Good Vigilance Practice (GVP) And ADR Reports Via Companies

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Chapter: Pharmacovigilance: Pharmacovigilance and Risk Management in Japan

According to the GVP and ‘Good Quality Practice’ (GQP), which represents the license rules that MAH must follow, the ‘general manufacturing & marketing supervisor’ in the MAH should appoint a ‘quality assurance supervisor’ and ‘pharmacovigilance supervisor.’


GOOD VIGILANCE PRACTICE (GVP) AND ADR REPORTS VIA COMPANIES

According to the GVP and ‘Good Quality Practice’ (GQP), which represents the license rules that MAH must follow, the ‘general manufacturing & marketing supervisor’ in the MAH should appoint a ‘quality assurance supervisor’ and ‘pharmacovigilance supervisor.’ The pharmacovigilance supervisor controls all the safety issues in the safety control management department and should be independent from the sales department. The pharmacovigilance supervisor has the responsibility for collecting and analysing safety information, planning and execution of measures to ensure safety, planning and execution of the EPPV, audit, training/education of relevant staff, and prepa-ration of Standard Operating Procedures (SOPs) for these activities.

According to the 2002 PAL amendment, the definition and standards for expedited reporting of post-approval ADR reporting was revised in 2005 when more emphasis was placed on recording the serious reactions in line with the implementation of ICH-E2D guideline in April 2005. Before April 2005, the drug company had to submit domestic report of ‘moderate’ unexpected reactions (where ‘moderate’ was defined as intermediate between ‘serious’ and ‘mild’) within 30 calendar days from the first receipt of the case report. In addition, prior to April 2005 all domestic reports of the expected serious reactions should also be submitted within 30 calendar days. However, since 1 April 2005, non-serious reactions have been excluded from those requiring the expe-dited reporting, though they should be included in the periodic report of unexpected and non-serious ADRs. Under the new regulations, when the MAH is aware that a domestic case has experienced an expected and fatal ADR, the reaction should be reported within 15 calendar days. In addition, all the expected serious reactions should be reported within 15 calendar days during the EPPV and during the first 2 years after the approval of a new chemi-cal entity. All the expected and unexpected serious cases of infection due to the use of any kind of drug should be reported within 15 calendar days and non-serious unexpected domestic cases of infections should be also reported within 15 calendar days. The MAH should also meet the research report require-ment (including papers published in scientific journals and meetings) as well as the requirement to report on the safety measures taken in the foreign countries.

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