Postmarketing all-case surveillance trends and contribution to safety measures of drugs approved in Japan: a cross-sectional survey in 1999-2019.

ABSTRACT:

Background

Postmarketing all-case surveillance (PACS) is a safety monitoring activity predominantly conducted for drugs with few domestic clinical trials, orphan drugs, or anticancer drugs that potentially cause serious adverse events.

Aim

This study comprehensively analyzed drugs in Japan requiring PACS as an approval condition and those implementing PACS-results-based safety measures.

Method

We included drugs approved in Japan between 1999 and 2019.

Results

During the 20-year survey, 1871 drugs were approved in Japan, including 277 (14.8%) requiring PACS as an approval prerequisite. The drug number requiring PACS for approval and its ratio to the total approved-drug number is increasing annually. In 2018, the number and percentage of PACS-requiring drugs reac

SUBMITTER: Nakao M 

PROVIDER: S-EPMC9938803 | biostudies-literature | 2023 Feb

REPOSITORIES: biostudies-literature