Asia Regulatory Roundup: TGA Partly Suspends Overseas Inspections in Response to COVID-19 Outbreak

RoundupsRoundups | 17 March 2020 |  By 

Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia.
TGA Partly Suspends Overseas Inspections in Response to COVID-19 Outbreak
Australia’s Therapeutic Goods Administration (TGA) has suspended inspections of manufacturers in some countries in response to a travel ban imposed in the country. TGA also warned that restrictions on the travel of inspectors at other regulatory agencies may hinder its ability to perform desk-based assessments of overseas manufacturers.
On 12 March, Australia began requiring citizens and permanent residents who had visited mainland China, Iran, the Republic of Korea or Italy to self-isolate for 14 days. At the same time, the Australian government banned foreign nationals from entering the country in the 14 days after they left any of the countries targeted by the travel restrictions. On 15 March, Australia went a step further, requiring all travelers to the country to self-isolate for 14 days.
In between the two notices, TGA set out how the travel restrictions are affecting its operations. TGA has suspended good manufacturing practice (GMP) inspections of plants in “some countries” in light of the government’s advice. The agency will notify companies if they are affected by the suspension.
TGA’s reliance on regulators in other regions for materials means it is also affected by travel bans put in place by other governments. Through the GMP clearance program, TGA performs desktop reviews of overseas manufacturing facilities. As those reviews make use of the findings of other agencies, the GMP clearance program could be disrupted. The United States Food and Drug Administration, one of the agencies that TGA relies on, has stopped most foreign inspections.
In light of the potential disruption, TGA reminded companies “of their responsibilities to maintain the validity of their GMP Clearances for overseas manufacturers and, where there is an impact due to the COVID-19 outbreak that results in delays to GMP inspections, to submit extension application(s) as outlined in the GMP Clearance Guidance.” 
TGA Notice
India Addresses Multiple Concerns Related to new Drugs and Clinical Trial Rules
India’s Central Drugs Standard Control Organization (CDSCO) has issued a series of notices addressing concerns and uncertainties about the New Drugs and Clinical Trial Rules, 2019.
In one of the notices, CDSCO responded to concerns about a requirement for new drugs to be tested at central government laboratories before approval. The concern centered on how the requirement applies to new drugs that are pharmacopoeial products or a different strength of a medicine that is on the market already.
CDSCO responded to the concerns by establishing timelines for testing at government laboratories. For new drugs, the timeline is four weeks. The timeline extends to six weeks for pharmacopoeial new drugs and to eight weeks for “other new drugs.” CDSCO thinks the timelines will “streamline” the new drug approval process.
The Indian regulator shared details of the timelines on the same day as it posted three other notices about the New Drugs and Clinical Trial Rules. One of the notices clarified the rules on submitting data on chemistry, manufacturing and controls. The other two notices addressed when process validation is needed and the approval of drugs that are now manufactured synthetically but were previously approved as recombinant DNA-derived products.
Laboratory Testing, CMC Requirements, Process Validation, Synthetic Drugs
Lockdown of Manila Forces Philippine FDA to Function With Skeleton Staff
The Philippine Food and Drug Administration (FDA) will be operating with a skeleton staff for the next month after the government locked down the city of Manila. FDA is adopting “alternative work arrangements” to manage the disruption caused by the coronavirus outbreak.
Manila is set to be on lockdown from 15 March to 14 April. FDA put its response in place on 16 March. From then until further notice, FDA will limit access to its ePortal system to 7 a.m. to 7 p.m. on weekdays. FDA is “strongly” advising all stakeholders “to process all electronic applications during the said time.”
The coronavirus outbreak has also disrupted FDA’s international activities. FDA has postponed all foreign inspections scheduled for March and April, effective immediately. Other agencies, including the FDA’s US counterpart, have taken similar actions.
FDA is trying to deal with the disruption at the same time as handling additional work created by the outbreak. In a series of notices published over the past week, FDA articulated the situation regarding the availability of coronavirus tests in the Philippines. At the time of FDA’s notices, there were no registered COVID-19 tests available in the country.
With neither local nor multinational groups making tests available to supplement the capacity of the Research Institute for Tropical Medicine, FDA warned the public about risks posed by unauthorized diagnostics. FDA also imposed a price cap on masks and other devices used to control and treat the virus.
FDA Notice, More
China’s NMPA Outlines Plans to Randomly Inspect Medical Device Operations
China’s National Medical Products Administration (NMPA) has set out its position on the inspection of medical device operations. NMPA plans to conduct random inspections as part of its efforts to ensure the quality of medical devices sold in China.
The document calls for national and regional regulators to formulate an annual inspection plan in the first quarter of each year. NMPA wants the national and regional plans to complement, not duplicate, each other. That objective will be supported by differences in the priorities that NMPA established to shape the creation of the inspection plans.
Other sections of the document describe topics including the experience regulatory officials involved in the work should have and the consequences of noncompliance. Manufacturers may need to pull devices from the market, perform in-depth self-assessment and adopt risk-control measures. NMPA expects companies to keep risk-control measures in place while applying for re-inspection.
The document also puts responsibilities and restrictions on regulatory officials involved in the work. Specifically, NMPA is prohibiting staff from releasing inspection information without authorization and from accepting gifts from the companies they oversee.
NMPA Notice (Chinese)
Malaysia’s MDA Posts Draft Guidance on IVD Classification for Consultation
Malaysia’s Medical Device Authority (MDA) has released two draft documents on the classification and grouping of in vitro diagnostics (IVDs) for consultation.
One of the documents sets out MDA’s approach to the classification of IVDs. MDA has based the text on the work of the Global Harmonization Task Force, a precursor to the International Medical Device Regulators Forum. The resulting system divides IVDs into four categories based on the risk they pose to individuals and the public.
MDA released the draft guidance alongside a separate document describing how medical devices can be grouped into one of five categories for the purposes of registration and listing in the Malaysia Medical Device Register.
The document describes the five groups, stating, for example, that products are treated as “single” devices if they are “sold as a distinct packaged entity.” MDA lists standalone software for a blood-screening assay as an example of a device that would be put in the single group.
MDA is accepting feedback on the draft documents until 27 March.
MDA Guidance, More
Other News:
TGA is set to expand the number of quality audits it performs on medicinal cannabis products. The plan follows growth in the number of medicinal cannabis special access scheme applications sent to TGA. Manufacturers of products imported under the scheme do not undergo good manufacturing practice inspections but must comply with applicable standards. TGA Notice


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