E-EDPMS Data Upload Compliance

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FDA CIRCULAR NO. 2010-017: E-EDPMS Data Upload Compliance

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Title Supreme Court: E-EDPMS Data Upload Compliance

Law: Fda Circular No. 2010-017

Decision Date: Oct 4, 2010

The Department of Health and the Food and Drug Administration mandate the uploading of data to the Electronic Essential Drug Price Monitoring System by October 15, 2010, with non-compliance resulting in administrative penalties, including potential non-renewal of licenses under the Universally Accessible, Cheaper and Quality Medicines Act.

administrative law

drug regulation

A

Agencies Responsible for Monitoring and Enforcement

The Department of Health (DOH) through the National Center for Pharmaceutical Access and Management (NCPAM) and the Food and Drug Administration (FDA) jointly conduct nationwide monitoring of the system's implementation.

Legal Consequences of Non-Compliance

Entities failing to comply with the data upload requirement may face administrative sanctions.
Penalties are to be imposed according to the Implementing Rules and Regulations (IRR) of Republic Act No. 9502, also known as the "Universally Accessible, Cheaper and Quality Medicines Act of 2008."
Potential penalties include, but are not limited to, the non-renewal of the violator's License to Operate (LTO).

Scope and Purpose

The circular is part of the government's effort to effectively monitor essential drug prices electronically.
It aims to promote transparency, regulation, and accessibility of medicine prices nationwide.

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