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What post-market monitoring mechanisms are in place to ensure the ongoing safety and efficacy of medicinal products after marketing authorisation has been granted?

The Food and Drug Administration (FDA) imposes the post-marketing controls to monitor manufacturing facilities and product quality and safety after approval has been granted. The objective is to ensure ongoing compliance with both previously approved requirements and current standards, legislation and notifications.

Occasionally, the FDA randomly selects and spot-checks products in the market, and tests them to ensure that the ingredients are true to the pre-approved product licence label. The surveillance programme for consumers’ safety works hand-in-hand with the operators’ required pharmacovigilance to protect consumers from dangerous products. The FDA also uses research and epidemiological data, which includes technical information on adverse events.

Manufacturing facilities that have previously been approved are inspected to ensure ongoing compliance with the Good Manufacturing Practice certification and the Pharmaceutical Inspection Cooperation Scheme (PIC/S) – an extension of the Pharmaceutical Inspection Convention.

To ensure that Thailand’s post-market monitoring procedures and requirements meet the standards of the Association of South East Asian Nations, the Ministry of Public Health issued a notification on the procedures for the submission of Device Defect Reports or Adverse Event Reports and the ensuing Field Safety Corrective Action Reports, which came into effect on November 4 2016.

Data protection

What data protection issues should be considered when conducting pharmacovigilance activities?

There are no specific laws or regulations governing data protection when conducting pharmacovigilance activities. However, the general principles of data protection measures should be applied. As the pharmacovigilance activities would include reports on adverse events due to the use of medicinal products, this would include disclosure of patient information, which could violate patient confidentiality. Thus, consent must be obtained from patients before or upon the collection, use, or disclosure of personal data. To obtain consent, the purpose of using the personal data and details of the entity that will use this data must also be stated, such as the transfer of personal data between affiliated companies or hospitals.

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