SAQA All qualifications and part qualifications registered on the National Qualifications Framework are public property. Thus the only payment that can be made for them is for service and reproduction. It is illegal to sell this material for profit. If the material is reproduced or quoted, the South African Qualifications Authority (SAQA) should be acknowledged as the source.
SOUTH AFRICAN QUALIFICATIONS AUTHORITY 
REGISTERED QUALIFICATION: 

Higher Occupational Certificate: Health Products Regulatory Assistant (HPRA) 
SAQA QUAL ID QUALIFICATION TITLE
125140  Higher Occupational Certificate: Health Products Regulatory Assistant (HPRA) 
ORIGINATOR
Development Quality Partner - CHIETA 
PRIMARY OR DELEGATED QUALITY ASSURANCE FUNCTIONARY NQF SUB-FRAMEWORK
QCTO - Quality Council for Trades and Occupations  OQSF - Occupational Qualifications Sub-framework 
QUALIFICATION TYPE FIELD SUBFIELD
Higher Occupational Cert  Field 09 - Health Sciences and Social Services  Curative Health 
ABET BAND MINIMUM CREDITS PRE-2009 NQF LEVEL NQF LEVEL QUAL CLASS
Undefined  134  Not Applicable  NQF Level 05  Regular-ELOAC 
REGISTRATION STATUS SAQA DECISION NUMBER REGISTRATION START DATE REGISTRATION END DATE
Registered  EXCO 0936/25  2025-11-13  2029-11-13 
LAST DATE FOR ENROLMENT LAST DATE FOR ACHIEVEMENT
2030-11-13   2033-11-13  

In all of the tables in this document, both the pre-2009 NQF Level and the NQF Level is shown. In the text (purpose statements, qualification rules, etc), any references to NQF Levels are to the pre-2009 levels unless specifically stated otherwise.  

This qualification does not replace any other qualification and is not replaced by any other qualification. 

PURPOSE AND RATIONALE OF THE QUALIFICATION 
Purpose:
The purpose of Higher Occupational Certificate: Health Products Regulatory Assistant (HPRA) is to prepare a learner to function as a Health Products Regulatory Assistant (HPRA). A Health Products Regulatory Assistant (HPRA) prepares, collates and submits various applications for the registration of health products, for amendments/variations on registered health products and for the renewal of licences for health products, under the supervision of either a responsible pharmacist or authorised representative. Health products include medicines, medical devices and in vitro devices (IVDs), veterinary and personal care products. These applications are submitted to the regulatory body electronically in the main. A HPRA also conducts compliance activities to ensure that promotional material and activities meet the requirements of the legal framework. A HPRA assists with vigilance and post marketing surveillance of the health products.

A qualified learner will be able to:
  • Apply for licences for healthcare establishments and registration of health products.
  • Apply for renewals, amendments/ variations and retentions.
  • Conduct / perform code compliance activities on health products.
  • Conduct / perform vigilance and post marketing surveillance.

    Achieving this Health Products Regulatory Assistant (HPRA) qualification will provide several benefits to the learner, including:
  • Being able to carry out a range of regulatory-related activities for health products, including preparing, collating and submitting various applications for the registration and licensing of health products, amendments/variations to registered and licensed health products and licences for health products, conducting code compliance activities with respect to promotional material and activities, and conducting vigilance and post marketing surveillance of health products.
  • Acquiring in-depth knowledge of the health products regulatory requirements and related processes.
  • Taking a significant step into the health products sector with the prospect of acquiring higher qualifications in the field.
  • Acquisition of a formal qualification in health products regulatory environment if they do not already have a qualification.
  • Increasing the opportunity of gaining employment with companies that manage health product applications for registration and licensing. Considering South Africa's huge unemployment rate, a qualification like this has the potential to get learners into meaningful employment. This qualification will ensure the speedy registration and updating of health products, in companies getting their renewals for health products and in vigilance officers getting trained.

    Typical graduate attributes include proficiency, efficiency, and effectiveness in preparing dossiers for registration and renewal of health products. The Health Products Regulatory Assistant (HPRA) is a person of integrity and high ethical standards as they work within a regulatory framework to ensure the registration and licencing of health products that are safe to use.

