How to Register Herbal Products in Pakistan?

Legal Framework for Herbal Product Registration Process

The registration of herbal products in Pakistan is governed by the Drug Regulatory Authority of Pakistan (DRAP) Act, 2012. This legislation provides the legal framework for the regulation, manufacture, import, export, storage, distribution, and sale of therapeutic goods, including herbal medicines. The DRAP Act empowers the authority to establish guidelines and procedures for product registration, quality control, and safety monitoring.

Under the DRAP Act, herbal products are classified as “alternative medicines” and are subject to specific regulations outlined in the Alternative Medicines and Health Products (Enlistment) Rules, 2014. These rules define the requirements for product registration, manufacturing standards, and quality control measures. Compliance with these regulations is mandatory for all businesses seeking to register and market herbal products in Pakistan.

The legal framework also incorporates international standards and guidelines, such as those set by the World Health Organization (WHO) for traditional and complementary medicines. This alignment ensures that Pakistani herbal products meet global quality and safety standards, facilitating potential export opportunities.

Documentation Required for Product Registration Application Steps

The product registration application process for herbal products in Pakistan requires comprehensive documentation. Applicants must submit the following:

1. Completed application form (Form-5) as prescribed by DRAP
2. Product dossier containing detailed information on:
   • Composition and formulation
   • Manufacturing process
   • Quality control methods
   • Stability data
   • Safety and efficacy data
3. Good Manufacturing Practice (GMP) certificate for the manufacturing facility
4. Certificate of Analysis (CoA) for the finished product
5. Product samples for laboratory testing
6. Proposed packaging and labeling designs
7. Literature references supporting the product’s traditional use and safety
8. Legal documents, including company registration certificate and manufacturing license

The application process involves several steps:

1. Submission of the application and required documents to DRAP
2. Initial screening for completeness
3. Technical evaluation by expert committees
4. Laboratory testing of product samples
5. Inspection of manufacturing facilities
6. Final review and decision by the Registration Board

Applicants should ensure all documentation is accurate, up-to-date, and complies with DRAP’s guidelines to avoid delays in the registration process.

Quality Control and Testing Requirements Documentation Guide

Quality control and testing are critical aspects of herbal product registration in Pakistan. DRAP mandates strict adherence to quality standards to ensure product safety and efficacy. The quality control documentation must include:

1. Detailed specifications for raw materials and finished products
2. Standard operating procedures (SOPs) for manufacturing processes
3. In-process quality control measures
4. Finished product testing protocols
5. Stability testing data and protocols
6. Analytical method validation reports

Testing requirements for herbal products include:

1. Identity tests to confirm the presence of declared herbs
2. Purity tests to detect contaminants and adulterants
3. Microbial limit tests to ensure product safety
4. Heavy metal analysis to check for toxic elements
5. Pesticide residue analysis
6. Aflatoxin testing for products prone to fungal contamination

Manufacturers must establish and maintain a quality management system that ensures consistent product quality. This system should be documented and include procedures for:

1. Raw material testing and approval
2. Batch manufacturing records
3. Equipment calibration and maintenance
4. Personnel training and qualification
5. Product release criteria
6. Handling of out-of-specification results

DRAP may conduct periodic inspections of manufacturing facilities to verify compliance with quality control requirements. Manufacturers should maintain comprehensive documentation of all quality control activities to facilitate these inspections and demonstrate ongoing compliance.

DRAP Compliance and Registration Process Implementation Steps

Implementing DRAP compliance and successfully navigating the registration process involves several key steps:

1. Familiarization with Regulations:
   • Study the DRAP Act, 2012, and relevant rules and guidelines
   • Attend DRAP-organized workshops and seminars on regulatory compliance
2. Facility Preparation:
   • Establish a GMP-compliant manufacturing facility
   • Implement quality management systems
   • Train staff on regulatory requirements and GMP principles
3. Product Development:
   • Formulate products in compliance with DRAP guidelines
   • Conduct necessary safety and stability studies
   • Prepare comprehensive product dossiers
4. Application Submission:
   • Complete Form-5 and gather all required documentation
   • Submit the application package to DRAP
   • Pay the prescribed registration fees
5. Application Follow-up:
   • Respond promptly to any queries or requests for additional information from DRAP
   • Facilitate facility inspections by DRAP officials
   • Provide product samples for laboratory testing as required
6. Post-Registration Compliance:
   • Implement pharmacovigilance systems for adverse event reporting
   • Maintain ongoing compliance with GMP and quality control requirements
   • Submit periodic safety update reports to DRAP
7. Continuous Improvement:
   • Stay updated on regulatory changes and new guidelines
   • Regularly review and update internal processes to ensure ongoing compliance

Successful implementation of these steps requires a dedicated regulatory affairs team or consultant familiar with DRAP requirements and procedures. This ensures smooth navigation of the registration process and maintains ongoing compliance with regulatory standards.

