Periodic safety update reporting companies

The data sheet is called the package insert in Japan, as it can be found in the drug packaging. The data sheet is drafted by the company and checked and completed by the authorities after the NDA review and the recommendation for approval. The content has been defined by the MHLW notification, and was revised in May 1997. Besides general information on the product, the most important entries are warnings, precautions and contraindications, and a list of adverse events quantitatively reported. These entries will be revised if necessary, with the safety data regularly analyzed for the periodic safety update report however, an ad hoc revision is made at any time in case of serious events. 

The company has a legal obligation to report all suspected serious ADRs occurring in the European Union to the Licensing Authority within 15 days of the receipt from any health professional. Serious and unexpected suspected ADRs are required to be reported from outside the EU within 15 days of receipt from health professionals. All other ADRs should be reported in the periodic safety updates. 

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