    Rationale:
    No health product may be sold in South Africa unless it has been registered with an appropriate regulatory body. This qualification covers medicines, medical devices and In Vitro Devices (IVDs), complementary and over the counter (OTC) medicines, personal care products and veterinary products. Currently, the South African Health Products Authority (SAHPRA) registers health products as defined by the Medicines Act 101 of 1965 and its Amendments, whether they are manufactured locally or abroad, to ensure safety, efficacy, and quality

    According to the SAHPRA website, when a health product based on its category as defined by the Medicines Act 101 of 1965 and its Amendments, is first registered and made available in South Africa, information about its safety and effectiveness is usually only available from clinical trials. Clinical trials provide information about many of the possible adverse events associated with a health product prior to it being made available to the public, but these trials do not detect all possible adverse events until post marketing. SAHPRA monitors the safety of health products to contribute to a better understanding of their possible adverse events when they are used outside the controlled conditions of clinical trials.

    The Health Products Regulatory Assistant (HPRA) plays a critical role in assisting either a Responsible Pharmacist (RP) in the case of medicines or an Authorised Representative (AR) in the case of medical devices or IVDs to review and prepare applications on health products for submission to SAHPRA for registration in the case of medicines and licensing in the case of medical technology devices. There is no registered health product regulatory qualification currently; this is the first time a qualification for this regulatory occupation or role is being developed. The qualification also incorporates two-part qualifications: Health Products Vigilance Compliance Officer and Health Products Code Compliance Officer. The latter two occupations, which have their genesis in industry codes of practice, also do not have formal qualifications on which learners can be trained.

    As the number of health products grows significantly in view of scientific advancement (the plethora of health products being a case in point), the Health Products Regulatory Assistant qualification becomes critical to both fulfil the needs of the country for health products and standardise current but disparate training offered by companies dealing in health products.

    Another significant aspect is that the qualification will contribute to ensuring that there are trained individuals who will ensure that health products are safe to use. HPRAs will be qualified to apply health products regulatory authority's safety criteria for health products for registration and licencing purposes.

    The qualification has the potential of creating employment as it is needed in the industry and there is a potential uptake of the qualification by significant number of learners. Increased employment will translate into increased benefits for the economy.

    Typical learners will be those currently practising as Health Products Regulatory Assistants without having obtained a formal recognised qualification and school leavers wishing to enter the health products regulatory field. Learners working towards this qualification will find that the acquisition of competencies embedded in the modules will either enable them to obtain employment or add value to their job performance if they are already employed.

    In the development of this qualification, a range of stakeholders from the health products sector were consulted, including:
  • Training providers.
  • Regulator.
  • Employers/employer organisations.

    There are no similar Qualification(s) and Part-Qualifications registered on the NQF, and no Skills Programmes approved by the QCTO. 
    		•

    LEARNING ASSUMED TO BE IN PLACE AND RECOGNITION OF PRIOR LEARNING 
    Recognition of Prior Learning (RPL):
    RPL for Access to Training:
    Learners may use the RPL process to gain access to training opportunities for a qualification if they do not meet the formal, minimum entry requirements for admission. RPL assessment provides an alternative access route into a qualification.

    Such an RPL assessment may be developed, moderated and conducted by the accredited Skills Development Provider which offers that specific qualification. Such an assessment must ensure that the learner is able to display the equivalent level of competencies required for access, based on the NQF level descriptors.

    RPL for Access to the External Integrated Summative Assessment (EISA):
    For exemption from modules through RPL, learners who have gained the stipulated competencies of the modules of a qualification through any means of formal, informal or non-formal learning and/or work experience, may be awarded credits towards relevant modules, and gaps identified for training, which is then concluded.

    Entry Requirements:
    An NQF Level 4 qualification, with Mathematics and Science. 

    RECOGNISE PREVIOUS LEARNING? 
    Y 

    QUALIFICATION RULES 
    This qualification is made up of compulsory Knowledge, Practical Skill and Work Experience Modules:

    Knowledge Modules:
  • 242213-001-00-KM-01, Overview of Current Health Products Industry/Sector, Level 5, 5 Credits.
  • 242213-001-00-KM-02, Anatomy and Physiology, Level 5, 10 Credits.
  • 242213-001-00-KM-03, Health Products, Level 5, 8 Credits.
  • 242213-001-00-KM-04, Science for the Health Product Regulatory Assistant (HPRA), Level 5, 3 Credits.
  • 242202-001-00-KM-05, Codes of Practice for HPRAs, Level 5, 3 Credits.
  • 242213-001-00-KM-06, Registrations, Licensing, Applications, and Submissions, Level 5, 8 Credits.
  • 243302-001-00-KM-07, Vigilance and Post Marketing Surveillance, Level 5, 6 Credits.
  • 242213-001-00-KM-08, Professional Conduct, Level 4, 3 Credits.

