PURPOSE
The scope describes the process to screen and assess new or updated Pharmacovigilance (PV), Clinical, and Regulatory Affairs (RA) regulatory policy documents on a regular basis for potential impact on company procedures, the documentation of the impact analysis, and the monitoring and completion of required implementation activities by XYZ Ltd.
RESPONSIBILITY
The Qualified Person for Pharmacovigilance/Deputy QPPV shall be responsible for Regulatory Intelligence activities that include four essential components: monitoring, analysis, reporting, and communications.
Introduction
Regulatory Intelligence is the act of gathering and analysing publicly available regulatory information. This includes communicating the implications of that information, and monitoring the current regulatory environment for opportunities to shape future regulations, guidance, policy, and legislation.
Regulatory Intelligence helps XYZ Ltd. anticipate and manage global regulatory developments in a single solution, removing the burden of having to manually track multiple sources of regulatory information from Primary research that covers data across country updates, regulatory updates, parliamentary coverage, trade association coverage, authority, ministry coverage, key opinion leaders and influencers.
Secondary research that encompasses data about country/product, regulatory landscape, clinical updates, and intelligence, news, and newsletters.
Regulatory Intelligence does not include;
- Competitive intelligence (sometimes done by the regulatory department, more often done by the marketing department)
- Proprietary information
- Sales or marketing information
- Drug pricing or insurance information
- Reimbursement issues.
Areas of interest that are screened in Regulatory Intelligence include many aspects of pharmacovigilance. They may include the need a range of requirements, such as:
- Individual Case Safety Reports (ICSR)
- Periodic Safety Update Reports (PSUR)
- Risk Management Plans (RMP)
- Pharmacovigilance System Master File (PSMF)
Sources of regulatory information;
- Pharmaceutical industry groups e.g. Kenya Association of Pharmaceutical Industry, Pharmaceutical Society of Kenya, Kenya Association of Pharmaceutical Manufacturers.
- Medical Literature and publications.
- Events data
- Insurance companies
- Health Authority websites
PROCEDURE
The QPPV/Deputy QPPV shall on the first five days of every month carry out regulatory intelligence activities by monitoring the health authority websites as per the regulatory intelligence data tracking sheet. This shall include to analyse each country unique requirements. Typical steps to achieve regulatory compliance include the following:
- Identify applicable regulations. Determine which laws and compliance regulations apply to the XYZ Ltd. and operations. These include National, State and Municipal rules.
- Determine requirements. Identify the requirements in each regulation that are relevant to XYZ Ltd., and consider plans on how to implement these mandates.
- Document compliance processes. Clearly document compliance processes, with specific instructions for each role involved in maintaining compliance. This information will be useful during regulatory audits.
- Monitor changes, and determine whether they apply. Compliance requirements are updated constantly. Changes to be monitored to determine if they are relevant to XYZ Ltd. If they are, the QPPV/Deputy QPPV shall implement updated procedures, and train the appropriate staff on these updates.
- A screen shot of the analysed health authority website shall be collected, printed and stored in the archives as part of proof that regulatory intelligence was conducted.
Communication
- The QPPV/Deputy QPPV shall be responsible for the communication of new/updated legislation/guidelines detected to management team on a monthly basis as per annexure 1 regulatory intelligence data collection form for update of new legislation/guidelines.
- For regulatory reporting purposes the clock starts (day zero) on the day when the journal is received/extracted from online sources by XYZ Ltd. The ICSR timelines for Serious ADR are 15 calendar day. Non-serious case shall be submitted alongside the scheduled PSUR for a particular product.
ANNEXURE
Annexure I: Databases and Product List Reconciliation form
ABBREVIATIONS
QPPV: Qualified Person for Pharmacovigilance
REVISION HISTORY
Nil
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