Manufacturing Facility Requirements and Guidelines Documentation

Manufacturing facilities for herbal products in Pakistan must comply with Good Manufacturing Practice (GMP) guidelines as outlined by DRAP. The facility requirements and guidelines documentation should include:

1. Facility Layout and Design:
   • Detailed floor plans showing production areas, storage spaces, and quality control laboratories
   • Air handling and water systems specifications
   • Pest control measures
2. Equipment Specifications:
   • List of manufacturing equipment with technical specifications
   • Calibration and maintenance schedules
   • Standard operating procedures for equipment use and cleaning
3. Personnel Requirements:
   • Organizational chart with clearly defined roles and responsibilities
   • Qualification and training records for key personnel
   • Health and hygiene policies for staff
4. Production Processes:
   • Detailed manufacturing procedures for each product
   • In-process control measures
   • Batch manufacturing and packaging records templates
5. Quality Control:
   • Laboratory equipment specifications and maintenance records
   • Testing procedures for raw materials and finished products
   • Sample retention policies
6. Storage and Distribution:
   • Warehouse management procedures
   • Temperature and humidity monitoring systems
   • Transportation and logistics guidelines
7. Documentation System:
   • Document control procedures
   • Record-keeping policies and retention periods
   • Change control procedures
8. Validation:
   • Process validation protocols and reports
   • Cleaning validation documentation
   • Computer system validation (if applicable)
9. Safety and Environmental Compliance:
   • Waste management procedures
   • Occupational health and safety policies
   • Environmental impact assessment reports

Manufacturers should maintain comprehensive documentation of these aspects to demonstrate compliance with GMP requirements during DRAP inspections. Regular internal audits and updates to the documentation ensure ongoing adherence to regulatory standards and facilitate continuous improvement of manufacturing processes.

Product Labeling and Packaging Requirements Process Guide

Product labeling and packaging for herbal products in Pakistan must comply with DRAP regulations to ensure consumer safety and product integrity. The labeling and packaging process guide should include:

1. Label Content Requirements:
   • Product name and dosage form
   • List of active ingredients with quantities
   • Batch number and manufacturing date
   • Expiry date
   • Storage conditions
   • Manufacturer’s name and address
   • Registration number
   • Dosage instructions and indications
   • Warnings and contraindications
   • “For External Use Only” (if applicable)
2. Language Requirements:
   • Primary language: Urdu or English
   • Bilingual labeling (Urdu and English) for certain information
3. Packaging Specifications:
   • Primary packaging material specifications
   • Secondary packaging design and materials
   • Child-resistant packaging (if required)
   • Tamper-evident features
4. Artwork and Design:
   • Label layout and design templates
   • Color schemes and font specifications
   • Logo placement guidelines
5. Barcode and Serialization:
   • Implementation of track and trace systems (if required)
   • QR code inclusion for product authentication
6. Leaflet/Insert Requirements:
   • Detailed product information
   • Usage instructions
   • Side effects and precautions
   • Storage and handling guidelines
7. Approval Process:
   • Internal review and approval procedures
   • Submission of packaging mockups to DRAP for approval
   • Revision and resubmission process (if needed)
8. Quality Control:
   • Label and packaging material inspection procedures
   • Printing quality checks
   • Reconciliation of packaging materials
9. Compliance Monitoring:
   • Regular review of labeling and packaging against current regulations
   • Update procedures for regulatory changes

Manufacturers should establish a robust system for managing labeling and packaging processes, ensuring all products comply with DRAP requirements. Regular training for staff involved in packaging and labeling operations is essential to maintain compliance and prevent errors.

