Asia Regulatory Roundup: CDSCO rapid response framework for COVID-19 vaccines

RoundupsRoundups | 02 June 2020 |  By 

As part of its rapid response regulatory framework for handling COVID-19 vaccines, the Central Drugs Standard Control Organization (CDSCO) of India says that it is open to considering data generated outside of the country and to otherwise truncating development to cut the time it takes to access a vaccine.
With R&D groups in the US, China and UK leading efforts to bring a COVID-19 vaccine to market, CDSCO is willing to consider regulatory submissions featuring data from preclinical tests done outside of India. CDSCO will assess the quality of the submitted foreign data and potentially ask the applicant to run a “limited preclinical study.”
Similar rules apply to clinical data generated overseas. CDSCO will review the scientific rationale and “completeness” of clinical data on a vaccine before deciding on whether to permit foreign evidence to support the progress of a vaccine candidate in India.
Sponsors that file to test COVID-19 vaccines in India should benefit from the framework. CDSCO will accept parallel applications covering certain aspects of development to cut the risk that paperwork will slow the progress of vaccines against the SARS-CoV-2 coronavirus.
The rapid response framework also contains a checklist for companies that want to run preclinical toxicity studies of COVID-19 vaccines. The checklist addresses activities including molecular characterization, the standardization of production processes and the assessment of the immune response triggered by the vaccine. It also provides details of exactly what it will take to meet the CDSCO’s requirements. For example, to satisfy CDSCO’s request for real-time stability information applicants will need to have one month of data at the time of the submission. Applicants also need to commit to continuing to gather real-time data and filing the complete dataset at the time of the toxicity report.
Regulatory Framework
India lifts restrictions on paracetamol API exports
India’s Directorate General of Foreign Trade (DGFT) has lifted restrictions it imposed on paracetamol active pharmaceutical ingredients (APIs) in March. The action continues the staggered loosening of limits on exports of APIs and finished products that India imposed early in the coronavirus crisis.
As the coronavirus crisis escalated In the first week of March, DGFT applied a “restricted” export policy to more than 20 APIs and finished products. The action limited exports of certain ingredients and products to ensure that India, a major global supplier of APIs and generic medicines, retained enough supplies to serve its own population at a time of considerable disruption and uncertainty.
Since then, DGFT has gradually reversed the restrictions, with most lifted by early April. The government trade body began permitting unrestricted exports of paracetamol finished products later that month but kept the limits on paracetamol APIs in place. 
Restrictions on the exportation of some face masks and diagnostic kits remain in place.
DGFT Notice
Philippine FDA creates guidelines on PPE, ventilators and respirators
The Philippine Food and Drug Administration (FDA) has published interim guidance on manufacturing and importing personal protective equipment (PPE), ventilators and respirators for use in response to the COVID-19 outbreak.
The agency responded early in the pandemic by enacting policies intended to ensure the availability of products needed to stop the spread of the coronavirus and treat COVID-19 patients. The policies relaxed the requirements for importing and manufacturing certain medical devices for use in the Philippines.
Last week, FDA repealed those earlier policies. In explaining its action, FDA said “there is now adequate supply of medical devices used for the COVID-19 pandemic [but] concerns regarding safety and quality of these products have grown.”
The new interim guidelines reflect the changing thinking about the possible trade-off between speed and quality in the Philippines. FDA is still allowing companies to start making or importing ventilators, respirators and PPE after obtaining a license to operate (LTO). However, the agency is now advising companies to also apply for a Certificate of Product Notification (CPN) before shipping devices.
Adding a CPN to the list of documents companies should have prior to beginning commercial supply could raise standards. Association of Southeast Asian Nations guidelines on harmonized technical requirements for medical devices apply to CPN applications, whereas the LTO process is only subject to FDA’s unified licensing rules. 
FDA wants companies that began selling products under its more relaxed, now-repealed policies to apply for a Certificate of Medical Device Notification or Certificate of Product Registration within three months. The agency also expects “strict” postmarket surveillance to be implemented and warned that failure to comply with the requirements will lead to “proper regulatory action.”
While strengthening the rules on local manufacturers, FDA has retained its existing position on the importation of PPE, ventilators and respirators. As such, commercial importers will need to present a LTO and no clearance will be required for foreign donations of devices for use by the employees of a company.
Interim Guidelines
TGA starts legal proceedings after company fails to act on advertising order
Australia’s Therapeutic Goods Administration (TGA) has taken a company to court after it failed to remove advertising the agency deemed unlawful. The initiation of legal proceedings comes weeks after TGA fined the company, MMS Australia, AU$151,200 ($101,700).
TGA alleges that MMS Australia made claims about the role its Miracle Mineral Solution can play in the treatment, prevention or alleviation of disease, including COVID-19. As part of the action, TGA asked MMS Australia to immediately remove all adverts that were in breach of the rules.
MMS Australia failed to move fast enough, leading the agency to start legal proceedings. TGA has asked the court to make MMS Australia update its website with a notice “that consists of at least 50% of the screen area” about the court case. 
Today, visitors to the MMS Australia website need to register and login. All the information was available to unregistered users as recently as 19 April, according to an old version of the site stored by Internet Archive. Since then, MMS Australia has shared an update with logged-in users about the “current media lies that our site promotes the drinking of dangerous industrial bleach, and the attendant, if ignorant and reprehensible, harassment and attacks on our Church.”
TGA shared details of its legal case against MMS Australia the day after its regulatory counterpart in New Zealand published a warning about Miracle Mineral Solution. The New Zealand Medicines and Medical Devices Safety Authority (Medsafe) said the products contain a high concentration of sodium chlorite, a substance used in textile bleaching, that when mixed as directed turns into a bleach “that can cause dangerous and potentially life-threatening side effects when consumed.”
Medsafe, like TGA, has previously issued a warning about the safety of the products. The agency felt it necessary to reiterate its warning after a recent uptick in queries about the products.
TGA Notice, Medsafe Statement


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