Asia-Pacific Roundup: TGA updates timeframe for prescription medicines registration process

RoundupsRoundups | 17 August 2021 |  By 

Australia’s Therapeutic Goods Administration (TGA) has updated the timeframe for the expert advisory review phase of the prescription medicines registration process. TGA is now aiming to send advice to the applicant 10 to 12 working days after the meeting.
The Australian registration process includes the option for the Advisory Committee on Medicines (ACM) or the Advisory Committee on Vaccines (ACV) to provide independent advice on a submission. Under the old TGA guidance, ACM aimed to send advice to the applicant on the 15th day of the month of the meeting. The guidance offered no comment on the timing of ACV advice.
TGA updated the guidance last week. The new document states ACM will “generally” send advice 10 working days after the meeting. ACV will send advice 12 working days after a meeting. TGA said the new timeframes are in line with current practice.
The updated guidance also features new advice on compiling the pre-meeting response. TGA wants applicants to limit their responses to 10 pages, at most, in at least 12-point font. The applicant should include a tabulation, typically of up to six pages, of any serious unexpected adverse drug reactions which are not mentioned in the proposed Australian Product Information and have not been submitted previously as a separate document.
Other separate documents requested by TGA include the updated proposed Australian Product Information, the most up-to-date Consumer Medicines Information and a statement on the current international regulatory status of the medicine. Applicants must send the information as electronic submissions, either via email or on electronic media.
TGA also added an explanation for its existing request that applicants submit the pre-meeting response at least 13 working days before they are due to sit down with ACM or ACV, stating that the target is needed to ensure the advisory groups have enough time to consider the information. 
Other changes include the deletion of a section about the pharmaceutical subcommittee (PSC). The old guideline said PSC advises ACM on the pharmaceutical chemistry, quality control, bioavailability and pharmacokinetics of prescription medicines proposed for registration in Australia. All references to PSC, except a broken link to a now-deleted section, have been removed from the guideline.
TGA Guidance
Philips recall triggers TGA post-market review of ventilators, CPAP and BiPAP devices
TGA has begun a post-market review of ventilators and positive airway pressure devices in response to the recall of devices by Philips over a safety concern. The review covers all sponsors, but the safety concerns are currently limited to Philips’ devices.
Philips is recalling millions of ventilators and continuous and bi-level positive airway pressure (CPAP/BiPAP) devices from markets around the world over concerns about their sound abatement foam. The polyester-based polyurethane foam may degrade into particles that are ingested or inhaled by the user, or off-gas certain chemicals. The particles and gas could theoretically cause health problems ranging from headaches to respiratory issues and cancer.
In light of the concerns related to Philips ventilators, CPAP and BiPAP devices, TGA wants to ensure other similar products in the Australian Register of Therapeutic Goods (ARTG) conform to its essential principles and remain safe to use.
To achieve those goals, TGA is asking sponsors of all ventilator, CPAP and BiPAP devices in the ARTG to share details of the type of soundproofing foam they use, the manufacturer's risk assessment and risk mitigation strategies and whether the products pose any “unnecessary risk” to the user's health during normal use. TGA is reviewing the submissions and will publish its findings “in due course.”
TGA Notice
PMDA shares update on efforts to improve communication with patients
Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) has posted details of a clutch of initiatives intended to improve its communication with patients. PMDA stepped up its patient engagement activities in response to “the spread of unreliable public health information through social media during the COVID-19 pandemic.”
The agency’s interest in improving its communication with patients predates the pandemic, but PMDA chief executive Fujiwara Yasuhiro said the topic became “a pressing urgent issue” as COVID-19 dialed up the need for “reliable and accurate information with plain language.”
In an open letter, Yasuhiro described three ways PMDA is trying to improve communication. The PMDA website is one area of focus. PMDA already provides a free consultation service on drugs and medical devices, and a guide for people receiving vaccines. The agency is now reviewing the website to identify opportunities to provide more information.
Yasuhiro also highlighted relief services for adverse drug reactions. PMDA holds consultations that address issues “including mental matters” with the recipients of relief services, and is running a quality of life study with people who suffer serious and rare reactions to drug products.
Finally, Yasuhiro discussed PMDA’s patient-centricity working group. PMDA set up the group to actively and systematically collect opinions and knowledge from patients. Yasuhiro expects the group to release its first draft guidance document soon.
PMDA Letter
New Zealand seeks feedback on risks and benefits of opioid medicine
The New Zealand Medicines and Medical Devices Safety Authority (Medsafe) is holding a consultation about the risks and benefits of the opioid medicine dihydrocodeine.
Last month, Medsafe asked Mundipharma and Teva Pharma, the two sponsors of dihydrocodeine in New Zealand, to provide evidence that their products are safe and effective. The request followed a Medicines Adverse Reactions Committee recommendation to review the risks and benefits of the drug, which is used to relieve pain after surgery, in relation to cancer and in some other contexts. 
The committee made the recommendation after finding that, while prescribing of dihydrocodeine in New Zealand was low, “The proportion of patients hospitalized from substance abuse and poisoning, associated with this medicine, was high.”
Medsafe’s review of the medicine could lead to the imposition of conditions on its use or the revocation of the consent to distribute the drug. To gauge the impact of any actions, Medsafe is asking for feedback on the risks and benefits of dihydrocodeine from consumers and healthcare professionals. Medsafe is accepting feedback until 24 September.
Medsafe Notice
Philippine FDA shares advice on transition to ASEAN harmonized technical requirements
The Philippine Food and Drug Administration (FDA) has released guidance on the transition to new harmonized technical requirements for medical devices.
FDA published guidelines on the authorization of medical devices under the Association of Southeast Asian Nations (ASEAN) harmonized technical requirement in 2018, and followed up with other texts over the subsequent years. However, the documents lack details for the period in which companies may be allowed to make and trade products without a Certificate of Medical Device Notification (CMDN).
The new update addresses that gap. FDA is allowing all Class B, C and D medical devices that came to market before the update to be made and traded without a CMDN until 31 March 2022. Until then, a license to operate the medical device establishment can be used.
From 1 April 2022, companies will need either a CMDM or a pending application for the certificate. The rules will change again on 1 April, 2023, when FDA will stop accepting pending applications for a CMDN. Certificate of Exemption documents issued before 25 February 2014 will remain valid until the end of March 2022 to “provide ample time for the industry to apply for CMDN.”
FDA Notice


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