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.
The SFDA released the first draft of the pharmacovigilance guidelines.
An SFDA circular was issued requesting the industry to submit the aggregate adverse reaction reports (PSUR) to The National Pharmacovigilance and Drug Safety Center, currently named (Saudi Vigilance). This SFDA circular was the first direct enforcement of pharmacovigilance in Saudi Arabia.
SFDA issued a circular marking the first enforcement of the need to appoint a QPPV/LQPPV.
The first official SFDA Pharmacovigilance Guideline was issued in June 2011 under the name (Saudi Pharmacovigilance Guideline of Registered Medicines).
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.
SFDA issued the pharmacovigilance 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. Within eleven pharmacovigilance modules, the GVP guideline describes the requirements in each significant pharmacovigilance process. They are generally adopted from the EU guidelines but with Saudi-specific requirements. For example, the SFDA requests all international marketing authorization holders to develop and maintain a local pharmacovigilance 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).”
The SFDA reached an advanced level in the implementation of the pharmacovigilance system. The enforcement became more stringent with regular inspections of pharmaceutical companies. SFDA firmly checks the integrity of the submitted Pharmacovigilance System Master File (PSMF), Pharmacovigilance Sub-System File (PSSF), Risk Management Plan (RMP), and the 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).
The SFDA still requests an SDEA draft before accepting new local QPPV appointments. This is to check if the LQPPV will handle all mandatory activities in Saudi Arabia. In addition, we expect 2024 to be the year of RMMS and prove the efficacy of RMM distribution.
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.
According to the SFDA GVP guidelines, the marketing authorization holder (MAH) is responsible for implementing a compliant pharmacovigilance system. It shall be operated by a local QPPV within a quality system and documented in a local Pharmacovigilance System Master File (PSMF) or a local PSMF called a Pharmacovigilance Sub-System File (PSSF).
We will summarize here the requirements according to the company type:
Since the ultimate pharmacovigilance responsibility falls on the MA holder, the 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 other PV obligations under a safety data exchange agreement (SDEA).
However, if the Distributor agrees to cover the pharmacovigilance responsibility on behalf of the MAH, they shall hire an LQPPV and implement a complete pharmacovigilance system. They can also outsource it to a pharmacovigilance service provider.
Saudi Pharmaceutical Manufacturer
When the Saudi manufacturer is also the MAH for a product, they must implement and operate a PV system or outsource it. The PV system represented in the Pharmacovigilance System Master File (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). This is aside from 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 a quality management system (QMS) that is adequate for performing pharmacovigilance activities. The QPPV can operate PV & QMS both.
The Scientific office also has the option to outsource PV activities to a pharmacovigilance 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:
- Coverage by their local Distributor
The MAH agrees with the Distributor to cover the pharmacovigilance 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.
- Coverage by an outsourced QPPV (Pharmacovigilance Consulting)
To outsource the PV role to an SFDA-licensed pharmacovigilance service provider. This option is the most preferred option for multinational companies.
Pharmaceutical companies have the option to contract with PV / QPPV service providers. Contracting with a Pharmacovigilance consultancy office is accepted by the SFDA as stipulated in the SFDA GVP guidelines.
Submission of Pharmacovigilance files
In the drug registration application, the MAH must submit the following:
- Pharmacovigilance system
- Pharmacovigilance Sub-System File (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.
- Risk management plan (RMP).
- Risk Minimization Measures, if any.
Qualified Person Responsible for Pharmacovigilance (QPPV)
As part of the pharmacovigilance 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 its 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 pharmacovigilance activities.
The QPPV must meet the minimum requirements as below:
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 pharmacovigilance systems
- Basic training in epidemiology and biostatistics
- Have experience or access to expertise in medicine, pharmaceutical science, epidemiology, and biostatistics.
- 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 the functioning of the company’s quality system, such as standard operating procedures (SOPs), CAPAs, document control, etc.
- To ensure the proper conduct of pharmacovigilance activities.
- Acting as the sole pharmacovigilance contact point for the SFDA on a 24-hour basis
- Contact point for pharmacovigilance inspections.
- Establishment and maintenance of Saftey Data Exchange Agreements (SDEA)
- Safety Database operations
- ADRs reporting quality, completeness, and timeliness
- Submission of periodic update reports,
- Annual PV refresher training of company staff
- Creation and maintenance of the Pharmacovigilance system master file PSMF
- Create and maintain the Pharmacovigilance Sub-System File PSSF.
- Submission of all pharmacovigilance documents per SFDA GVP guidelines
- Respond to SFDA inquiries related to the benefit-risk evaluation of a medicinal product
- Ensuring the necessary quality, correctness, and completeness of data submitted to the SFDA;
- Conduct pharmacovigilance activities
- Oversee and provide input into the regulatory action plans in response to emerging safety concerns (e.g., variations, urgent safety updates, and communication to patients and healthcare professionals (DHCPs)
- To have an overview of the drug safety profiles
- To be aware of any conditions and obligations related to the products or committed to the SFDA at any stage.
- Aware of and with authority over the content of risk management plans;
- Aware of risk minimization measures;
- Review and approve the protocols of post-authorization safety studies (PASS) conducted in Saudi
- Aware of PASS requested by the SFDA
- Aware of the validation status of the adverse reaction database
- Periodic internal and external audits and archiving of its reports.
QPPV Authority in the Organization
The MAH must provide the QPPV with enough authority to:
- Control the quality system and the pharmacovigilance activities.
- Access the pharmacovigilance system master file (PSMF) with authority and be aware of any changes.
- Implement changes to the Pharmacovigilance system.
- Influence the risk management plans.
- Add input to the regulatory actions in case of emerging safety concerns.
- Access and receive all relevant information, specifically those related to:
- Emerging safety concerns, product benefit-risk evaluation.
- 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 pharmacovigilance system aimed to maintain consistent and compliant organization.
- To be aware of the results and the measures resulting from the frequent 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 pharmacovigilance system.
- To review and approve contract sections related to pharmacovigilance and exchange of safety data.
- In new partnerships with other MAH or Pharmacovigilance consultancy, the QPPV should be aware as early as possible to review the need to receive their pharmacovigilance data, add parts to the contractual agreement, or establish pharmacovigilance agreements.
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