10. License partner and Regulatory authority reports

License partner reports:

A Pharma company get into a licensing agreement with third party to produce or market a drug formulation that the other company has developed. Each license partners does have pharmacovigilance agreement to meet safety requirements in marketing country.

Pharmacovigilance Agreement means an agreement entered into by the Pharma companies to set forth the protocols and procedures for reporting adverse events and complying with reporting requirements set forth by Regulatory Authorities. 

The main objective of pharmacovigilance agreement is to define a mechanism that ensures the flow of safety related information from the end customer to competent authorities via MAH. 

Elements that include in pharmacovigilance agreement:

1. The type of cases collected by each partner needs (e.g. post-marketing, clinical studies, registries, market research), as well as whether both serious and non-serious cases are required to be exchanged. 
2. The party that responsible for safety exchange in which territory. 
3. Special situations and the expectations for collecting cases associated with these instances. 
4. All of the above is important to ensure no sources of safety data are missed and conversely that there is not a duplication of case submissions. 
5. The format in which cases are exchanged also specified. This is important to ensure that the format is compatible with what the global PV database holder requires for import and submission of  cases. 
6. The timeline for exchange of cases, including a definition of day zero to ensure there is no misunderstanding between partners. 
7. Aggregate reports, the responsibilities for the preparation of the report; who will write the report, what are the responsibilities of the supporting party. 
8. GVP Module VI states “The clock start for the submission of ICSRs begins with awareness of the minimum information by either the organisation or the contractual partner (whichever is the earliest).” 
9. This being defined in the PVA, along with how many working or calendar days the partner has to forward the cases to the MAH, ought to minimise late submission of cases to regulatory authorities. Including this case exchange information, should ensure that each company will receive the reports it needs to meet regulatory authority requirements.

The cases received from other pharmaceutical company which has PVA agreement need to be handled as license partner cases.

Regulatory authority cases:

If consumer or healthcare professional directly report adverse events to regulatory authority (i.e, FDA, EMA etc..) not to marketing holder (pharmaceutical company), then those reports will be shared to marketing holders by regulatory authorities. This type of cases which were received by companies from regulatory authority are to be handled as regulatory authority cases.

Individual serious unexpected adverse drug reaction reports originating from foreign regulatory authorities are subject to expedited reporting to other authorities by each marketing holder. Re-submission of serious cases without new information to the originating regulatory authority is not usually necessary, unless otherwise specified by local regulation.