Regulatory Consultant (Pharmacist BSc, Biomedical Informatics MSc). With 19 years of experience working for SFDA, multinational companies, and as a professional consultant.
This post will summarize the pharmacovigilance regulation in Saudi Arabia, including GVP guidelines, the appointment of a local QPPV (LQPPV), Individual case safety reports (ICSRs), and other related SFDA PV requirements. This will include a breakdown of the Pharmacovigilance responsibilities between different acting entities, such as distributors, scientific offices, local MAH, and global MAH. In addition, we will highlight the option to outsource the LQPPV and related pharmacovigilance activities to a third party (Consultancy) to act on behalf of the MAH in the Saudi market.
2005 The SFDA released the first draft of the pharmacovigilance guidelines.
2009 An SFDA circular was issued requesting the industry to submit the aggregate adverse reaction (ADR) reports to The National Pharmacovigilance and Drug Safety Center, currently named (Saudi Vigilance). This SFDA circular was the first direct enforcement of PV in Saudi Arabia.
2010 SFDA issued a circular marking the first enforcement of the need to appoint a QPPV/LQPPV.
2011 The first official SFDA PV Guideline was issued in June 2011 under the name (Saudi Pharmacovigilance Guideline of Registered Medicines).
2014 SFDA issued a circular mandating the Saudization of the QPPV role (for Saudi nationals only). The circular specified the end of 2016 as the deadline for enforcement.
2015 SFDA issued the PV guidelines under the new title: Guideline on Good Pharmacovigilance Practices (GVP). This version was the first comprehensive PV reference that came in 499 pages. However, the SFDA wisely applied gradual enforcement to allow sufficient time for the local industry to implement such heavy requirements and plan for their related costs. The GVP guideline describes the requirements in each significant PV process within eleven PV modules. They are generally adopted from the EU guidelines but with Saudi-specific requirements. For example, the SFDA requests all international marketing authorization holders (MAHs) to develop and maintain a local PV system in Saudi Arabia. It has to be documented in a file called “Pharmacovigilance Sub-System File (PSSF),” which is needed besides the company’s global PV system “Pharmacovigilance System Master File (PSMF).”
2023 The SFDA reached an advanced level in implementing the PV guidelines. Enforcement became more stringent with regular inspections of pharmaceutical companies. SFDA firmly checks the integrity of the submitted PSMF, PSSF, Risk Management Plan (RMP), and QPPV appointment within the drug registration application. In addition, SFDA is leading a countrywide initiative to encourage healthcare practitioners and patients to report adverse drug reactions (ADRs).
2024 Submission of Risk Minimization Measures (RMMs) and proof of the distribution efficacy is growing requested by SFDA.
Pharmacovigilance Activities
What is meant by pharmacovigilance activities is the process of collection and assessment of safety data, mostly adverse drug events, originating from solicited or spontaneous sources. The whole activity is designed to achieve one objection: to increase the benefit-risk profile of a drug product.
Pharmacovigilance Requirements
According to the SFDA GVP guidelines, the marketing authorization holder (MAH) is responsible for implementing a compliant PV system. It shall be operated by a local QPPV within a quality system and documented in a local PSMF called PSSF.
We will summarize here the requirements according to the company type:
Local Distributor
Since the MA holder is ultimately responsible for PV, local Saudi distributors are not obliged to hire a QPPV or implement a PV system. Distributors must only be trained by the MAH to handle safety information, report ADRs, and fulfil other PV obligations under a safety data exchange agreement (SDEA).
However, if the Distributor agrees to cover the PV responsibility on behalf of the MAH, they shall hire an LQPPV and implement a complete PV system. They can also outsource it to a PV service provider.
Saudi Pharmaceutical Manufacturer
When the Saudi manufacturer is also the MAH for a product, they must implement, operate, or outsource a PV system. The PV system represented in the PSMF is sufficient for local Pharmaceutical manufacturers.
International Pharmaceutical Company
With a Scientific Office
Foreign pharmaceutical companies with registered scientific offices must implement a local PV system in Saudi Arabia (PSSF) in addition to the one implemented in their global offices PSMF. The local PV system shall cover all PV tasks and responsibilities inside the Saudi market to assure their liability for the safety of their registered drugs.
In addition, the MAH must establish an adequate quality management system (QMS) for performing PV activities. The scientific office can also outsource PV activities to a consultancy office.
Without a Scientific Office
When the MAH has no Saudi-based office (only a local distributor), then it has two options to cover the QPPV obligation:
Local Distributor The MAH agrees with the Distributor to cover the PV obligations on their behalf through their registered QPPV. This is a feasible option when the PV function at the local Distributor is professional and can meet the SFDA and the PV global office requirements.
