Voluntary admissions to the PMCPA by companies undergoing audit
The definition and basis of self-regulation requires pharma companies to have in place processes to detect issues and correct/prevent them in an appropriate, robust and timely manner…
_However, is there an expectation by the PMCPA that such issues form part of a voluntary admission? What turns a deviation into a voluntary admission? _ There appears to be a trend with companies who are being audited by the PMCPA to make voluntary admissions to them during this time or afterwards. Examples of such companies are listed below: Sanofi Sanofi Genzyme Astellas Sunovion (not yet published)
Understandably, during audit, companies that are under intense scrutiny look more closely and broadly at their material and activities. You might argue that they should have been doing this all along…** An effective compliance programme aims to identify and manage risk on a continuous basis, to improve adherence to business requirements.** The question of whether to submit a voluntary admission or not, is left to the discretion of individual companies.