Asia-Pacific Roundup: Malaysia’s NPRA starts recognition procedure pilot for drugs approved by FDA and EMA
Malaysia’s National Pharmaceutical Regulatory Agency (NPRA) has begun piloting a fast-track registration pathway for products authorized in the European Union or United States.
NPRA started the one-year pilot to evaluate expanding the scope of its facilitated registration pathway, which currently includes verification and abbreviated routes. The new route is intended to leverage prior approvals granted by trusted reference authorities to accelerate access to pharmaceutical products and support regulatory efficiency by reducing the duplication involved in full regulatory reviews.
The eligibility criteria are distinct from the other routes. During the pilot, companies that have received approval for new drug products, biologics, and generics from the European Medicines Agency or US Food and Drug Administration can apply for an accelerated regulatory review in Malaysia. Generic medicines authorized in Europe via the decentralized procedure are among the eligible products.
To be eligible for the pathway, companies must send NPRA a complete submission dossier within three months of receiving approval from the reference agency. NPRA will reject incomplete dossiers during its screening process and refuse to accept the product into the accelerated pathway unless the company resubmits a complete dossier within the three-month window.
NPRA aims to process applications filed under the pathway in 60 working days, starting from when it receives payment following the completion of screening. The timeline excludes periods when the clock is paused awaiting the applicant’s response. Applicants have up to three rounds of correspondence with the NPRA.
Companies can participate in the pilot by using NPRA’s QUEST system to submit a dossier that is identical in content to the one authorized by their chosen reference agency, plus a cover letter confirming their intent to use the route. Manufacturing, packaging, testing, and batch release sites for the drug product and the drug substance must be the same as those approved by the reference agency.
Where applicable, applicants should submit stability data for Malaysia’s climate. Studies should comply with regional guidelines on drug product stability. NPRA expects companies to submit a minimum of 12 months of real-time and six months of accelerated stability data.
The agency is running the pilot to evaluate the proposed procedure and eligibility criteria for the new route. NPRA will use the pilot to inform the formal incorporation of the route into the next version of its facilitated registration pathway guidance. After using the pilot to test and refine the procedure, NPRA will extend the scope of the pathway to include products approved by other reference agencies.
Philippine FDA makes plan to move past ‘series of structural and operational challenges’
The Philippine Food and Drug Administration (FDA) has approved a five-year development plan intended to help it move past its recent structural and operational challenges.
FDA’s challenges include persistent backlogs, limited manpower, and gaps in digital and IT infrastructure, the agency said. With the problems showing “the urgent need for transformation,” FDA Director General Paolo Teston has established a strategic roadmap designed to turn the agency into “a more responsive and future-ready institution.”
Developed with the FDA management committee, the plan marks “a unified commitment” from leaders to sustain and build upon ongoing reforms, accelerating progress, the agency said. FDA committed to ensuring the uninterrupted delivery of regulatory services and processing of applications as the reforms are implemented.
The agency’s recent first-quarter report showed the need for improvements. FDA had onboarded 43 people by February to accelerate application processing and clear the backlog. Yet while the agency processed 3,662 applications in the analyzed period, it received 4,914 new filings, causing its backlog to grow to 18,030. FDA estimated it needed 100 more people to deliver its services.
India updates medical device marketing code to fix problems with foreign HCP training
India’s Department of Pharmaceuticals (DoP) has updated the medical device marketing code to resolve feedback about problems with foreign training for healthcare professionals (HCPs).
Industry groups and their members told DoP the code needed changing to make foreign HCP training approvals more predictable, ensure timely processing of requests, and reduce the compliance burden on medical device manufacturers. In response, DoP updated the Uniform Code for Marketing Practices in Medical Devices 2024.
Under the old Code, DoP prohibited overseas continuing medical education events except for “advanced clinical trainings in exceptional circumstances.” Companies had to provide detailed justification for any overseas training, plus details of the HCPs, equipment, and travel involved, at least three months before the event. Prior approval was needed to hold training events overseas.
DoP has softened the language in its update, saying that overseas events should “generally be avoided” and dropping the term “detailed justification.” Under the new Code, companies should share details of the training at least one month in advance and do not need prior approval to run overseas HCP events. DoP has changed subsections of the Code about travel and hospitality in line with the update.
Philippine FDA launches portal for submitting complaints and regulatory concerns
The Philippine FDA has set up the eSumbong portal to streamline the submission of complaints and regulatory concerns.
FDA called eSumbong “a vital tool for market surveillance and institutional integrity.” People can use the portal to report suspected counterfeit products and unlicensed establishments, as well as to complain about corruption, the application process, and issues with regulated health products.
Having integrated eSumbong into its website, FDA has decommissioned its eReport scheme and the associated email addresses previously used to submit complaints and concerns. Making eSumbong the sole platform for reports and complaints will ensure standardized intake and automated tracking, FDA said.
FDA has published guidelines to support the switch to the new system. The guidelines describe how to access eSumbong and use the portal to submit complaints and concerns. Once a complaint is filed, the system automatically sends emails to the relevant FDA office and the person who submitted the report.
India’s CDSCO pushes ahead with plan to reject applications with long-pending queries
India’s Central Drugs Standard Control Organization (CDSCO) is set to reject long-pending applications after working through its reminder process.
In January, CDSCO outlined plans to reduce its submission backlog by clearing filings that were on hold pending an applicant response to a regulatory question. The agency vowed to send three reminders 30 days apart to applicants before rejecting their submissions. Applicants with rejected submissions will forfeit their fees.
Months after setting out its policy, CDSCO has signaled its intent to send final rejection notices to companies that failed to respond to repeated requests for information. The agency advised stakeholders to ensure that all pending queries are addressed within the stipulated timeframe to avoid rejection of their applications. CDSCO will send disposal notices 30 days after issuing its third and final reminders.
Other News:
Australia’s Therapeutic Goods Administration (TGA) has canceled the registration of 10 medicines over the lack of evidence to support exercise performance claims. The medicines were part of a group of 21 magnesium-based products with exercise claims. Five products were backed by sufficient claims. Six products lacked evidence but stayed on the market after their sponsors dropped the claims. TGA Notice
Singapore’s Health Sciences Authority (HSA) took down 959 listings from local e-commerce and social media platforms as part of an Interpol clampdown on illegal health products. HSA Notice