    Total number of credits for Knowledge Modules: 46

    Practical Skill Modules:
  • 242213-001-00-PM-01, Submit Health Product Related Applications to the Regulatory Body, Level 5, 18 Credits.
  • 242213-001-00-PM-02, Conduct Compliance Activities on Health Products, Level 5, 6 Credits.
  • 242213-001-00-PM-03, Conduct Oneself Professionally and Ethically, Level 4, 3 Credits.
  • 242213-001-00-PM-04, Perform Vigilance and Post Marketing Surveillance, Level 5, 5 Credits.
  • 242213-001-00-PM-05, Communicate, Attend Meetings and Solve Problems, Level 4, 8 Credits.

    Total number of credits for Practical Skill Modules: 40

    Work Experience Modules:
  • 242213-001-00-WM-01, Processes to Submit Health Product Registration or Licensing Applications to a Regulatory Authority, Level 5, 20 Credits.
  • 242213-001-00-WM-02, Processes to Submit to a Regulatory Authority an Application for Amendment/Variation to a Registered or Licensed Health Product, 5 Level, 8 Credits.
  • 242213-001-00-WM-03, Processes to Submit the Health Product Establishment's Licensing Applications to a Regulatory Authority, Level 5, 8 Credits.
  • 242213-001-00-WM-04, Processes to Conduct Code Compliance Activities on Health Products, Level 5, 6 Credits.
  • 242213-001-00-WM-05, Processes to Perform Vigilance and Post Marketing Surveillance, Level 5, 6 Credits.

    Total number of credits for Work Experience Modules: 48 
    		•

    EXIT LEVEL OUTCOMES 
    1. Apply essential methods, procedures and techniques to submit applications pertaining to licences of healthcare establishments and registration of health products.
    2. Apply essential methods, procedures and techniques to submit applications pertaining to renewals, amendments/ variations and retentions.
    3. Interpret and apply appropriate procedures and criteria to conduct/perform code compliance activities on health products.
    4. Apply prescribed procedures to conduct / perform vigilance and post marketing surveillance to ensure the safe use of health products. 

    ASSOCIATED ASSESSMENT CRITERIA 
    Associated Assessment Criteria for Exit Level Outcome 1:
    ELO 1: Apply essential methods, procedures and techniques to submit applications pertaining to licences of healthcare establishments and registration of health products.
  • Obtain the regulatory body's online registration processes, guidelines and forms for all health products to ensure strict adherence in the application processes.
  • Obtain the regulatory body's licensing processes, guidelines and forms for all health establishments to ensure strict adherence to the licensing process.
  • Perform due diligence on the file/s provided by a licence holder.
  • Complete preparation of documentation for the various applications by giving due consideration to the regulatory body's validation (screening) and evaluation processes for health products.
  • Complete all forms and supporting physical and electronic documentation required by regulator for the application through adherence to regulatory body's requirements.
  • Utilise the regulatory body's electronic system or appropriate submission procedure/ mechanism to complete submission of dossiers for registration of a health product or licensing of a health establishment.

    Associated Assessment Criteria for Exit Level Outcome 2:
    ELO 2: Apply essential methods, procedures and techniques to submit applications pertaining to renewals, amendments/ variations and retentions.
  • Obtain the regulatory body's processes, guidelines and forms for renewals, amendments/variations and retention of all health products to ensure strict adherence to the application processes.
  • Perform due diligence on the file/s provided by a licence holder.
  • Complete all forms and supporting physical and electronic documentation required by regulator for the applications through adherence to regulatory body's requirements.
  • Utilise the regulatory body's electronic system or appropriate submission procedure/mechanism to complete submission of applications for renewals, amendments/ variations and retentions.

