Roundups| 16 August 2022 | By
The Philippine Food and Drug Administration (FDA) seeks feedback on draft guidelines on the abridged regulatory review of clinical trial applications. In creating the text, FDA has drawn heavily on a draft released for consultation in May, while excluding rare diseases, cancer and HIV/AIDS from the list of eligible therapeutic areas.
The effort is based on FDA’s push to increase reliance on the work of other regulators. Last year, the World Health Organization released a document on good reliance practices that supported the use of the output of other regulatory agencies whenever possible. By leveraging the work of other agencies, regulatory bodies can focus their resources on in-country vigilance and other activities that cannot done externally.
The new draft provides guidelines on reliance for approval of clinical trial applications and promotes “a more efficient and effective approach to the regulations in the oversight of the conduct of clinical trials in the Philippines.” Specifically, the agency wants to “facilitate the evaluation of clinical trial applications addressing public health emergencies, and emerging and re-emerging infectious diseases of public health threats” and improve access to investigational drug products in such situations.
The new draft features extensive definitions of public health emergencies and emerging/re-emerging infectious diseases, as well as additional details about obtaining ethics approvals and what to file in relation to protocol amendments.
Under the guidelines, FDA can rely on information and relevant clinical decisions from a reference drug regulatory agency (RDRA) on the reliance-related studies for its own decision. The agency also can exempt a trial from a local good clinical practice inspection if an RDRA has conducted an inspection of the reliance-related study. FDA will assess the applicability of the RDRA review to the Philippines.
The abridged pathway is open to establishments with valid, FDA-issued licenses to operate that are running clinical trials of investigational products to address public health emergencies or emerging/re-emerging infectious diseases that threaten public health. All aspects of the filing, including the protocol and investigational product, must be identical to the submission assessed by the RDRA.
FDA is accepting feedback on the draft until 23 August.
Draft Guidelines
Singapore’s HSA updates advice on paclitaxel-coated devices
Singapore’s Health Sciences Authority (HSA) has updated its advice on paclitaxel-coated medical devices based on a systematic review and meta-analysis that found a higher risk of amputation in limbs treated with paclitaxel-coated balloons (PCBs).
The agency advises healthcare professionals to keep the paclitaxel dose to a minimum where possible and avoid repeat exposure to devices coated with the drug.
HSA also recommends that healthcare professionals “carefully weigh the clinical benefit and risks for each patient when considering the use of paclitaxel-coated balloons and stents” and continue surveillance of patients with peripheral artery disease treated with paclitaxel-coated devices, building on the advice it provided in 2019 after the risks first became known.
HSA Notice
Australian firm ordered to pay $56,000 after failing to settle unlawful importation fine
The Federal Court of Australia has ordered Enviro Tech Holdings to pay AU$80,000 ($56,000) for unlawful importation of surgical face masks. The action follows the failure of the company to pay the AU$13,320 infringement notice it received in December 2020.
Australia’s Therapeutic Goods Administration (TGA) issued the infringement notice over the alleged importation of 500,000 single-use surgical face masks and gave Enviro Tech around one month to pay the fine. TGA deemed the imports to have contravened the condition of a pandemic exemption to the rules on bringing face masks into the country.
The Federal Court found that the company’s actions were based on “the inexperience of the respondents rather than a deliberate attempt to circumvent the requirements of the exemption.” While the maximum penalty for the company was AU$11.1 million, the court set the fine at AU$80,000 and told two company officers to pay AU$8,000 each.
TGA disclosed news of the court action on the same day as it issued five infringement notices totaling AU$66,600 to 2San for allegedly failing to provide information to demonstrate the ongoing minimum level of sensitivity of two COVID-19 rapid antigen tests.
TGA Notice, More
India’s NPPA to take web portals offline to upgrade pharma database
India’s National Pharmaceutical Pricing Authority (NPPA) will take its web portals offline from the 17 to 28 of August to upgrade the system. The action affects Pharma Jan Samadhan, part of the government’s Digital India initiative, and the Integrated Pharmaceutical Database Management System (IPDMS).
While the services are offline, NPPA will upgrade the IPDMS portal, which the authority created to enable companies to comply with the mandatory reporting requirements set out in the Drugs (Prices Control) Order, 2013. The authority pushed last year to increase use of the platform after seeing low uptake of a system intended to gather data to support evidence-based decisions.
In the interim, NPPA will accept complaints about the overpricing, nonavailability and shortage of drugs, sales without price approval and the refusal to supply medicines via email.
NPPA Notice
Malaysia’s MDA cracks down on social media platforms over medical device posts
Malaysia’s Medical Device Authority (MDA) has targeted Facebook, Instagram and TikTok as part of a crackdown on illegal trade in medical devices. MDA found 792 links that violated the Medical Device Act 2012.
As part of the global Operation Pangea, MDA targeted medical face masks, medical gloves, oximeters, thermometers, COVID-19 test kits, glucometers, contact lenses and blood pressure devices on the three social media platforms and five e-commerce sites.
MDA also seized some medical devices, including 2,400 COVID-19 test kits, 428 units of medical gloves and 207 packs of bandages, and conducted 130 inspections of pharmacies and other retailers. The inspections identified 79 medical devices sold at 42 premises that violated the registration requirements.
MDA Notice (Malay)
Other news:
China has included a domestically developed COVID-19 antiviral in its diagnosis and treatment guidelines. The National Medical Products Administration (NMPA) granted emergency use authorization to the drug, Genuine Biotech’s Azvudine, late last month, leading to its addition to the guidelines one week ago. NMPA Notice
India’s Department of Pharmaceuticals (DoP) has published details of the domestic manufacturers of critical key starting materials, drug intermediates and active pharmaceutical ingredients that will receive support under the Production Linked Incentive Scheme. DoP Notice
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