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Regulatory Focus™ > News Articles > 2020 > 8 > Asia-Pacific Roundup: Philippine FDA scales back as COVID cases spike

Asia-Pacific Roundup: Philippine FDA scales back as COVID cases spike

Posted 25 August 2020 | By Nick Paul Taylor 

Asia-Pacific Roundup: Philippine FDA scales back as COVID cases spike

An “alarming” rise in new cases of COVID-19 has led the Philippine Food and Drug Administration (FDA) to  ban face-to-face interactions with customers and set up drop boxes for depositing documents to help curb the spread of the virus in the country.
 
The rolling seven-day average of new COVID-19 cases in the Philippines passed 4,000 on 5 August, up dramatically from an average of less than 2,000 per day a week earlier. The surge led the Philippine government to reimpose lockdown restrictions on more than 27 million people who live in and around the capital city Manila. Since then, the rapid rise in cases has stopped but the Philippines continues to average more than 4,000 new cases a day.
 
Against that backdrop, the Philippine FDA has moved its operation online. FDA staff generally will not interact face to face with clients at the Food and Drug Action Center, although some employees will work at “frontline counters” while wearing masks and visors. Organizations that need to share physical documents may use drop boxes at the main entrance, FDA said.
 
FDA will share details of approvals via email or the e-portal and use couriers to send hard copies. Applications for sales promotion permits will also be dealt with via courier. Those changes, like others imposed by FDA, will stay in place until further notice.
 
In a separate document, FDA updated its guidance on applications and transactions. The document extends some of the provisions that FDA put in place in response to the coronavirus in March. Under the latest document, FDA will extend all licenses to operate that expire between now and the end of the year by four months.
 
FDA Notice, Operational Guidelines
 
TGA explains the basis for infringement notices, how it calculates fines
 
Australia’s Therapeutic Goods Administration (TGA) generally will use infringement notices “in matters where there is a reasonable prospect that they will achieve compliance quickly” since court actions, another enforcement option, take longer and therefore “may not be the most suitable means of securing compliance promptly,” according to new guidance from the agency.
 
TGA issued infringement notices toting up to AU$549,000 ($395,000) in fines related to COVID-19 by the end of June and continued to take enforcement actions in the weeks thereafter. Many of the fines were driven by what an independent review of TGA called a “hardline approach” to the enforcement of rules on the promotion of products in relation to COVID-19. (RELATED: COVID-19 drives hard-line advertising enforcement at TGA, Regulatory Focus 11 August 2020.)
 
The new guide explains that TGA can issue infringement notices in relation to breaches of its requirements on imports, exports, manufacturing, supply and advertising. Failure to respond to TGA requests and the provision of false or misleading information also can trigger infringement notices.
 
Accompanying fines are based on a formula that charges people and corporations that breach the rules AU$222 per “penalty unit.” The maximum penalty for people is lower than that for corporations. TGA can issue an infringement notice for each breach.
 
Fined parties can either pay the fine in full by the specified date, request an extension, formally seek the withdrawal of the notice or refuse to pay and risk being taken to court. TGA said it “usually” starts court proceedings for non-payment.
 
TGA Notice
 
China’s CDE shares draft guidance on cell therapy clinical trials
 
China’s Center for Drug Evaluation (CDE) has shared draft guidance on clinical development of cell therapies. The guidance covers information including the criteria companies need to fulfill to file for approval of cell therapies in China.
 
Details addressed in the section on the conditions for drug registration cover the consistency and quality of the cell therapy and the integrity of the clinical research data. Elsewhere in the guidance, CDE discusses how to design exploratory and confirmatory clinical trials and the need for long-term follow-up of study subjects.
 
CDE is accepting feedback on the draft for one month.
 
CDE Notice (Chinese)
 
TGA adds auto-population of details to online clinical trial notification form
 
TGA has made enhancements to its online clinical trial notification (CTN) form. The enhancements include the auto-population of the contact details originally entered on the user’s Electronic Business Services account.
 
In an update to its CTN user guide, TGA said the auto-population feature adds the name, email and phone number of the person nominated to receive correspondence from the agency. The changes are part of a wider, ongoing effort to improve the online form for communicating details of clinical trials to TGA.
 
TGA also updated the submission process as part of its revision to the user guide, the first version of which took effect late in 2017.
 
User Guide
 
Pakistan’s DRAP defers decision on Sanofi to drug to enable further evaluation
 
The Drug Regulatory Authority of Pakistan (DRAP) has deferred its decision about an application from Sanofi for Depura Plus to enable “further evaluation and clarification.”
 
Depura Plus, a treatment for vitamin D deficiency, was up for review at the Enlistment Evaluation Committee in June. However, the application was one of more than 1,300 deferred by the committee due to deficiencies in the information or documents provided. DRAP has given applicants until 7 September to address the deficiencies.
 
DRAP Document
 
Other News:
 
India’s National Pharmaceutical Pricing Authority (NPPA) is seeking support from organizations that can provide it with data on sales of medicines in the country. The tender notice calls for bids from organizations that can provide reports on scheduled and non-scheduled price violations, as well as a breakdown of monthly sales of medicines in India. NPPA Tender
 
TGA has issued a safety advisory about hydrochlorothiazide, a diuretic used to treat high blood pressure that Phebra sells in Australia under the brand name Dithiazide. The advisory details a risk of non-melanoma skin cancer linked to the molecule. The US Food and Drug Administration issued a similar notice on the same day as TGA. TGA Advisory
 

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