2nd DIA Labeling Workshop in Japan

How Pharmaceutical Labeling Staffs, PMDA, and Package Labeling Users Can Ensure Appropriate Labeling Revisions

The contents of a pharmaceutical package label are drafted from the clinical trial and post marketing data obtained by applicants in foreign countries, who participate in new drug applications. During the review process, package labeling is then discussed with applicants and regulators (Pharmaceutical and Medical Device Agency; PMDA). Once the final package label is approved, the information is then used in the medical field. When new drug safety information is found and/or serious adverse affects arise, pharmaceutical companies need to consider revising their package label. However, there is some diff erentiation between revision logic and timing between each company. For this reason, global companies should consider harmonization with foreign countries’ labeling practices and/or CCDS. Due to the fact that there are variations between PMDA logic and theory, package labeling is a major focus for many pharmaceutical companies.

The 2nd Labeling Workshop will focus on labeling revision, same as the 1st workshop, as well as revision ideas of pharmaceutical companies and the PMDA, to help facilitate future effective labeling revisions.

Highlights
• Participants will use sample data to create revised package labeling and PMDA will resolve concerns and unclear points on labeling revision activities.
• Features representatives from industry, PMDA, and medical pharmacists.