    Associated Assessment Criteria for Exit Level Outcome 3:
    ELO 3: Interpret and apply appropriate procedures and criteria to conduct/perform code compliance activities on health products.
  • Check the contents and artwork of promotional and educational materials for a health product for compliance to relevant codes and standard operating procedures (SoPs).
  • Check promotional activities for compliance with the relevant codes and SoPs and make recommendations for activities that do not comply.
  • Complete checks and corrections to promotional and educational materials and activities and appropriately file/save and update administrative records as per regulatory requirements.
  • Receive and lodge, escalate incoming and outgoing complaints pertaining to promotional and educational materials and activities, if required according to SoP.
  • Handle and escalate unethical practices regarding promotional and educational materials and activities if required according to SoP.

    Associated Assessment Criteria for Exit Level Outcome 4:
    ELO 4: Apply prescribed procedures to conduct / perform vigilance and post marketing surveillance to ensure the safe use of health products
  • Explain concepts, definitions and terminology associated with vigilance.
  • Complete and submit adverse reaction/event reporting form to the regulatory body in an assistive capacity through its appropriate submission procedure/mechanism.
  • Implement a health product recall assignment in an assistive capacity according to standard operating procedures.
  • Prepare a report on vigilance in an assistive capacity as per standard operating procedures.
  • Prepare recall letters and media releases in an assistive capacity and sent to the industry, standard operating procedures.

    Integrated Assessment
    Integrated Formative Assessment:
    Formative assessments are conducted throughout the training of learners. A range of formal, nonformal, and informal ongoing assessment activities is used to focus on teaching and learning outcomes to improve learner attainment.

    Formative assessments are conducted continuously by the facilitator to feed into further learning, to identify strengths and weakness, and to ensure the learner's ability to apply knowledge, skills and workplace experience gained.

    Formative Assessments are conducted by the accredited Skills Development Provider (SDP), and a variety of ongoing assessment methods may be used, for example, quizzes, assignments, tests, scenarios, role play, interviews. Continuous feedback must be provided.

    Integrated Summative Assessment:
    Integrated Assessment involves all the different types of assessment tasks required for a particular qualification, such as written assessment of theory and practical demonstration of competence. To achieve this, the Internal Assessment Criteria (IAC) for all modules as found in the QCTO curriculum document must be followed.

    An accredited SDP should implement a well-designed, formal, relevant, final internal Summative Assessment strategy for all modules to prepare learners for the EISA. These assessments evaluate learning achievements relating to the achievement of each module of the relevant components of the qualification.

    Internal Summative Assessments are developed, moderated, and conducted by the SDP at the end of each module or after integration of relevant modules, e.g., applied knowledge tests, workplace tasks, practical demonstrations, simulated tasks/demonstrations, projects, case studies, etc. 
    		•

    INTERNATIONAL COMPARABILITY 
    An international comparability study is undertaken to identify qualifications similar to this qualification from two other countries, namely, Canada and India.

    Country: Canada
    Institution: The Regulatory Affairs Professionals Society.
    Qualification title: Dual Certificate in Medical Devices and Pharmaceuticals.
    Duration: Online delivery for 12 Months.
    Entry requirements: N/A.

    The Regulatory Affairs Certificate: Medical Devices and Pharmaceuticals is achieved by completing six core and eight elective courses. After successfully completing all 14 courses, you will receive a certificate recognizing your achievement.

    Core Courses
    The following six courses are required:
  • Ethics
  • Global Regulatory Strategy for Medical Devices
  • Global Regulatory Strategy for Pharmaceuticals
  • Medical Devices: Definition and Lifecycle
  • Pharmaceuticals: Definition and Lifecycle
  • Role of the Regulatory Professional

    Learners are then expected to choose eight courses from our entire portfolio of programs

    Essentials:
  • Effective Regulatory Communication
  • EthicsEssential Tools for Regulatory Professionals
  • Project Management for Regulatory Professionals
  • Role of the Regulatory Professional

    Medical Devices:
  • Global Regulatory Strategy for Medical Devices
  • Medical Devices: Advertising and Promotion in the US
  • Medical Devices: Compliance & Audits
  • Medical Devices: Corrections, Removals and Directed Recalls
  • Medical Devices: Definition and Lifecycle
  • Medical Devices: Post market Surveillance
  • Medical Devices: Risk Management
  • Regulation of Combination Products
  • Regulation of IVDs in the US and Major Markets Outside the US

