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Historically, there have been more drug clinical trials in the West than in Asia. However, recently this has changed, and there are more than 8,000 clinical trials in Asia now and less than  8,000 clinical trials in the West. Please note that... Read More

Recently, the Filipino FDA issued a new circular that will guide companies that import, distribute, manufacture, or sell medical devices. Issues are outlined on topics including shipping out products first that are close to the expiration date, first items into storage are... Read More

On June 16, the Filipino FDA issued circular 2022-0045 named “Establishing Facilitated Registration Pathway for Drug Products”. This circular discussed how Reference Drug Regulatory Agencies (RDRA) can expedite drug, vaccine, and biologic approvals in the Philippines. If an RDRA has approved a... Read More

The Filipino FDA has proposed a shorter review time for drugs if their clinical studies are completed successfully and approved by the US FDA, PMDA, TGA, EMA, and UK/Canadian FDAs. These approvals would only apply for drugs that can help with health... Read More

Digital healthcare trends are flourishing in Asia due to its aging population, shortage of healthcare personnel, increasing consumer demand, and technological innovation. According to statistics from Graphical Research, the digital health market in Asia Pacific is expected to grow by 33% from 2020... Read More

The Filipino FDA is now circulating a document that will allow abridged processing of device applications in the Philippines if the device has already been approved in another ASEAN country. Abridge processing refers to a quicker evaluation with respect to AMDD-CSDT requirements.... Read More

Under draft rules released in January by the Philippines Food and Drug Administration (FDA), all in-vitro medical devices (IVDs) imported, marketed, or manufactured in the archipelago nation will soon for the first time be required to be registered with health authorities in... Read More

Medical devices already approved for sale in Association of Southeast Asian Nations (ASEAN) countries may be eligible for fast-track access to the Philippines market, according to a directive issued in November by the Philippines Food and Drug Administration. Since February, Philippines regulatory... Read More

With regulatory authorities in the Philippines moving to tighten registration requirements for medical devices, manufacturers are voicing concern that government authorities are not building in enough transition time for industry to reasonably comply. Since January, Filipino authorities have begun phasing in new... Read More