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Chapter: Pharmacovigilance: Periodic Safety Update Reports

The Committee for Medicinal Products for Human Use (CHMP) of the European Agency for the evaluation of medicinal products (EMEA) has published a position paper on compliance with pharmacovig-ilance regulatory obligations.


BEST METHODS OF COMPLIANCE

The Committee for Medicinal Products for Human Use (CHMP) of the European Agency for the evaluation of medicinal products (EMEA) has published a position paper on compliance with pharmacovig-ilance regulatory obligations (CPMP, 2001). This paper, which came into effect in January 2002, empha-sises the importance of compliance with periodic reporting and lists the forms that non-compliance may take:

·    Submission: Complete non-submission of PSURs, submission outside the correct cycle or outside the correct timeframes and non-restart of the cycle of submission when necessary;

·    Format of the Document: Report not in accordance with ICH E2C;

·    Concealment of Information, Particularly in the Following Sections of the Report: Update of regu-latory authority or MAH actions taken for safety reasons, changes to reference safety information, patient exposure and presentation of individual case histories;

·        Poor Quality Reports: Poor documentation of ADR reports or insufficient information provided to perform a thorough assessment in the presen-tation of individual case histories section, new safety signals not or poorly assessed in the overall safety information section, misuse not highlighted and absence of standardised medical terminology;

·    CCDS: Where changes have been made to the CCDS since the submission of the last PSUR and submission of a report where the covering letter does not highlight the differences between the CCDS and the EU or national SPC and

·    Previous requests from Competent Authorities not Addressed: Submission of a report where previous requests from competent authorities have not been addressed (e.g. close monitoring of specific safety issues).

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