Pharmacovigilance in Saudi Arabia was established in 2005 by the Saudi Food and Drug Authority (SFDA). The first drafted document was about the initiation of the SFDA pharmacovigilance activities in the country. Thereafter, SFDA pharmacovigilance regulations rolled out continuously during the next few years, including the enforcement of the Qualified Person Responsible for Pharmacovigilance (QPPV) and publishing the SFDA Guideline on Good Pharmacovigilance Practices (GVP).
Now in 2021, the SFDA has reached an advanced level in the application of pharmacovigilance in Saudi Arabia. Enforcement of drug safety monitoring became more serious with regular inspections on pharmaceutical companies. They firmly check the integrity of the submitted Pharmacovigilance System Master File (PSMF), Pharmacovigilance Sub-System File (PSSF), Risk Management Plan (RMP), and QPPV appointment among the drug registration requirements. In addition, SFDA is leading an initiative to encourage health care practitioners and patients to report adverse drug reactions (ADRs).
For those who wonder, what is Pharmacovigilance?, it is defined as “The science and activities relating to the detection, assessment, understanding, and prevention of adverse effects or any other drug-related problem.”WHO
SFDA Pharmacovigilance Regulation
After a few announcements and draft documents, the official pharmacovigilance enforcement in Saudi took place as follows:
- In 2009, an SFDA circular was issued requesting the industry to submit the aggregate adverse reaction reports (PSURs) 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.
- In November 2010, an SFDA circular was issued marking the first enforcement of QPPV on the pharmaceutical industry.
- In October 2014, a circular was issued mandating the Saudization of the QPPV role (to be a job for Saudi nationals only). The circular determined the end of 2016 as the deadline for enforcement.
SFDA Pharmacovigilance Guidelines
The first official version of the SFDA GVP guideline was issued in 2015 under the name “Guideline on Good Pharmacovigilance Practices (GVP). The former name for this guideline was (Saudi Pharmacovigilance Guideline of Registered Medicines) published in June 2011.
The first official SFDA Pharmacovigilance Guideline was issued in June 2011 under the name (Saudi Pharmacovigilance Guideline of Registered Medicines). Thereafter, SFDA issued the new GVP guideline in 2015 under the name “Guideline on Good Pharmacovigilance Practices (GVP).
The Guideline on Good Pharmacovigilance Practices (GVP) was the first full PV reference. It is 499 pages adopted from the EU regulations. The SFDA took the enforcement slowly in a wise move to allow the appropriate understanding and absorption of the sudden heavy requirements and high overhead cost on the industry.
In this GVP guidelines, the SFDA describes their requirements in each major pharmacovigilance process (Eleven Pharmacovigilance Modules). They are generally adopted from the EU 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).”
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.
Requirements of Pharmacovigilance in Saudi Arabia
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 QPPV, controlled by a quality system, and documented in special format files (PSMF/PSSF).
We will summarize here the requirements according to the company type:
Local Saudi Distributor (Warehouse)
Since the ultimate pharmacovigilance responsibility is on the MA holder, the local distributors are not obliged to hire a QPPV nor implement a PV system. They need to be trained by the MAH on how to handle safety information, report ADRs, and other obligations covered by a safety data exchange agreement (SDEA).
The distributor in Saudi shall implement a full pharmacovigilance system only when they agree with the MAH to represent them for PV activities in Saudi. Therefore, distributors must be aware of PV articles in their commercial or technical agreements since it will impose compliance obligations that are of high cost and complexity.
Saudi Pharmaceutical Manufacturer
When the manufacturer is the MAH, a PV system must be implemented and operated by a registered QPPV within the company. 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 develop and implement a local PV system in Saudi aside from the system applied in their home country or global office. 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 have a quality system in place that’s adequate for performing the pharmacovigilance activities. All operated by a dedicated employee with the title QPPV.
Without A Scientific Office
When the MAH is without any actual presence in Saudi as an entity, i.e. having a local distributor only, the MAH has two options:
- Agree with the distributor to cover their pharmacovigilance obligation.
- Outsourced to a third-party QPPV that is license by SFDA as a pharmacovigilance service provider.
Pharmaceutical companies can contract with a pharmacovigilance consulting service to cover the QPPV and the other requirements of Pharmacovigilance in Saudi Arabia. Putsourcing PV & QPPV to a third party acknowledges and accepted by the authority as stipulated in the SFDA pharmacovigilance guidelines. The consultancy must be licensed by the SFDA with one or more registered QPPVs.
Submission of Pharmacovigilance files
The MAH must submit its local system in the form of a pharmacovigilance system master file (PSMF) along with a product-specific risk management plan (RMP) during the drug registration. Besides, a Pharmacovigilance Sub-System File (PSSF) is required when the MAH is a foreign entity. According to GVP guidelines, the PSSF must be provided within the first application ever submitted to the SFDA. All that to accompany an appointment of a QPPV and a deputy QPPV in the registration file within module 1.
Qualified Person Responsible for Pharmacovigilance
As part of the pharmacovigilance system, the MAH must appoint a full-time qualified person responsible for pharmacovigilance (QPPV), SFDA GVP Guidelines I.C.1.1. The MAH is optioned to either hire its own independent employee, or appoint the local distributor’s QPPV (if available and reliable), or contract with a third-party outsourced QPPV. The appointment of a QPPV entails a deputy QPPV to work as a backup in the absence of the QPPV.
The MAH must ensure that the QPPV has sufficient knowledge, training, experience, and qualifications for the performance of pharmacovigilance activities. The QPPVs should meet the minimum requirements as below:
QPPV Certifications and Qualifications
The SFDA has determined certain certifications and qualification for the QPPV to operate in Saudi Arabia that are enforced through the GVP guidelines and related PV circulars. The certificates and qualifications needed are:
- Bachelor’s degree in pharmacy or medicine
- Basic training in epidemiology and biostatistics
- Licensed by Saudi Commission for Health Specialties (SCFHS).
- Have the skill for the management of pharmacovigilance systems
- Have experience or access to expertise in medicine, pharmaceutical science, epidemiology, and biostatistics.
QPPV Conditions in Saudi Arabia:
- Full-time employee or contracted QPPV (third party/PV service).
- 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 would include:
- Promote, maintain and improve compliance with the legal pharmacovigilance requirements.
- Oversight over the functioning of the company’s quality system, such as standard operating procedures SOPs, CAPAs, documents control, etc.
- Ensuring 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
- Creation and maintenance of 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;
- Ensuring conduct of 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 drugs safety profiles
- To have an awareness 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 to 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 preparation of the regulatory actions in case of emerging safety concerns.
- Access and receives 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; and
- Other MAH procedures relevant to the pharmacovigilance system aimed to maintain consistent and compliant organization.
- To be aware of the results and the measures resulted by the frequent review of the quality system.
- To have visibility on compliance information to assure commitments.
- To receive information about scheduled audits and able 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 in acquisitions, the QPPV needs to be aware the soonest to assess potential risks on the pharmacovigilance system.
- To review and approve contract sections related to pharmacovigilance and exchange of safety data.
- In cases of new partnerships with other MAH or third parties, QPPV should be aware as early as possible to review the need to receive their pharmacovigilance data, add parts in the contractual agreement, or establish pharmacovigilance agreements.