Raw Material Sourcing and Documentation Requirements Steps

Proper sourcing and documentation of raw materials are crucial for ensuring the quality and safety of herbal products. The steps for raw material sourcing and documentation include:

1. Supplier Qualification:
   • Develop criteria for supplier selection
   • Conduct supplier audits and evaluations
   • Maintain an approved supplier list
2. Raw Material Specifications:
   • Establish detailed specifications for each raw material
   • Include botanical identification, chemical composition, and purity standards
   • Define acceptable limits for contaminants and adulterants
3. Purchasing Process:
   • Create standard operating procedures for raw material procurement
   • Implement a system for purchase order generation and approval
   • Establish communication channels with suppliers
4. Receipt and Inspection:
   • Develop procedures for receiving and inspecting incoming materials
   • Implement a quarantine system for materials pending quality control approval
   • Conduct identity tests on all incoming herbal materials
5. Documentation Requirements:
   • Obtain certificates of analysis (CoA) from suppliers for each batch
   • Collect botanical certificates of authenticity for herbal ingredients
   • Maintain records of raw material origin and traceability
6. Quality Control Testing:
   • Establish protocols for in-house testing of raw materials
   • Define sampling procedures and retention sample policies
   • Maintain records of all quality control test results
7. Storage and Handling:
   • Implement proper storage conditions for different types of raw materials
   • Establish inventory management and stock rotation procedures
   • Maintain temperature and humidity monitoring records
8. Supplier Performance Monitoring:
   • Develop a system for tracking supplier performance
   • Conduct periodic supplier re-evaluations
   • Maintain records of supplier communications and corrective actions
9. Documentation Management:
   • Establish a document control system for all raw material-related records
   • Ensure proper retention and retrieval of documentation
   • Implement a change control process for raw material specifications
10. Regulatory Compliance:
    • Ensure all raw materials comply with DRAP regulations and guidelines
    • Maintain up-to-date information on regulatory requirements for herbal ingredients
    • Implement procedures for handling non-conforming materials

By following these steps and maintaining comprehensive documentation, manufacturers can ensure the quality and regulatory compliance of their raw materials, which is essential for the production of safe and effective herbal products.

Safety Testing and Clinical Trial Documentation Process

Safety testing and clinical trials for herbal products in Pakistan require thorough documentation to demonstrate product safety and efficacy. The process includes:

1. Pre-clinical Safety Assessment:
   • Literature review of traditional use and known safety profile
   • Toxicological studies (acute, sub-chronic, and chronic toxicity)
   • Genotoxicity and mutagenicity studies
   • Reproductive toxicity studies (if applicable)
2. Clinical Trial Planning:
   • Development of clinical trial protocols
   • Ethical committee approval documentation
   • DRAP approval for conducting clinical trials
3. Clinical Trial Phases:
   • Phase I: Safety and tolerability studies
   • Phase II: Efficacy and dose-finding studies
   • Phase III: Large-scale efficacy and safety studies
   • Phase IV: Post-marketing surveillance studies
4. Documentation Requirements:
   • Investigator’s brochure
   • Case report forms (CRFs)
   • Informed consent forms
   • Adverse event reporting forms
   • Data management and statistical analysis plans
5. Clinical Trial Conduct:
   • Site selection and qualification documentation
   • Investigator and staff training records
   • Patient recruitment and screening logs
   • Drug accountability records
   • Monitoring visit reports
6. Data Collection and Management:
   • Electronic data capture system validation
   • Data entry and verification procedures
   • Query resolution documentation
   • Database lock procedures
7. Safety Monitoring:
   • Adverse event reporting and follow-up documentation
   • Safety review committee meeting minutes
   • Periodic safety update reports
8. Clinical Study Report:
   • Comprehensive report of study design, methods, results, and conclusions
   • Statistical analysis outputs
   • Individual patient data listings
9. Regulatory Submission:
   • Compilation of clinical trial data for DRAP submission
   • Responses to regulatory queries and information requests
   • Post-approval safety monitoring plans
10. Record Retention:
    • Archiving of essential documents as per DRAP requirements
    • Maintenance of trial master file
    • Long-term storage of biological samples (if applicable)

Manufacturers should ensure that all safety testing and clinical trial activities comply with Good Clinical Practice (GCP) guidelines and DRAP regulations. Proper documentation throughout the process is essential for regulatory approval and demonstrates the scientific validity of safety and efficacy claims for herbal products.

