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
With tensions between the US and China still very high, many Western medical companies are looking for alternative places to make their products. Medical companies have looked more aggressively to Vietnam and India as new manufacturing hubs over the last few years. Not... Read More
1. Overview The Philippines Food and Drug Administration operates as a regulatory body within the Filipino government’s Department of Health. Its primary responsibility is to ensure the safety, efficacy, and quality of various health products including, drugs, medical devices, food, cosmetics, biologicals,... Read More
A recent report by Bain & Company and APACMed (a MedTech trade association located in Singapore) has issued a report on Asian MedTech companies’ growing appetite for ESG initiatives. According to this report, the Asia region has doubled its ESG policies compared... Read More
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 Philippines 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