The Pharmacovigilance Service Provider

Abbreviated for functional purposes to ICSRs, these documents are central to all Pharmacovigilance Service Provider and from a regulating point of view they are completely non-negotiable. ICSRs must be compiled for every medicine or medicinal product to be legally marketed. They must be submitted at pre-defined intervals and coordinated by correct professionals.

 ICSRs are vital to the ongoing process of keeping track of each product's drug safety profile. From a regulatory standpoint, they are there to ensure any and all known concerns are applied in a timely and proportionate manner. They also help contribute to the knowledge base of Pharmacovigilance Service Provider in the overall scheme of things.

 ICSRs need to be gathered according to a very precise format stipulated by the regulatory authorities. This not surprisingly includes all appropriate practice guidelines and language. The rules themselves are necessarily complex and in addition the number of other practice guidelines they refer to is substantial to say the least. In many senses, one of the challenges pharmaceutical companies face is simply to submit the details in the correct format. If it does not meet the standard, regulators take various steps to ensure the company either returns to concurrence or restrict the manner in which the product can be sold. This can even include suspending it from sale completely.

 Some of the key conditions relate primarily to the correct procedures for processing ICSRs. The policies address Electronic Data Interchange (EDI) of Individual Case Safety Reports (ICSRs) and Medicinal Product Reports (MPRs) at all stages of the product's lifespan. They stipulate the language to be used when describing dosing. They provide instructions on processing issues for Safety Messages. They also provide detailed help with the management of any SUSARS - Suspected Unanticipated Serious Adverse reactions. There are then a large number of further guidance on a variety of other drug safety topics. Again, these are all necessary.

 There is a requirement for Pharmacovigilance Service Provider detailed case narratives within ICSRs in an accepted and acceptable manner. There may be times when not all the information is actually available to complete the file format of the case plot. Whilst there is some provision for such instances, the range of allowable situations is narrow. In essence, each ICSR is likely to be fully complete.