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Marketing Authorization Requirements Implementation Guide

Implementing marketing authorization requirements for herbal products in Pakistan involves several key steps:

1. Product Dossier Preparation:
   • Compile comprehensive product information
   • Include quality control data, stability studies, and safety information
   • Prepare detailed manufacturing process documentation
2. Application Submission:
   • Complete Form-5 as prescribed by DRAP
   • Submit the application along with the product dossier
   • Pay the required application fees
3. Technical Evaluation:
   • Respond to any queries from DRAP’s technical committees
   • Provide additional data or clarifications as requested
4. Product Samples:
   • Submit product samples for laboratory testing
   • Ensure samples meet all quality specifications
5. Manufacturing Facility Inspection:
   • Prepare for and facilitate DRAP inspection of manufacturing facilities
   • Address any observations or non-conformities identified during inspection
6. Labeling and Packaging Approval:
   • Submit proposed labeling and packaging designs for approval
   • Make necessary revisions based on DRAP feedback
7. Pharmacovigilance Plan:
   • Develop and submit a post-marketing surveillance plan
   • Establish systems for adverse event reporting and monitoring
8. Registration Certificate:
   • Obtain the registration certificate upon approval
   • Maintain records of registration details and validity period
9. Post-Registration Compliance:
   • Implement systems for ongoing compliance with registration conditions
   • Submit periodic safety update reports as required
10. Renewal Process:
    • Initiate renewal application before expiry of registration
    • Compile and submit data on post-marketing experience and any product changes

Manufacturers should establish a dedicated regulatory affairs team or engage consultants familiar with DRAP requirements to ensure smooth implementation of marketing authorization requirements. This approach facilitates efficient navigation of the regulatory process and maintains ongoing compliance with DRAP regulations.

Distribution Network Requirements Documentation Process Steps

Establishing and documenting a distribution network for herbal products in Pakistan involves several critical steps:

1. Distribution Strategy Development:
   • Define target markets and geographical coverage
   • Determine distribution channels (direct, wholesale, retail)
   • Establish distribution objectives and performance metrics
2. Distributor Selection:
   • Develop criteria for distributor qualification
   • Conduct due diligence on potential distributors
   • Evaluate distributor capabilities and infrastructure
3. Contractual Agreements:
   • Draft and execute distribution agreements
   • Define terms of sale, pricing structures, and payment terms
   • Outline responsibilities for product handling and storage
4. Licensing and Registration:
   • Ensure distributors have necessary licenses from provincial health authorities
   • Maintain records of distributor licenses and registrations
5. Product Knowledge Training:
   • Develop training materials on product features and benefits
   • Conduct training sessions for distributor staff
   • Maintain training records and competency assessments
6. Inventory Management:
   • Establish inventory control procedures
   • Implement stock rotation and expiry date tracking systems
   • Define minimum and maximum stock levels
7. Storage and Transportation:
   • Specify storage conditions for products (temperature, humidity)
   • Outline transportation requirements and cold chain management (if applicable)
   • Implement systems for monitoring and recording storage conditions
8. Quality Assurance:
   • Develop procedures for handling product complaints and recalls
   • Establish quality agreements with distributors
   • Conduct periodic audits of distributor facilities
9. Sales and Marketing Support:
   • Provide marketing materials and promotional support
   • Establish sales targets and incentive structures
   • Implement systems for sales reporting and performance tracking
10. Regulatory Compliance:
    • Ensure compliance with DRAP regulations on distribution practices
    • Maintain documentation of product traceability throughout the supply chain
    • Implement systems for adverse event reporting and pharmacovigilance
11. Performance Monitoring:
    • Establish key performance indicators (KPIs) for distributors
    • Conduct regular performance reviews
    • Implement corrective action plans for underperforming distributors
12. Documentation Management:
    • Maintain comprehensive records of all distribution-related activities
    • Implement a document control system for distribution network documentation
    • Ensure proper retention and retrieval of distribution records

By following these steps and maintaining thorough documentation, manufacturers can establish a compliant and efficient distribution network for their herbal products in Pakistan. This process ensures product quality and integrity throughout the supply chain and facilitates regulatory compliance.

