Читать книгу Cobert's Manual Of Drug Safety And Pharmacovigilance (Third Edition) - William Gregory - Страница 40

Many countries follow the ICH/CIOMS criteria for reporting valid cases (four criteria: suspect drug, AE, patient, reporter) from spontaneous sources. It is important to triage every case immediately. If it is a serious AE and unlabeled, most jurisdictions require reporting to the health authority within 15 calendar days of first awareness. Some countries have different requirements which often revolve around receiving all domestic SAEs (whether labeled or not) but only some (SAEs that are unlabeled) non-domestic cases. Some countries do not want any non-domestic cases. Some non-English speaking countries require cases to be in the local language, particularly domestic cases.

Australia: Interestingly, Australia only requires Australian SAEs to be reported within 15 calendar days, whether expected or not, using their “blue card” system (the official Australian system to capture AEs is akin to the US MedWatch program and the United Kingdom Yellow Card system) as of this writing. In addition to the “blue card” reporting form (electronic web-form and on paper), the Therapeutic Goods Administration (TGA) accepts E2B ICSRs. Non-serious Australian AEs should be reported as line listings in the PSUR. For post-marketing studies done in Australia, similarly, all SAEs are to be reported in 15 calendar days and the non-serious AEs at the end of the study. Non-Australian cases do not have to be reported. Rather “any significant safety issue or action which has arisen from any analysis of foreign reports, or which has been taken by a foreign regulatory agency, including the basis for such action” should be reported to the health authority (TGA) within 72 hours (www.tga.gov.au).

Canada: Health Canada requires all domestic reports of serious ARs and “unusual failure in efficacy for new drugs” be reported within 15 calendar days. Foreign unexpected serious adverse reactions must be reported in 15 calendar days.

There is now a transition by companies reporting serious AEs to health agencies from paper or fax reporting of paper forms (CIOMS I) to electronic reporting using a standardized electronic format and transmission known generically as “E2B transmissions” after the ICH document of that name. This reporting is either through the Internet (using an electronic gateway or direct entry online into the database). In theory, electronic case transmission of a case is the same to all agencies around the world and simplifies the multiple reporting obligations now in force from country to country. This has not turned out to be entirely the case, however, as various countries (notably the US, Japan, and China) want special or additional information and data in the electronic transmission. Further, the EMA has created a new paper form for output of E2B(R3) ICSRs. Note that most of the local customization relates to administrative detail and not the medical case.