In April 2009, the TGA introduced an initiative that means sponsors of prescription medicine products may be required to submit a Risk Management Plan (RMP). This is a set of pharmacovigilance activities and interventions designed to identify, characterise and manage risks relating to a medicine. It should also contain the Detailed Description of the Pharmacovigilance System (DDPS), the framework for which is contained in Volume 9A of the EU guidelines, available here.
Independent of products and licences, the DDPS contains the definition of the working structures and processes a company has established for ensuring the safety of a medicine. This comprises, among other things, the areas of recording, processing and reporting suspected ADEs, compiling and reviewing PSURs, signal detection, and companies’ emergency procedures, databases, contractual arrangements, training and Quality Management Systems.
As per the TGA application process, CTD Module 1 will include Section 1.13.1 Risk Management Plan for Australia. A detailed description of a risk management system should be provided, where appropriate, in the form of a RMP, as outlined in Chapter 1.3 of EudraLex Volume 9A – Pharmacovigilance for Medicinal Products for Human Use (September 2008).
To avoid public scrutiny it is recommend that sponsors submit appropriate documentation of their Pharmacovigilance System. When dossier evaluation is published in form of AusPAR, there is a section titled ‘Pharmacovigilance’ that will contain the following information: pharmacovigilance system – comprising a statement about whether or not an applicant’s described pharmacovigilance systems meet TGA standards.
Even in the RMP evaluation phase, sponsors can be asked to provide details of the routine pharmacovigilance activities upon which they will rely to capture safety data. This means providing evidence that the proposed routine pharmacovigilance system is consistent with the activities outlined in 3.1.2 Routine Pharmacovigilance Activities (CPMP/ICH/5716/03).
Going further, the DPPS must also contain a description of the organisational structure. It should include names, locations and internal contact details for the parts of the company responsible for PV, as well as a brief description of the activities conducted in each location. There must be a section describing where the Australian office is located, its role and responsibility, and how it fits into the global pharmacovigilance function. The Australian Sponsor must also commission a Qualified Person for Pharmacovigilance (QPPV) to hold overall responsibility for the ensuing pharmacovigilance services and provide this person with the requisite resources. These details must also be included in the DPPS.
Keeping the standard
Standard Operating Procedures (SOPs) accompany the DDPS and must be listed. SOPs are binding global records a company uses to define its employees’ specific functions and tasks, as well as standardised processes. The sponsor must have a Quality Management System in place to prepare and update SOPs and manage the accompanying processes. A robust Pharmacovigilance System should have specific SOPs covering:
- QPPV activities (Australian, and EU where applicable) arrangements for an acting QPPV;
- collection and evaluation of Individual Case Safety Reports (ICSRs);
- follow-ups on ICSRs;
- reporting of 15-day ICSRs, compliance with deadlines;
- PSUR (preparation, quality control, submission);
- literature search
- general PV (signal detection, benefit/risk assessment, communication with authorities, healthcare professionals, etc. regarding safety related changes);
- dealing with safety risks resulting from product defects;
- working with databases;
- internal audits;
- training; and
For assistance with your Risk Management Plans and DPPS requirements, contact Commercial Eyes’ Medical Services team today on (03) 9251 0777.