Staff Training and Qualification Requirements Guide

Ensuring proper staff training and qualifications is essential for maintaining regulatory compliance and product quality in the herbal products industry. The following guide outlines key aspects of staff training and qualification requirements:

1. Training Program Development:
   • Create a comprehensive training curriculum covering GMP, quality control, and regulatory compliance
   • Develop role-specific training modules for different departments
   • Establish a training schedule and frequency for refresher courses
2. Qualification Requirements:
   • Define minimum educational and experience requirements for each position
   • Establish job descriptions with clearly outlined responsibilities
   • Implement a system for verifying staff credentials and qualifications
3. Induction Training:
   • Develop an orientation program for new employees
   • Cover company policies, safety procedures, and basic GMP principles
   • Provide an overview of the herbal product industry and regulatory landscape
4. GMP Training:
   • Conduct regular GMP training sessions for all staff involved in manufacturing
   • Cover topics such as personal hygiene, documentation practices, and contamination prevention
   • Implement practical training on GMP implementation in daily operations
5. Quality Control Training:
   • Provide specialized training for quality control personnel
   • Cover analytical techniques, equipment operation, and data interpretation
   • Include training on handling out-of-specification results and conducting investigations
6. Regulatory Compliance Training:
   • Offer training on DRAP regulations and guidelines
   • Cover product registration requirements and post-marketing obligations
   • Provide updates on changes in regulatory requirements
7. Documentation and Record-Keeping:
   • Train staff on proper documentation practices
   • Implement systems for maintaining training records
   • Establish procedures for documenting on-the-job training and competency assessments
8. Continuous Education:
   • Encourage staff participation in external workshops and seminars
   • Provide opportunities for advanced certifications and qualifications
   • Implement a system for knowledge sharing within the organization
9. Performance Evaluation:
   • Conduct regular assessments of staff competency
   • Implement a system for identifying and addressing skill gaps
   • Provide feedback and develop individual improvement plans
10. Training Effectiveness Evaluation:
    • Assess the impact of training programs on job performance
    • Gather feedback from trainees and supervisors
    • Continuously improve training materials and methodologies based on evaluations
11. Compliance Monitoring:
    • Conduct internal audits to ensure adherence to training requirements
    • Maintain up-to-date training matrices for all staff
    • Implement corrective actions for any identified non-conformities in training practices

By implementing a comprehensive staff training and qualification program, manufacturers can ensure that their workforce is competent, compliant with regulatory requirements, and capable of producing high-quality herbal products. This approach not only supports regulatory compliance but also contributes to overall operational excellence and product safety.

Product Storage and Handling Guidelines Implementation

Implementing proper product storage and handling guidelines is crucial for maintaining the quality and safety of herbal products. The following steps outline the implementation process:

1. Storage Area Design:
   • Designate separate areas for raw materials, in-process products, and finished goods
   • Implement temperature and humidity control systems
   • Install proper lighting and ventilation
2. Storage Conditions:
   • Define specific storage requirements for each product (temperature, humidity, light exposure)
   • Implement monitoring systems for environmental conditions
   • Establish procedures for handling temperature-sensitive products
3. Inventory Management:
   • Implement a First-Expiry-First-Out (FEFO) system
   • Establish procedures for stock rotation and expiry date tracking
   • Develop a system for quarantine of rejected or returned products
4. Handling Procedures:
   • Create SOPs for product handling, including receiving, storage, and dispatch
   • Train staff on proper handling techniques to prevent contamination or damage
   • Implement hygiene protocols for personnel working in storage areas
5. Documentation:
   • Develop and maintain batch records for all stored products
   • Implement a system for recording environmental monitoring data
   • Establish procedures for documenting product movement and stock levels
6. Quality Control:
   • Implement regular quality checks on stored products
   • Establish procedures for handling out-of-specification products
   • Develop a system for product release and recall
7. Security Measures:
   • Implement access control systems for storage areas
   • Establish procedures for preventing theft and unauthorized access
   • Develop a system for tracking and investigating any discrepancies in inventory
8. Transportation:
   • Define requirements for product transportation, including temperature control
   • Establish procedures for verifying transport conditions
   • Implement systems for tracking product shipments
9. Staff Training:
   • Provide comprehensive training on storage and handling procedures
   • Conduct regular refresher training sessions
   • Implement competency assessments for staff involved in storage and handling
10. Compliance Monitoring:
    • Conduct regular internal audits of storage and handling practices
    • Implement corrective and preventive action (CAPA) systems for addressing non-conformities
    • Ensure ongoing compliance with DRAP regulations on product storage and handling

By implementing these guidelines, manufacturers can ensure the integrity and quality of their herbal products throughout the storage and handling processes, thereby maintaining compliance with regulatory requirements and safeguarding product efficacy and safety.

