Postapproval activities

Safety Division. The responsibility of this division is to provide services related to re-examin-ation and re-evaluation (cf. section or Postapproval Activities, below), postmarketing surveillance regarding safety and efficacy of drugs, quasi-drugs, medical devices and cosmetics. The Office of Appropriate Use of Drugs, attached to this division, collects and evaluates information related to ADRs and promotes the appropriate use of drugs. 

The Good Post-marketing Surveillance Practice (GPMSP). The postmarketing surveillance (PMS) system is a well established system in Japan for collecting safety data in order to prepare the documentation requested for re-examination which will be described in the section on Postapproval Activities, below. 

BACPAC I Intermediates in Drug Substance Synthesis Bulk Actives Postapproval Changes Chemistry, Manufacturing, and Controls Documentation, February 2001... 

Cui et al. (2002) organizes common errors in interpretation of subgroup results into a list of six categories, in a general setting that include both efficacy and safety end points. Many of the items on the list are mentioned earlier. Such list should serve as a useful reminder even for the case of safety end points. A proper interpretation allows one to take appropriate next steps, whether it is to plan for meta-analysis of fhe same drug prior to NDA, to plan for new clinical trial with target population, or to plan for postapproval safety activities. 

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