For pharmaceuticals, quasi-drugs, and cosmetics, Article 14 of the Pharmaceuticals and Medical Devices Act (PMD Act) requires that each product must obtain approval from the Minister of Health, Labour and Welfare for manufacturing and marketing. For medical devices and in vitro diagnostic pharmaceuticals, this requirement is outlined in Article 23-2-5 of the same act. There are exemptions to these rules, so for more detailed information, please consult with us.
Using a safety database allows for automatic assignment of MedDRA and drug codes, significantly contributing to the reliability and efficiency of the work. Moreover, when creating periodic reports, data aggregation from the database greatly enhances the reliability of the document submission process to regulatory authorities.
Yes, if the PMDA finds the explanation for the scientific and rational basis insufficient, they may request a reclassification of the change.
Please check the link below for more details.
It is crucial to carefully consider what regulatory procedures are necessary for changes that could impact the product’s quality. We will thoroughly examine our client’s situation and propose appropriate solutions.
Many companies face similar issues. Please consult with us as various cases can be considered.
When creating a draft RMP for submission, many considerations need to be taken into account, such as evaluating the benefits and risks based on the product characteristics and information obtained during development, and considering overseas package insert drafts. Consult with us for guidance tailored to your specific situation.
The duration varies by prefecture, but if there are no issues with the application, it typically takes about 30 to 60 days.