Export Registration and Documentation Requirements Process

Exporting herbal products from Pakistan requires compliance with both domestic and international regulations. The process for export registration and documentation includes:

1. DRAP Export Registration:
   • Apply for export registration certificate from DRAP
   • Submit product dossier and manufacturing details
   • Obtain Good Manufacturing Practice (GMP) certificate
2. Product Documentation:
   • Prepare comprehensive product specifications
   • Compile stability data and shelf-life information
   • Develop Certificate of Analysis (CoA) for each batch
3. Quality Assurance:
   • Implement quality control measures for export batches
   • Conduct additional testing as per importing country requirements
   • Maintain batch manufacturing and testing records
4. Packaging and Labeling:
   • Design export-specific packaging and labeling
   • Ensure compliance with importing country regulations
   • Obtain approval for export packaging from DRAP
5. Export License:
   • Apply for export license from the Ministry of Commerce
   • Register with the Trade Development Authority of Pakistan (TDAP)
   • Obtain membership of relevant export association
6. Customs Documentation:
   • Prepare commercial invoice and packing list
   • Obtain Certificate of Origin from Chamber of Commerce
   • Arrange for pre-shipment inspection (if required)
7. Shipping Documentation:
   • Arrange for Bill of Lading or Airway Bill
   • Prepare shipping instructions and export declaration
   • Obtain insurance certificate for shipment
8. Importing Country Requirements:
   • Research and comply with regulatory requirements of the importing country
   • Obtain necessary product registrations or approvals
   • Prepare documentation specific to importing country regulations
9. Free Sale Certificate:
   • Apply for Free Sale Certificate from DRAP
   • Provide evidence of product registration and local sale
10. Halal Certification:
    • Obtain Halal certification (if required)
    • Ensure compliance with Islamic dietary laws
11. International Standards Compliance:
    • Implement and document compliance with international standards (e.g., WHO GMP)
    • Obtain relevant international certifications (e.g., ISO)
12. Record Keeping:
    • Maintain comprehensive records of all export-related documentation
    • Implement a system for easy retrieval and audit of export records

By following these steps and maintaining thorough documentation, herbal product manufacturers in Pakistan can effectively navigate the export registration process and meet the requirements for international trade. This process ensures compliance with both domestic and international regulations, facilitating smooth export operations and expanding market reach for Pakistani herbal products.

Regular Compliance and Monitoring System Implementation

Implementing a regular compliance and monitoring system is essential for maintaining regulatory adherence and product quality in the herbal products industry. The process involves:

1. Compliance Program Development:
   • Establish a comprehensive compliance policy
   • Define roles and responsibilities for compliance monitoring
   • Create a compliance calendar outlining periodic assessments and audits
2. Internal Audit System:
   • Develop an internal audit schedule covering all aspects of operations
   • Train internal auditors on GMP and regulatory requirements
   • Implement a system for documenting and tracking audit findings
3. Quality Management System:
   • Establish Standard Operating Procedures (SOPs) for all critical processes
   • Implement a document control system for managing SOPs and records
   • Develop a change control process for managing modifications to procedures
4. Regulatory Monitoring:
   • Assign responsibility for tracking regulatory updates from DRAP
   • Implement a system for disseminating regulatory information within the organization
   • Conduct periodic regulatory compliance assessments
5. Product Quality Monitoring:
   • Establish a system for ongoing stability testing of products
   • Implement in-process and finished product testing protocols
   • Develop procedures for handling out-of-specification results
6. Supplier Audits:
   • Establish a program for regular audits of raw material suppliers
   • Develop criteria for supplier qualification and performance evaluation
   • Maintain records of supplier audits and corrective actions
7. Training and Competency Assessment:
   • Implement a system for tracking employee training and qualifications
   • Conduct regular competency assessments for key personnel
   • Maintain up-to-date training records for all staff
8. Pharmacovigilance:
   • Establish a system for collecting and analyzing adverse event reports
   • Develop procedures for timely reporting of adverse events to DRAP
   • Conduct periodic safety reviews of marketed products
9. Data Integrity:
   • Implement measures to ensure the integrity of electronic data systems
   • Establish procedures for data backup and archiving
   • Conduct regular audits of data management practices