Philippines Food and Drug Administration (FDA) releases a draft schedule of fees for Licensing, Registration and Regulatory Services for public comments

2020-02-04T13:48:34+08:00 January 28th, 2020|Insight, Medical Regulation Updates, News & Events|
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The new draft schedule of fees and charges shall apply to all persons, establishments and health products under the FDA’s jurisdiction. This includes, but is not limited to, national and local government agencies, state colleges and universities, public schools, private entities, and non-governmental organizations who utilize the FDA’s services.

The FDA is rationalizing and streamlining its fee structure to strengthen regulatory enforcement and post-marketing surveillance activities, and to address rising operational costs and expenses for qualified personnel who have technical skills in the evaluation of health products, inspection of establishments and/or laboratory testing. Furthermore, it also aims to sustain the cost of the development, maintenance, and upgrading of information and communication technology and online systems.

The draft new schedule of fees and charges shall apply to all persons, establishments and health products under the FDA’s jurisdiction. This includes, but is not limited to, national and local government agencies, state colleges and universities, public schools, private entities, and non-governmental organizations availing of the FDA’s services.

The new schedule of fees and charges applicable to the Center for Device Regulation, Radiation Health and Research (CDRRHR) is outlined below. The application fees shall not cover the University of the Phillipines Law Center’s Legal Research Fee (LRF), which is equivalent to Php 10.00 or 1% of the application fee, whichever is higher, and the fees incurred from the use of payment collection facilities, such as service fees charged by banks authorized to collect fees on behalf of the FDA.

The application fees for granting the authorization stated in the draft issuance shall cover the expenses of all or any of the following activities:

1) Receiving of application documents;
2) Pre-assessment of received applications for product market authorizations;
3) Pre-marketing activities, including but not limited to assessment, technical evaluation and pre-licensing inspection of establishment;
4) Post-marketing surveillance of products and establishments: (a) Collection of samples (b) Laboratory testing (c) Complaints and reports processing (d) Safety monitoring (e) Post-licensing inspection (f) Routine inspection (g) Pharmacovigilance
5) Printing;
6) Records management and archiving; and
6) Courier services to deliver the authorization.

The FDA plans to implement these revised fees in 2020 (except as otherwise stated in its Annexes).