Create a National Control Agency
This section deals with providing advice and training to Governments on establishing a National Control Agency (NCA) for regulation of vaccines and other biologics which meet WHO requirements and regulations.
This advice and training to Governments is broken down into 7 areas: Legal establishment of NCA to regulate vaccines, Licensing Process, Surveillance of vaccine field performance, Lot Release, Laboratory Access, GMP inspections, and Clinical evaluation of safety and efficacy. Click on the appropriate heading above or return to the home page.
Legal establishment of NCA to regulate vaccines
- Legislative basis for establishment of vaccine regulatory enforcement
- Independence of regulatory authority from manufacturer and indicated lines of authority
- Criteria for recognition of other regulatory authorities
- Recall system
- Written guidelines for destruction of lots and documentation
- Appropriate expertise of staff
- Institutional development plan
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Licensing Process
- License of both facilities and products
- Equality of process for both imported and locally produced vaccines
- Written guidelines for submission of the file
- Written guidelines for GMP assessment
- Written guidelines for review of licence application
- Written procedures for waiver of steps
- Written guidelines for variance to license
- Selection and use of expert committees
- NCA works with manufacturer prior to submission
- List of licensed products and manufacturers
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Surveillance of vaccine field performance
- Written guidelines and implementation of a system for detection and investigation of adverse events following immunization
- List of adverse events to monitor
- Surveillance for impact of vaccine on disease incidence
- Provision to accumulate surveillance data for regulatory review and action
- Possibility of including mandatory post-marketing monitoring in license
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Lot Release
- Based at minimum on protocol review (need obligatory summary lot protocol as part of specification for procurement)
- Written procedure for lot release process (check list, guidelines, study plan, sampling)
- Access to product file and inspection reports, complaints
- Records kept of lot release data for trend analyses
- Written criteria for exemption from lot release
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Laboratory Access
- Support for a laboratory quality system from management
- Designation of a person responsible for laboratory quality systems
- Existence of a quality manual
- Documentation of procedures in place (including document control, SOP’s, study plan for control of specific products, retest policy)
- Equipment documentation in place
- Staff training plan developed and implemented
- Existence of an audit and review system
- Validation procedures in place for all tests
- Existence of a general safety program
- Appropriate use of standards and reference reagents
- Monitoring and analysis of data trends on a product by product basis
- Participation in proficiency testing schemes and collaborative studies
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GMP inspections
- Written requirements or codes consistent with WHO GMP requirements
- Provision for acceptance and issuance of GMP certificates
- Evidence of enforcement of GMP in production facilities
- Written plan for inspection
- Qualification for inspectors
- Timetable for inspection
- Defined actions following inspection
- Inspectors independent of the manufacturer
- Inspection team contains biologics experts
- Established procedure to monitor inspection process
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Clinical evaluation of safety and efficacy
- Policy of GMP, GLP, GCP, ethical oversight of trials
- Written guidelines for when clinical trials will be needed
- Published guidelines on the format for submission of clinical data
- Expertise in epidemiology and statistics to advise on set up of and analysis of trials
- Access to experts in the product being tested
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