    Pharmaceuticals
  • Global Regulatory Strategy for Pharmaceuticals
  • Pharmaceuticals: Advertising and Promotional Labeling in the US
  • Pharmaceuticals: Compliance and Audits
  • Pharmaceuticals: Definition and Lifecycle
  • Pharmacovigilance
  • Regulation of Combination Products
  • Regulation of Biosimilars
  • Regulation of Dietary Supplements and NHPs
  • Regulation of Generic Drugs in the US
  • Regulation of US and EU Biologics
  • REMS and RMPs
  • Quality

    Similarities
    There are significant similarities between the about-mentioned certification course and the South African qualification. The courses below show the extent of overlap

    Essentials:
  • Effective Regulatory Communication
  • EthicsEssential Tools for Regulatory Professionals
  • Project Management for Regulatory Professionals
  • Role of the Regulatory Professional


    Medical Devices:
  • Medical Devices: Advertising and Promotion in the US
  • Medical Devices: Corrections, Removals and Directed Recalls
  • Medical Devices: Definition and Lifecycle
  • Medical Devices: Post market Surveillance
  • Medical Devices: Risk Management

    Pharmaceuticals:
  • Pharmaceuticals: Advertising and Promotional Labeling in the US
  • Pharmaceuticals: Definition and Lifecycle
  • Pharmacovigilance
  • Regulation of Combination Products
  • Regulation of Biosimilars
  • Regulation of Generic Drugs in the US
  • Risk Evaluation and Mitigation Strategies (REMS) and Risk Management Plans (RMPs)
  • Quality

    Another similarity is the duration - both are one-year programmes. The South African qualification is marginally longer. The South African qualification focuses on South African legislation and procedures etc. while the Canadian qualification focuses on US and Canadian legislation.

    Differences
    The following are the differences between the Canadian and the South African qualification.
    Medical Devices:
  • Global Regulatory Strategy for Medical Devices.
  • Regulation of Combination Products.
  • Regulation of IVDs in the US and Major Markets Outside the US.
    Pharmaceuticals:
  • Global Regulatory Strategy for Pharmaceuticals.
  • Regulation of IVDs in the US and Major Markets Outside the US.
  • Pharmaceuticals: Compliance and Audits.
  • Regulation of Dietary Supplements and Natural Health Products (NHPs).
  • Regulation of US and EU Biologics.
  • Risk Evaluation and Mitigation Strategies (REMS) and Risk Management Plans (RMPs).
  • Quality.

    Conclusion:
    Another difference is that the South African qualification has a significant module for Anatomy and Physiology, and soft skills modules like attending meetings and solving problems. In the Canadian qualification there is emphasis on the Regulation of Combination Products, any Dietary Supplements and Natural Health Products (NHPs).

    Country: India
    Institution: The Institute of Good Manufacturing Practices India (IGMPI).
    Qualification title: The Post graduate Diploma/Executive Diploma in Pharmaceutical Regulatory Affairs (PGDPRA/ EDPRA).
    Duration: 12 Months.
    Entry requirement: High-level qualification.

    Module 1: Introduction to Global Regulatory Authorities for pharma and healthcare industries.
    Module 2: Drug Development Process, Clinical Trials and related norms and regulations.
    Module 3: Regulatory Toxicology.
    Module 4: GMP and other good practices.
    Module 5: Documentation of drug trials and regulatory filings in US, Europe, UK, India, Japan, Canada, Australia, South Africa, etc.
    Module 6: Quality Assurance and Drug Regulations, ICH and WHO guidelines
    Module 7: Dossier preparation in CTD format, eCTD submissions.
    Module 8: Pharmaceutical Industry IPR, Patents, copyrights and Trademarks.
    Module 9: Pharma and Healthcare products- Marketing, Import and Export regulations.
    Module 10: Compliance guidelines, Govt. Audits (FDA, MHRA, PMDA, TGA, DCG, etc.) and Breach reports.
    Module 11: Indian GMP Regulations.
    Module 12: Drug Registration in African Countries.
    Module 13: Drug Registration in Gulf (GCC) Countries.
    Module 14: AYUSH Regulatory Affairs (Ayurveda, Unani, Siddha, Homeopathy, Yoga and Naturopathy).
    Module 15: Industry specific case studies.

