Not all companies would consider setting up affiliate offices/ subsidiaries in all countries, where they wish to operate or commercialize products. In such scenarios, the Pharma company may consider nominating a distributor or business partner. Besides, companies may even consider co-marketing arrangements in countries where they are already operating, by means of own-label or private label supplies, or by any other means such as co-promotional or out/in- licensing agreements.

Very often, the distributor may have limited knowledge or resources in Pharmacovigilance, which may be primarily attributable to their geographical location. At the end of day, Pharmacovigilance obligations lie with the marketing authorization holder (MAH), and hence it is necessary to have necessary safety data exchange agreements (SDEA) in place. At times, just having an SDEA may not be considered enough. There is also a need for considering periodic risk-based evaluation and audit.

The ideal strategy is to have a formal business partner evaluation process for qualifying a distributor, prior to signing off a commercial agreement. With this, it is possible to undertake a risk-based assessment (or even audit) in advance, with a pre-determined audit frequency. The European Medicines Agency recommends every MAH to have a 3-5 year strategic audit plan in place. Questionnaire-based assessment is no longer considered an audit.

Objective

The primary objective of the audit is to ascertain that the business partner is ensuring Pharmacovigilance compliance in-line with the SDEA.

Scope

The scope, by and large, depends upon the type of business partner relationship. The scope includes, although is not limited to,

1. SDEA Completeness: Availability of all relevant clauses with well-defined responsibility sharing, Validity and most importantly, the inclusion of correct contact details as well as product list

2. Training: Pharmacovigilance personnel as well as other allied staff

3. RSI Maintenance, including CCDS (where applicable)

4. ICSR Exchange (including format – source docs/XML/CIOMS/Gateway transmission etc) and reconciliation

5. Global Safety Database Ownership

6. Aggregate Safety Reporting, Signal Management and RMP

7. PSMF

8. Local QPPV

9. Periodic Review of SDEA

10. QMS and BCP

Type of Audit: It is advisable to perform at least a handful of on-site audits every year. The remote audit is also a viable option, especially in unforeseen circumstances and also based on the geographic location of a business partner.

Audit Findings: One should not forget to document the necessary information in the Annex G of PSMF and if required, in the body of PSMF.

Besides, Audit Findings and closure (at the appropriate time, based on response) would also provide some insights on when next to audit this partner. At times, companies may even consider termination of the contract. Let’s not forget that the regulatory agencies have the right to inspect the business partner. It is necessary to remember that the MAH is, at the end of the day, accountable for the outcome.