Asia Regulatory Roundup: India acts to stop hoarding of N95 masks, prevent gouging

RoundupsRoundups | 26 May 2020 |  By 

The Indian government has ordered companies involved in the supply of N95 face masks to keep the cost of their products down. Officials issued the notice in response to reports of N95 face mask “hoarding, black-marketing and differential higher pricing.”
N95 face masks are classed as an essential commodity under an action the India government took in mid-March. The legislation makes hoarding and black-marketing a punishable offense. Officials have also directed regional governments to ensure that masks, hand sanitizer and gloves are not priced at above the maximum retail price as of 13 March.
The government is buying the “largest chunk” of N95 masks from manufacturers and importers “at bulk rates and ex-factory prices,” it said in a statement last week.
Other purchasers are paying “differential prices” for N95 masks which could limit the availability of affordable personal protective equipment, according to the government. Therefore, the National Pharmaceutical Pricing Authority has asked manufacturers, importers and suppliers of N95 face masks to “maintain parity in prices for non-governmental procurements and to make available the same at reasonable prices.”
Instances of hoarding, black-marketing and prices rises “will be viewed seriously,” as the government plans to use its powers to punish profiteers under legislation that permits fines and prison terms of up to seven years.  
Government Statement
Philippines issues guidance on clinical trials and licensing requirements
New guidelines on the regulation of clinical trials and a simplified approach to licensing applications are part of a broader push to make it easier to do business in the Philippines.
The government aims to ensure sponsors follow good clinical practices and, in doing so, protect the rights and safety of study subjects. Other objectives include ensuring efficient approval of clinical trials, providing standards for investigational products and enhancing oversight of studies through inspections. The guidance was issued via an administrative order on clinical trials shared last week by the Philippine Food and Drug Administration (FDA).
The guidance applies to sponsors, contract research organizations, investigators and research ethics committees involved in clinical trials designed to help bring investigational products to market. The rules also apply to products that are seeking an additional indication, dose, route of administration or  patient population.
Companies that fall within the scoop of the guidelines will need to meet timelines set out in the text. The guidelines give companies 30 calendar days after receiving clearance to start a study to upload information to the clinical trial registry. In the event of a fatal or life-threating unexpected adverse reaction, the sponsor has seven calendar days to alert FDA. Sponsors have a further eight calendar days to share a complete report detailing the importance and implications of the event.
The document also imposes timelines on FDA, which will need to decide whether to permit a clinical trial within 60 calendar days of receiving an application. Inspection findings must be shared within 45 calendar days.
FDA shared the clinical trial guidance the day after alerting the industry to an administrative order about unified licensing requirements and procedures. The government issued the licensing order to simplify how licenses are obtained, renewed and revised, and to streamline and automate systems used by FDA.
To seek a license, applicants need to complete an online form, provide proof of income and business name registration, and pay fees. The guidance gives FDA six months to create a fully automated online application system for receiving and processing requests for licenses to operate. FDA began an eServices portal pilot project earlier this month. The pilot is open to groups including drug distributors that need to make initial licensing applications or amend existing clearances
Trial Guidance, Licensing Requirements, Pilot Project
China’s CDE starts phased resumption of on-site regulatory services
The Center for Drug Evaluation (CDE) has begun the phased resumption of on-site regulatory services as China begins to lift measures implemented to control the spread of SARS-CoV-2.
On Friday, China said it recorded no new cases of COVID-19 for the first time since the start of the outbreak. Hours before news of that milestone emerged, CDE issued a statement about plans to start resuming in-person activities beginning on 25 May. The CDE plan calls for the gradual resumption of activities.
In the first phase of the plan, CDE will resume on-site declarations and signings at its offices. People will need to book an appointment online to use the in-person service and submit a registration form the day before their visit.
CDE expects people who visit its offices to wear masks, present their health code — a digital system that indicates an individual’s health status — and stay one meter away from other people. The agency also will perform body temperature checks. CDE is discouraging gathering and wants people to quickly complete their business and then leave.
Some on-site service will not yet resume. Some documents will continue to be handled by mail and anyone who cannot comply with the rules on in-person interactions should continue to conduct business remotely. 
CDE Notice (Chinese)
TGA establishes requirements for the reprocessing of N95 masks
Amid concerns about the availability of N95 masks, some Australian healthcare facilities have established strategies for decontaminating and reusing personal protective equipment. To support those efforts, the Therapeutic Goods Administration (TGA) is working with “a small number” of sponsors of technologies designed for use in the decontamination of medical devices.
TGA has published a list of requirements that decontamination systems developers will need to meet before their technologies are used. TGA wants companies to show data on inactivation of microorganisms “under worst case conditions” and provide evidence that residues left on masks after reprocessing “are insignificant and unlikely to cause a health hazard.”
Developers also must create instructions for healthcare facilities and workers on how to inspect reprocessed face masks for signs that they are faulty, visibly damaged or fit poorly.
TGA Notice
Other News:
TGA has issued more fines over the advertising of products in relation to COVID-19. The agency fined a doctor AU$37,800 ($24,900) over online adverts for products not included in the Australian Register of Therapeutic Goods. Separately, TGA fined NutriPATH AU$12,600 regarding the promotion of a COVID-19 test collection kit. TGA Notice, More
China’s CDE is seeking feedback on guidance about single-arm clinical trials of cancer drugs other than cell and gene therapies. The guidance comes weeks after CDE shared guidance on the use of imaging endpoints in cancer trials. CDE is accepting feedback on the draft for one month. CDE Notice (Chinese)


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