Safety data exchange agreements
27 Oct 2018
The current outlook in the pharma world is to jointly develop and market medicinal products. Different companies take responsibility for bringing the drug to the market including manufacturing, activities involved with license approval from regulatory authority, distribution of the medicinal products in the market, etc. This has led to a large amount of data being gathered and exchanged between different stakeholders.
In the current era of pharmacovigilance and safety monitoring of medicinal products, there are specific requirements for companies to properly collect the safety data, exchange the data in a timely manner and in the required format. The data needs to be uploaded in a database and shared with the regulatory authority, as applicable.
Hence, companies must develop a well documented written agreement which will encompass all the information regarding the exchange of safety data. This agreement is essentially known as “Safety data exchange agreement” (SDEA). This is a written agreement between business parties with regards to the pharmacovigilance roles and responsibilities, based on the shared nature of relationship.
The agreements should have relevant provisions to ensure that the activities in the document are being carried out correctly. During inspections and audit, this agreement is asked for specifically and reviewed.
SDEAs are prepared between different stakeholders:
- Marketing authorisation holder and Manufacturers
- Marketing authorisation holder and Distributors
- Marketing authorisation holder and MAH licensing partner or Cross licensing partner
- Marketing authorisation holder and batch release site
The agreement between marketing authorisation holder and distributor and that with MAH licensing partner or cross licensing partner is the most critical as there are high chances of getting safety data at distributor or MAH licensing partner or Cross licensing partner’s end.
Since this agreement is binding on all the partners, the Legal department should review and approve the document. Usually, companies develop the SDEA template.
Key aspects which should be covered in SDEA are:
- Definition of terminologies and language of communication
- Format and mode of communication
- Products and territory for agreement
- Exchange of medical or product enquiries and quality complaints- timelines, format and responsibilities
- Exchange of cases- timelines, format and responsibilities
- Exchange of aggregate reports- timelines and responsibilities
- Exchange of validated signals- timelines, responsibilities, information on communication to regulatory authority
- Information on pharmacovigilance management system
- Reconciliation method and frequency
- Safety database
- Responsibility during regulatory inspections for PV
- Data privacy and confidentiality clause
- Business continuity plan
- Termination clause
- Revision details- when and how
- Contact details e.g. Phone no, email ID for communication of safety related details
Larger companies usually have one or more individuals or a separate team dedicated to preparing, tracking and enforcing SDEAs. It is essential that all the activities are carried out as per the timelines mentioned. There should be a proper tracking mechanism for defaulters, and provisions for appropriate corrective and preventive measures to be implemented.