Pharmacovigilance Requirements Clarified by the FDA of the Philippines

The Department of Health of Republic of Philippines has issued a Circular No. 2020-003 effective on 26 February 2020  to provide clarification on the guidelines on pharmacovigilance obligations. The circular is relevant to market authorizations holders (MAH) such as manufacturers, processors, traders, sellers, distributors, importers, exporters, and wholesalers of drugs and biological products for human use.

The circular addresses several issues including but not limited to unclear guidelines on timelines, mechanism, and redundancy of the MAH to conduct clinical trials in the local setting as well as safety concerns.
The guideline requires a qualified pharmacovigilance officer to be designated by MAH to oversee the effective implementation of the pharmacovigilance system and the submission of documents.

The provision of the circular spells out the requirement to monitor and record pharmacovigilance activities. In the event of adverse reactions, the MAH should refer to the circular pertaining to the reporting time frame and information required in the framework. Complete information entails details on the patient, adverse reaction, the product or substance, and the reporter. The submission of adverse reaction reporting can be done via The Council for International Organisation of Medical Sciences (CIOMS) I form or through the electronic E2B format.

The reporting framework also applies to serious spontaneous reactions that occur locally as well as overseas occurrence that involves a Filipino and a product obtained from the Philippines. Other types of reporting include reports obtained from data collection system, reports for another MAH, consumer reports, reports of lack of efficacy, overdose and off-label use, medication errors, product defects, the outcome of use during pregnancy, data obtained from social media and internet, local case report from scientific literature, suspended, withdrawn or canceled product registration.

A robust risk management plan is specified for MAH to implement and pharmacovigilance inspections also will be carried out to ensure the compliance of the circular by FDA.
This circular aims to ensure that the safety and efficacy of drug products are not compromised.

More information pertaining to the Circular No 2020-003 can be referred here https://ww2.fda.gov.ph/attachments/article/654521/FDA%20Circular%20No.2020-003.pdf