Asia-Pacific Regulatory Roundup: COVID-19 drives hard-line advertising enforcement at TGA

Australia’s Therapeutic Goods Administration (TGA) has taken a hard-line approach to enforcing the rules on the advertising products to prevent, treat and diagnose COVID-19, according to an independent review commissioned by the agency.
 
The independent review was designed to assess the impact of advertising oversight triggered by the 2015 Expert Panel Review of Medicines and Medical Devices Regulation. Because it occurred during the first six months of 2020, it also focused on the agency’s approach to claims about products in relation to the COVID-19 pandemic.
 
“Departmental staff indicated that there had been an internal shift in attitude, towards much more hard-line enforcement in response to the more serious risk atmosphere presented by misleading advertising around COVID-19 claims,” the review authors wrote.
 
The findings are in line with actions taken by the agency in recent months. TGA has issued a series of fines to companies alleged to have broken the rules on the promotion of COVID-19 products, for a total of AU$549,000 ($394,000) in COVID-19-related fines by the end of June.  
 
TGA also has stepped its use of public notices, mainly to make consumers aware of the illegal advertising of COVID-19 products. The uptick in fines and public notices are part of “an increase in the timely use of stronger enforcement responses,” according to the review.
 
The review calls on TGA to “reflect on the lessons learned” during the coronavirus outbreak in relation to the timely punishment of noncompliant advertising. The authors opted against making explicit recommendations, choosing instead to say the pandemic “has useful learnings regarding the use of media and publicising the compliance actions taken by the TGA to raise awareness of the negative consequences of using noncompliant advertising.”
 
The comment about COVID-19 formed part of one of 22 recommendations from the review authors, who also recommended the Australian government maintains TGA as the sole body responsible for implementing a complaints management process.
 
Other recommendations call for TGA to “reset the complaints management system to focus on achieving improved compliance outcomes through intelligence gathering, strategic triaging and integrated response” and to integrate the management of complaints with other areas of its operation.
 
The authors also recommended that TGA develops “a clear regulatory position on its approach to the use of the broadened sanctions and penalties to protect public health and safety” and redevelops “a suite of advertising compliance performance measures and indicators which focus on priorities and outcomes rather than processes and deadlines.”
 
The government has accepted all 22 recommendations. TGA plans to make many of the called-for changes this year.
 
Independent Report, TGA Statement, More
 
India lifts all pandemic-related restrictions on ventilator exports
 
India’s Directorate General of Foreign Trade (DGFT) has ended the prohibition on ventilator exports imposed in March, following reduced concerns that the COVID-19 pandemic could cause a shortage.
 
Governments around the world scrambled to source ventilators early in the pandemic as the use of the devices to treat COVID-19 patients with acute respiratory distress syndrome led expert observers to predict demand would outstrip supply. The capacity concerns abated as countries stepped up local production and evidence emerged that ventilators make some patients worse.
 
DGFT has changed its ventilator export policy in line with changing perceptions about the likelihood of hospitals running out of devices. In March, DGFT prohibited the export of all ventilators, including all artificial respiratory and oxygen therapy apparatus. This week, DGFT completely lifted the ban.
 
The total U-turn differs from the approach DGFT has taken to other products used in the response to the coronavirus pandemic. For example, DGFT has begun to allow the export of limited quantities of certain types of personal protective equipment, having previously stopped all such products from leaving the country. DGFT has opted against taking such an interim step in the relaxation of its rules on the export of ventilators.
 
DGFT Notice
 
India creates pathway for the licensing of more rational FDCs
 
India’s Central Drugs Standard Control Organization (CDSCO) has created a pathway for the licensing of fixed-dose combinations (FDCs) that feature vitamins, minerals and micronutrients. The pathway is designed to help manufacturers of 471 FDCs deemed by the Kokate Committee to contain rational combinations of ingredients.
 
In the years since it gave FDC manufacturers 18 months to demonstrate the safety and efficacy of their products, CDSCO has established regulatory processes to enable companies to get licenses for drug combinations that originally came to market without going through the usual channels. CDSCO created one such licensing pathway in 2017 and established another process for companies that lack data to support seemingly rational FDCs last year.
 
Now, CDSCO has set up a new pathway for FDCs that contain vitamins, minerals and micronutrients. Manufacturers of the 471 rational FDCs containing such ingredients must pay CDSCO a fee for each product and seek manufacturing licenses from the relevant state licensing authority (SLA). Provided the conditions are met, the SLA will grant licenses without seeking a no-objection certificate from the national regulator. SLAs are only to award licenses for the 471 FDCs set out in CDSCO’s list.
 
CDSCO expects manufacturers that receive licenses via the pathway to submit periodic safety update reports in compliance with the New Drugs and Clinical Trial Rules, 2019. Manufacturers that fail to file the reports will be considered to have contravened the rules.
 
CDSCO Notice
 
Philippine FDA seeks feedback on updated Citizen’s Charter texts
 
The Philippine Food and Drug Administration has released an updated version of its Citizen’s Charter for comment. The document covers details of many regulatory services provided by FDA.
 
This year, FDA has published five separate Citizen’s Charter documents covering processes related to different parts of its operation. For example, the Center For Drug Regulation And Research document describes the processes for obtaining a license to operate or a certificate of product registration, as well as the inspection agendas for different types of organization regulated by FDA.
 
Much of the information is contained in the 2019 version of the Citizen’s Charter. The version shared for consultation this week is the first iteration of the 2020 edition of the charter. 
 
FDA is accepting feedback on the drafts until 18 August.
 
FDA Notice
 
Other News:
 
China’s Center for Drug Evaluation (CDE) has published guidance on the requirements for drugs produced overseas. The document details a shift in CDE’s approach. CDE Notice (Chinese)