|
|
|
|
|
|
|
The GCP [34] requires an investigator-in-charge to ensure the speedy reporting of all serious drug reactions that occur during clinical investigation to the head of the medical institution, the supervisory investigator, and the sponsor. It is the sponsor's responsibility to ensure the immediate reporting of all serious ADRs and deaths suspected of being drug related to the NDD. This applies to such foreign events as well as domestic incidents. All other ADRs should be reported in the NDA. Equally, for marketed drugs, the time for reporting serious ADRs, including foreign events, that cannot be predicted from the package circular, is 15 days from awareness. Also reportable in 15 days are events where the severity or frequency is greater than the package circular indicates. In the event of a death thought to be due to an unexpected ADR, the company must immediately advise the Safety Division by fax and follow up within the 15-day time frame. A 30-day time period is permitted for other serious ADRs and for nonserious, unexpected events. It is important to note, however, that while the above are the current requirements, physicians are tending to change their practice and report all serious adverse events and deaths to the Koseisho. Whether or not an adverse event is related to a drug treatment is a judgment call, and the tendency to pass the responsibility for making such judgments to the Koseisho is increasing. This is especially so in pre-NDA clinical trials. |
|
|
|
|
|
|
|
|
The guidelines on the Standard for Good Post-Marketing Surveillance Practice (GPMSP) was revised in June 1993 and took effect on April 1, 1994. It is likely that this will place Japanese postmarketing surveillance (PMS) among the best available by laying down procedures and requirements that should ensure the reliability of the data. It requires the product's manufacturer to set up a department independent of sales and marketing that can effectively function without hindrance from any quarter within the company. Staff must meet certain education and training requirements and are responsible for the collection of safety, efficacy, and quality data for all marketed drugs, from physicians and allied medical groups. They must assess and analyze the information, decide on any action, and ensure dissemination to health care practitioners, as necessary, by such means as changes to the package circular and Dear Doctor letters. The name of the manager of this department must be provided to the Koseisho as their communication link. All studies necessary to help in the evaluation of safety are designed by this group and, if conducted by others within the company, this group must maintain supervisory control and ensure that all PMS trials are carried out in compliance with GCP. The MHW will carry out inspections to confirm validity of data and ensure that the company is complying with GPMSP. |
|
|
|
|
|
|
|
|
To compensate for the limited clinical data for evaluation of drug safety at the time of marketing approval, in 1979 the MHW instituted a system for the reexamination of safety at either 4 or 6 years after approval as part of the |
|
|
|
|
|