Asia-Pacific Roundup: Philippine FDA consults on accelerated registration of WHO-prequalified products

RoundupsRoundups | 07 June 2022 |  By 

The Philippine Food and Drug Administration (FDA) is holding a consultation on its draft implementing guidelines on the collaborative procedure for the accelerated registration of World Health Organization (WHO)-prequalified pharmaceutical products and vaccines.
 
WHO issued a collaborative review procedure in 2013, and updated the text in 2016, to enable national regulatory agencies to leverage its scientific assessments to enhance their premarketing evaluation and registration systems. The collaboration gives national regulators access to privately held assessment outcomes to inform their decision-making and to educate their staff. FDA wants to make use of the system due to “the current resource constraints affecting drug regulation.”
 
FDA’s draft implementing guidelines apply to all FDA-licensed drug manufacturers, traders and distributors that have WHO-prequalified pharmaceutical products and vaccines and are seeking registration and post-approval changes.
 
In practice, FDA is adopting the WHO collaborative registration procedure as a registration pathway. The agency is asking companies that want to use the pathway to first ensure they have given WHO consent to share information with national regulators. The pathway is limited to products that are identical in quality and target the same indications as the ones covered by the WHO review. Applications filed under other facilitated review pathways, such as abridged review, cannot also benefit from the WHO procedure.
 
The implementing guideline also outlines the documentation that FDA expects applicants to submit, including country-specific paperwork such as foreign good manufacturing practices issued by FDA, labeling materials consistent with requirements in the Philippines and stability data generated in the hot and very humid IVb climatic zone.
 
After receiving a valid new product application, FDA will take up to 90 calendar days to evaluate the submission using the information provided by WHO. FDA will write to the applicant if it discovers it needs more information. The review time for postapproval changes is 30 days. Once the Philippine regulatory has reached a decision, it has 30 calendar days to inform WHO.
 
FDA is accepting feedback on the draft guidelines until 17 June. Once finalized, FDA will publish the text and bring it into force 15 calendar days after publication. The agency plans to review the order after three years.
 
Draft Guidelines
 
Malaysia’s MDA publishes guideline on the re-registration of registered medical devices
 
Malaysia’s Medical Device Authority (MDA) has finalized its re-registration guidance. The document covers the submission of re-registration applications for all classes of medical devices that have expired or near-expiry registrations.
 
MDA has established a two-step process for the re-registration of medical devices. First, the holder of the registration must apply for review by a conformity assessment body. The conformity assessment must cover the quality management system, postmarket surveillance system, technical documentation, and declaration of conformity. The body will also review any change notification documents approved by MDA. Companies can move on to the second step after undergoing a satisfactory assessment.
 
The second step covers the application for re-registration itself. Once a registration enters its final year, a re-registration button will appear in MDA’s system. Registration holders can then apply to re-register their devices through the MeDC@St application system. If a company has done change notifications, the button will show up on the completed change notification application. The button will not appear if the change notification application is incomplete.
 
Exactly what information the applicant needs to provide depends on the nature of the medical device that is being re-registered. MDA is asking applicants with Class A sterile medical devices to upload their validation reports, while companies with combination products should provide an endorsement letter issued by Malaysia’s National Pharmaceutical Regulatory Agency.
 
MDA has provided a flowchart to walk applicants through the two-step process. The flowchart covers the timing of the payment of the application and registration fees, both of which are paid via the MeDC@St portal.
 
MDA Guideline
 
TGA fines Philips $96,000 for alleged late reporting of information on respiratory devices
 
Australia’s Therapeutic Goods Administration (TGA) has fined Philips Electronics Australia AU$133,200 ($96,000) for alleged breaches of therapeutic goods legislation. Philips is accused of failing to provide TGA with information in the legally required timeframes.
 
The fines relate to Philips’ continuous and bi-level positive airway pressure sleep apnea devices, also known as CPAP and BPAP machines, and its mechanical ventilators. Philips is in the middle of a recall of the devices over the discovery of a problem with the sound abatement foam. By mid-December, Philips had corrected 20% of the affected devices in Australia.
 
TGA said the “failure to provide information on deterioration of performance of these critical medical devices could lead to a serious deterioration in the user's health.” Australian regulations require sponsors to report certain incidents and performance issues about medical devices to the TGA.
 
Allegedly, Philips failed to meet its reporting requirements in relation to the “deterioration in the characteristics or performance” of several of its products. The fine is made up of 10 infringement notices of AU$13,320 for each of Philips’ entries in the Australian Register of Therapeutic Goods.
 
TGA Notices
 
India rethinks drug tracking plan after no bidders meet terms of the original proposal
 
India’s National Pharmaceutical Pricing Authority (NPPA) has withdrawn its request for expressions of interest in a contract to help track certain medicines throughout the country’s supply chain.
 
After struggling to track stocks of medicines during the COVID-19 pandemic, NPPA sought a contractor to develop and operate a National Pharma Dashboard. The plan was to have drug manufacturers and other players in the Indian supply chain publish their stock positions to create “a national level representation of the availability of essential medicines.”
 
Almost two months after seeking interest in the opportunity, NPPA has canceled the proposal because it was unable to find bidders who met its terms. The pricing watchdog plans to issue a fresh proposal with revised terms “shortly” to restart the process.
 
NPPA Notice
 
Pakistan suspends high-dose painkillers after finding absence of safety and efficacy data
 
The Drug Regulatory Authority of Pakistan (DRAP) is suspending the registrations of 75mg and 100mg doses of the painkiller diclofenac potassium. DRAP took the action after learning the doses are not approved by reference regulatory authorities and finding a lack of safety and efficacy data.
 
Discussions about the status of the two doses began in 2016 and have led companies to take Pakistani authorities to court. DRAP discussed the events to date at a meeting of its registration board, where the members heard how reference regulatory authorities recommend a dose of 50mg and the use of the lowest effective dose for the shortest duration.
 
After reviewing submissions from the affected companies, the board decided to suspend all registrations of 75mg and 100mg doses. The suspension will last one year or until safety and efficacy are demonstrated in indigenous clinical trials. Until then, the affected manufacturers are to suspend production and importation and withdraw existing stocks from the market.
 
Meeting Minutes
 
Other news:
 
Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) has published a notice about the appropriate use of automated external defibrillators. PMDA Notice

 

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