Pharmacovigilance Vendor To outsource the PV role to an SFDA-licensed pharmacovigilance service provider. This option is the most preferred option for multinational companies.
Pharmacovigilance Consultancy
Pharmaceutical companies have the option to contract with PV / QPPV service providers. The SFDA accepts contracting with a Pharmacovigilance consultancy office, as stipulated in the SFDA GVP guidelines.
Submission of PV files
In the drug registration application (module 1- eCTD), the MAH must submit the following:
PV system
PSSF Applicable to multinational MAH companies. According to GVP guidelines, the PSSF must be submitted to the SFDA within the first application.
QPPV and a deputy QPPV appointment files.
RMP & RMM, if any.
Qualified Person Responsible for Pharmacovigilance (QPPV)
As part of the PV system, the MAH must appoint a full-time local qualified person responsible for pharmacovigilance (QPPV) and a deputy QPPV to work as a backup.
The MAH can hire an independent employee (Saudi Pharmacist) or contract with a pharmacovigilance consultancy. The MAH must ensure that the QPPV has sufficient knowledge, training, experience, and qualifications to perform PV activities.
The QPPV must meet the minimum requirements as below:
QPPV Requirements
The SFDA specified QPPV requirements that they must carry to be accepted. They are the following certifications and qualifications:
Bachelor’s degree in pharmacy or medicine
Licensed by the Saudi Commission for Health Specialties (SCFHS).
Have the skill for the management of PV systems
Basic training in epidemiology and biostatistics
Have experience or access to expertise in medicine, pharmaceutical science, epidemiology, and biostatistics.
QPPV Conditions
Full-time employee or outsourced.
Available permanently and continuously
Resides in Saudi Arabia
Saudi Nationality
QPPV Responsibilities in Saudi Arabia
The SFDA pharmacovigilance guidelines stipulate that the QPPV shall be responsible for establishing and maintaining the pharmacovigilance system. This includes:
Promote, maintain and improve compliance with the legal pharmacovigilance requirements.
Supervise PV-related quality system files, such as standard operating procedures (SOPs), CAPAs, etc.
Proper conduct of pharmacovigilance activities.
The sole PV contact point on a 24-hour basis
Pharmacovigilance inspections.
SDEAs: development and maintenance.
PV Safety Database Operations
ADRs reporting quality, completeness, and timeliness
Submission of Periodic Safety Update Report (PSUR)
Annual PV refresher training
PSMF: development and maintenance.
PSSF: development and maintenance.
Submission to SFDA with necessary quality, correctness, and completeness of data.
Respond to SFDA inquiries.
Oversee and provide input into the regulatory action plans in response to emerging safety concerns such as recalls, urgent safety updates, variations, and communication to patients and healthcare professionals (DHCPs)
Overview of the drug safety profiles
Aware of any conditions and obligations committed to the SFDA
Aware of and with authority over the content of RMP RMMs
Review and approve the protocols of post-authorization safety studies (PASS) conducted in Saudi
Validation of PV software
Audits: periodic internal and external with archiving of its reports.
QPPV Authority in the Organization
The MAH must provide the QPPV with enough authority to:
Control over the local PV activities.
Control over the PV quality system
Access to the PSMF
Implement changes to the PV system.
Influence RMPs
Add input to the regulatory actions in case of emerging safety concerns.
Access and receive all relevant information, specifically those related to:
Clinical trials and studies related to the safety of the drug.
Information from other sources, such as contractual arrangements
Other MAH procedures relevant to the PV system aimed at maintaining consistent and compliant organization.
To be aware of the results and the applied measures resulting from the review of the quality system.
To have visibility on compliance information to assure commitments.
To receive information about scheduled audits and to initiate new ones.
To have access to the corrective and preventive plans related to PV.
To have access to the adverse reactions database.
In cases of new additions to the MAH products portfolio, such as acquisitions, the QPPV needs to assess potential risks to the PV system.
To review and approve contract sections related to PV and exchange of safety data.
In new partnerships with other MAH or Pharmacovigilance consultancy, the QPPV should be notified to review their PV data, add parts to the contractual agreement, or establish PV agreements.
FAQs
When must A QPPV be appointed?
The QPPV must be registered in Saudi SFDA before the product is registered. If the SFDA detects a lack of appointed QPPV for the product during drug registration, companies should expect a deficiency inquiry asking for proof of appointment.
Does SFDA accept third-party QPPV (outsourced)?
In Saudi Arabia, SFDA GVP guidelines allow partial or complete outsourcing of PV activities, including QPPV or partial activities like literature reviews. However, QPPV or LQPPV must be located in Saudi Arabia.
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Regulatory Consultant (Pharmacist BSc, Biomedical Informatics MSc). With 19 years of experience working for SFDA, multinational companies, and as a professional consultant.
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