Rare disease care across Asia is advancing on two fronts: faster regulatory pathways for orphan drugs, and slow-building efforts to fund and diagnose the roughly 258 million people in Asia living with rare conditions. China’s revised Drug Administration Law implementing rules, effective... Read More
The Philippine Food and Drug Administration (FDA) has released a draft circular introducing clearer and more detailed post-market surveillance (PMS) requirements for medical devices. The proposal aims to strengthen traceability and improve how medical device safety issues are monitored and addressed. The draft is based on... Read More
Western drug companies are demanding improvements to Korea’s “Innovative Company” criteria. Up until now, the Korean government has been choosing innovative firms every two years. Since the program started, there have been 49 designated innovative drug companies, but only 4 of these were... Read More
Introduction Quality, safety, and efficacy are of the utmost importance for drug products. A vital part in achieving this is having a Drug Master File (DMF). A DMF is a confidential submission to a health authority to provide detailed information about the... Read More
The Food and Drug Administration (FDA) of the Philippines has released a draft circular suggesting new guidelines for the recall of health products that have been authorized for sale and present a significant risk to public health. The new circular is intended... Read More
The Food and Drug Administration of the Philippines (Philippines FDA) officially declared that for Class A medical devices, the online application process to obtain the Certificate of Medical Device Notification (CMDN) is now the official route. Applicants must submit all CMDN applications through the... Read More
In late 2024, the FDA of the Philippines outlined a new regulation for all companies importing, exporting, manufacturing, and selling medical products. This new Administrative Order is Order #2024-0015, an update from an older 2020 regulation. The new order covers all types... Read More
Recently, The Asia Pacific Medical Technology Association (APACMed) released their position paper titled “Risk-based Change Management for Registered Medical Devices.” As noted in this paper, some Asian countries utilize risk-based methods for device changes, while others require change submissions no matter what... Read More
Recently, the Filipino FDA initiated a new pilot device registration system called the eServices Portal System. This announcement is under the FDA’s Advisory No. 2024 – 1089 II Pilot program. Basically, applicants for device approval need to be licensed medical device establishments with... Read More
In late March, the Philippines FDA (PFDA) has extended the registration date for Class B,C and D medical device registration for devices that were not already on the registrable medical device list. Now, these medical devices do not need to be registered until... Read More