    Similarities:
    Module 1: Introduction to Global Regulatory Authorities for pharma and healthcare industries.
    Module 2: Drug Development Process, Clinical Trials and related norms and regulations (partially).
    Module 4: GMP and other good practices.
    Module 6: Quality Assurance and Drug Regulations, ICH and WHO guidelines (partially).
    Module 7: Dossier preparation in CTD format, eCTD submissions.
    Module 8: Pharmaceutical Industry IPR, Patents, copyrights and Trademarks (partially).
    Module 9: Pharma and Healthcare products- Marketing.
    Module 10: Compliance guidelines
    Module 11: Indian GMP Regulations (yes, this qualification's focus is on South African GMP Regulations)
    Module 14: AYUSH Regulatory Affairs (Ayurveda, Unani, Siddha, Homeopathy, Yoga and Naturopathy) (yes, this qualification's focus is on alternative health products available in South Africa).

    Differences:
    Module 3: Regulatory Toxicology.
    Module 5: Documentation of drug trials and regulatory filings in US, Europe, UK, India, Japan, Canada, Australia, South Africa, etc.
    Module 9: Pharma and Healthcare products - Import and Export regulations.
    Module 12: Drug Registration in African Countries (The SA qualification focuses on this country only.)
    Module 13: Drug Registration in Gulf (GCC) Countries. (The SA qualification focuses on this country only.)
    Module 15: Industry specific case studies

    Further, the South African qualification is at NQF Level 5 while the Indian qualification is presumably at NQF Level 8. The Indian qualification is for a senior health products regulatory person while the South African qualification is for a Health Products Regulatory Assistant.

    Another major difference is that the Indian qualification does not cover medical devices. The (IGMPI) offers a Regulatory Affairs (Medical Devices) (12 months).

    Conclusion:
    Both the above-mentioned international qualifications compare well with the South Africa occupational qualification. 
    		•

    ARTICULATION OPTIONS 
    This qualification provides opportunities for horizontal and vertical articulation options.

    Horizontal Articulation:
  • Higher Occupational Certificate: Occupational Health and Safety Practitioner, NQF Level 05.
  • Higher Certificate in Healthcare Management, NQF Level 05.

    Vertical Articulation:
  • Occupational Certificate: Pharmacy Technician, NQF Level 06.

    Diagonal Articulation:
  • Advanced Certificate: Pharmacy Technical Support, NQF Level 06.
  • National Certificate: Vocational: Primary Health, NQF Level 04.
  • Diploma in Community Nursing Science, NQF Level 06. 
    		•

    MODERATION OPTIONS 
    N/A 

    CRITERIA FOR THE REGISTRATION OF ASSESSORS 
    N/A 

    NOTES 
    Additional Legal or Physical Entry Requirements:
    None.

    Criteria for the accreditation of providers
    The curriculum title and code are: Higher Occupational Certificate: Health Products Regulatory Assistant (HPRA): 242213-001-00-00.

    Encompassed Trade(s):
  • None.

    Assessment Quality Partner (AQP)
  • CHIETA

    Associated Qualification(s)/Part-Qualification(s):
  • Occupational Certificate: Health Products Code Compliance Officer, NQF Level 05.
  • Occupational Certificate: Health Products Vigilance Officer, NQF Level 05. 
    		•

    LEARNING PROGRAMMES RECORDED AGAINST THIS QUALIFICATION: 
     
    NONE 


    PROVIDERS CURRENTLY ACCREDITED TO OFFER THIS QUALIFICATION: 
    This information shows the current accreditations (i.e. those not past their accreditation end dates), and is the most complete record available to SAQA as of today. Some Primary or Delegated Quality Assurance Functionaries have a lag in their recording systems for provider accreditation, in turn leading to a lag in notifying SAQA of all the providers that they have accredited to offer qualifications and unit standards, as well as any extensions to accreditation end dates. The relevant Primary or Delegated Quality Assurance Functionary should be notified if a record appears to be missing from here.
     
    NONE 


    All qualifications and part qualifications registered on the National Qualifications Framework are public property. Thus the only payment that can be made for them is for service and reproduction. It is illegal to sell this material for profit. If the material is reproduced or quoted, the South African Qualifications Authority (SAQA) should be acknowledged as the source.