such as the new rules on starting material controls and medicine shortages.
TGA Guidance
Malaysia’s NPRA updates guidance on product registration for APIs
Malaysia’s National Pharmaceutical Regulatory Agency (NPRA) has updated its guidance on active pharmaceutical ingredients (API). The guidance features a new section on referencing drug master files (DMFs) previously submitted to NPRA.
In the new section, NPRA advises DMF holders to submit a complete DMF electronically and a letter of access authorizing the agency and local product registration holder to reference the resource. The letter should include a declaration that the DMF holder will tell NPRA and the registration holder of changes to the API specifications or manufacturing process that are likely to affect quality or safety.
The DMF holder should also send a copy of the letter and the open part of the DMF to the product registration holder. When the registration holder files an application referencing the DMF, NPRA will review the complete resource submitted by the DMF holder before making a decision.
NRPA published the new section as part of an update that also added four more ingredients to the list of atypical APIs. In addition, NPRA used the update to let API manufacturers know they can send DMFs “via secured online data transfer” during the COVID-19 pandemic. 
NPRA Guidance


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