Asia-Pacific summary: TGA updates schedule for prescription drug registration process

Australia’s Therapeutic Goods Administration (TGA) has updated the schedule for the expert consultative review phase of the prescription drug registration process. TGA now aims to send a notice to the requester 10-12 business days after the meeting.

The Australian registration process includes the option for the Medicines Advisory Committee (ACM) or Vaccine Advisory Committee (ACV) to provide independent advice on a submission. Under the old TGA directive, the ACM aimed to send a notice to the requester on the 15th day of the month of the meeting. Guidance offered no comment on the timing of the ACV notice.

TGA updated the guidelines last week. The new document says the ACM will send advice “usually” 10 working days after the meeting. ACV will send a notice 12 working days after a meeting. TGA said the new deadlines are in line with current practice.

The updated guide also contains new tips on compiling the pre-meeting response. TGA wants applicants to limit their responses to a maximum of 10 pages in a font of at least 12 points. The applicant should include a table, usually no more than six pages long, of all serious and unexpected side effects of drugs which are not mentioned in the Australian product information offered and which have not previously been submitted in a separate document.

Other separate documents requested by the TGA include updated proposed Australian product information, the most recent information on consumer drugs and a statement on the drug’s current international regulatory status. Applicants should send the information in the form of electronic submissions, either by e-mail or electronically.

TGA also added an explanation to its existing request that candidates submit the pre-meeting response at least 13 working days before sitting down with ACM or ACV, stating that the goal is necessary to ensure advisory groups have sufficient time to review the information.

Other changes include the removal of a section on the Pharmaceutical Subcommittee (PSC). The old guideline stated that the PSC advises ACM on pharmaceutical chemistry, quality control, bioavailability and pharmacokinetics of prescription drugs offered for registration in Australia. All references to the PSC, except for a broken link to a section now deleted, have been removed from the directive.

TGA Guide

Philips recall triggers TGA post-market review of ventilators, CPAP and BiPAP devices

TGA has started a post-market review of ventilators and positive airway pressure devices in response to Philips’ recall of the devices for a safety issue. The review covers all sponsors, but security concerns are currently limited to Philips devices.

Philips is recalling millions of Continuous Positive Airway Pressure and Dual Stage (CPAP / BiPAP) ventilators and devices from markets around the world over concerns about their noise-reducing foam. Polyester-based polyurethane foam can break down into particles that are ingested or inhaled by the user, or give off certain chemicals. The particles and gas could theoretically cause health problems ranging from headaches to respiratory problems and cancer.

In light of concerns related to Philips ventilators, CPAP and BiPAP devices, TGA wants to ensure that other similar products listed in the Australian Therapeutic Products Registry (ARTG) comply with its Fundamentals and remain safe to use.

To achieve these goals, TGA is asking sponsors of all ARTG ventilators, CPAPs and BiPAPs to share details about the type of sound deadening foam they are using, risk assessment, and risk mitigation strategies. manufacturer and whether the products present an “unnecessary risk” to the health of the user during normal use. TGA is reviewing the submissions and will release its findings “in due course”.

TGA Notice

PMDA shares update on efforts to improve communication with patients

The Japan Pharmaceuticals and Medical Devices Agency (PMDA) has released details of a series of initiatives to improve its communication with patients. PMDA has stepped up patient engagement activities in response to “the dissemination of unreliable public health information via 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 had become “an urgent and urgent matter” as COVID-19 called the need for “reliable and accurate information in simple language”.

In an open letter, Yasuhiro described three ways PMDA tries to improve communication. The PMDA website is one area of ​​interest. The PMDA already offers a free consultation service on drugs and medical devices, and a guide for people who have been vaccinated. The agency is currently reviewing the website to identify opportunities to provide more information.

Yasuhiro also pointed out the emergency services for adverse drug reactions. PMDA organizes consultations on issues “including mental issues” with beneficiaries of relief services, and conducts a quality-of-life study with people who suffer from severe and rare reactions to drugs.

Finally, Yasuhiro spoke about the PMDA Patient-Centered Working Group. The PMDA set up the group to actively and systematically collect the opinions and knowledge of patients. Yasuhiro expects the group to publish their first draft guidance document soon.

PMDA letter

New Zealand seeks feedback on risks and benefits of opioid drugs

The New Zealand Medicines and Medical Devices Safety Authority (Medsafe) is hosting a consultation on the risks and benefits of the opioid drug dihydrocodeine.

Last month, Medsafe asked Mundipharma and Teva Pharma, the two sponsors of dihydrocodeine in New Zealand, to provide proof that their products are safe and effective. The request followed a recommendation from the Adverse Drug Reactions Committee to review the risks and benefits of the drug, which is used to relieve pain after surgery, in connection with cancer and in certain other settings.

The committee made the recommendation after finding that while the prescription of dihydrocodeine in New Zealand was low, “the proportion of patients hospitalized for substance abuse and poisoning associated with this drug was high.”

Medsafe’s review of the drug may result in conditions being imposed on its use or consent to be withdrawn for distribution of the drug. To assess the impact of any action, Medsafe is seeking feedback on the risks and benefits of dihydrocodeine from consumers and healthcare professionals. Medsafe is accepting comments until September 24.

Medsafe review

Philippine FDA shares advice on transitioning to harmonized ASEAN technical requirements

The Philippine Food and Drug Administration (FDA) has issued guidance on transitioning to new harmonized technical requirements for medical devices.

The FDA issued guidelines on the authorization of medical devices under the Harmonized Technical Requirements of the Association of Southeast Asian Nations (ASEAN) in 2018, and has followed other texts over the years. following years. However, the documents lack details on the period during which companies can be allowed to manufacture and market products without a Medical Device Notification Certificate (CMDN).

The new update fills this gap. The FDA authorizes the manufacture and sale of all Class B, C and D medical devices placed on the market prior to the update without NDMC until March 31, 2022. By then, a license to operate the facility of medical devices can be used.

From April 1, 2022, companies will need either a CMDM or a pending certificate request. The rules will change again on April 1, 2023, when the FDA stops accepting pending NDMC applications. Exemption certificates issued before February 25, 2014 will remain valid until the end of March 2022 to “allow sufficient time for industry to request the NDMC”.

FDA Notice

© 2021 Society of Regulatory Affairs Professionals.


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