Topic One: Case study
On Day 4, participants were divided into three groups and discussed about 3 cases on changes in manufacturing scale, method and in assay of drug product.
In the group work, staff members of the Office of OTC/Generic Drugs introduced PMDA's review policy on the necessity of application regarding minor changes.
Topic Two: Report the cases from participants
In the last session, cases in several countries were reported by the participants. The valuable information was provided to deepen understanding of the situations in other countries.
Comments from participants
Joining this training is a good opportunity for us to know about drug registration system in Japan. At this time, we can also exchange information of drug evaluation among overseas participants. This training has also informative topics with deep discussion. Hopefully, the information can be used as a references for our registration system improvement. Ms. Lusiana Puspita Sari and Ms. Wenny Trias Ramadanty, National Agency of Drug and Food Control (NADFC) Republic of Indonesia |
Kirigamine heights, Tochigi |
