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Post-Marketing Reporting of Adverse Drug Reactions to Human Medicines in South Africa  

MedicinesBiologicalsHerbal Cosmetic Nutra | South Africa

Every applicant is required to report ADRs known to them involving their marketed medicines in accordance with the requirements of Act 101 of 1965 Regulation 40. The success of the Authority’s ADR reporting system depends on the quality, completeness, and accuracy of the information submitted. Reporting of ADRs and monitoring thereof, remain a viable means of identifying previously unrecognized, rare, or serious ADRs.

This guideline describes the following points;

  • Pharmacovigilance Obligations of The Holder Of A Certificate Of Registration/ Applicant
  • Adverse Drug Reaction Reports
  • Procedures for Reporting
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Access to Unregistered Medicines – South Africa  

Medicines | South Africa

SAHPRA is mandated to regulate the safety, efficacy, and quality of all medicines. Prior to registration
of a medicine, access is usually limited to clinical trials authorized by the Authority. SAHPRA may,
in certain circumstances, and in accordance with Section 21 of the Act, authorize the sale of an
unregistered medicine for such purposes and in such manner and during such period as the
Authority may determine.

This guideline describes the following points;

  • Possible Access Scenarios
  • Roles and Responsibilities
  • Application Process
  • Evaluation Process
  • Record Keeping
  • Reporting

 

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MD010: Regulatory Requirements, Technical Specifications, Licence Conditions and Authorisation for Use of Unregistered Rapidly Developed Invasive and Non-Invasive Ventilators for Covid-19  

Medical Devices | South Africa

A rapidly developed invasive or non-invasive ventilator classified as a Class C medical device in terms of the Medicines Act must comply with the latest version of the above referenced WHO specification (refer clause 6) and Appendix B of the MHRA specifications (refer clause 7), with adaptations in line with relevant South African legislation and standards, for purposes of emergency use during the Covid-19 pandemic in South Africa.

This guideline describes the following points;

  • Current Medical Device Licence and Regulatory Process
  • Hazardous Substances Act
  • Minimum Regulatory and Licensing Requirements for a manufacturer or distributor of a rapidly
    developed ventilator for emergency use during the Covid-19 pandemic
  • License Application Process and Timelines
  • Local manufacturers of invasive or non-invasive ventilators
  • Conditions of Licence and Authorisation for use of unregistered ventilators
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Lot Release Guideline for COVID – 19 Vaccines  

Biologicals | South Africa

The lot release of human vaccines by the South African National Control Laboratory for Biological
Products are performed within the framework of the Medicines and Related Substances Act, 1965 (Act
No. 101 of 1965) as amended and Act 14 of 2015, regulations 15(1) and 15(2).

This guideline should be read together with the latest National Control Laboratory (NCL) circular on
General Information Regarding Vaccines and Lot Release, which is available on request at
(NclFHS@ufs.ac.za)

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Pre- Registration Consultation Meeting  

Biologicals | South Africa

This guidance document is to describe the procedures involved in the scheduling and conduct of Pre-Registration Consultation (PRC) meetings between the Office of the CRO of the SAHPRA and the applicant/sponsor of biological medicines. The primary purpose of the meetings is to address issues relating to the development of a product in the planning phase of such products.

This guideline describes the following points;

  • Terms, Definitions, and Abbreviations
  • Types of PRC Meetings
  • Procedure for Request To Schedule Meetings
  • Pre-Registration Consultation Meeting Material
  • Cancellation of Meeting

 

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Roadmap and Transitional Process for the Regulation of Complementary Medicines  

Herbal Cosmetic Nutra | South Africa

This document establishes the roadmap and general overview of the regulatory pathway of complementary medicines including licensing in terms of section 22C(1)(b) and submission of applications
for their registration following the implementation of the General Regulations in 2017 and applies to
products for human (discipline-specific medicines and health supplements).

This guideline describes the following points;

  • Guidance for Regulatory Priorities associated with Complementary Medicines
  • Summary of legislative control of Complementary medicines
  • Summary of General Timelines
  • General advice to consumer

 

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Guideline for The API Master File (APIMF) Procedure  

Medicines | South Africa

An Active Pharmaceutical Ingredient Master File (APIMF) contains all the required information for the quality
evaluation of an API. The APIMF is comprised of two parts:

  • The open part: The applicant must have access to this information, and it must be sufficient for the
    applicant to ensure the suitability of the API used in the finished pharmaceutical product (FPP)
  • The closed part: The applicant does not have always access to this information, which is
    the confidential intellectual property of the API manufacturer, including a detailed description of the
    the manufacturing process (with individual steps ), manufacturing quality control procedures, process
    validation etc.

The objectives of the APIMF Procedure are as follows:

  • To ensure that the API manufacturer’s proprietary information is managed confidentially end-to-end
  • To allow one evaluation of an API from a specific manufacturing site to be used across multiple
    finished pharmaceutical product (FPP) evaluations, reducing quality evaluation timelines.
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Interim Variations Addendum for Human and Veterinary Medicines  

Medicines | South Africa

The South African Health Products Regulatory Authority (SAHPRA) has decided to harmonize certainly
SAHPRA human medicine policies and procedures with those of the European Medicines Agency
(EMA). These, in turn, are aligned to the framework of the International Council for Harmonisation of
Technical Requirements for Pharmaceuticals for Human Use (ICH), as well as the International
Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal
Products (VICH).

This article describes the following points;

  • Implementation
  • Definitions
  • Exceptions to the EU variation classification guidelines
  • Fees

 

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