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Biological Medicines Evaluation and Research Unit (BMERU)

The Biological Medicines Evaluation and Research Unit (BMERU) is a sub-unit of Medicines Evaluation within the South African Health Product Regulatory Authority (SAHPRA). This sub-unit has been existing for a number of years and is primarily responsible for:

  • Evaluation of applications for registration of biological medicines. These include –
    • Review of dossiers for registration of biological medicines;
    • Review of applicant’s responses to recommendations from expert committees of the SAHPRA and
    • Handling all matters relating to biological medicines during review of applications for registration.
  • Evaluation of applications for amendments to registered biological medicines. These include –
    • Review of technical changes to registered biological medicines and “old” biological medicines;
    • Review of clinical aspects of package inserts and patient information leaflets for biological medicines.
    • Provision of technical support to other units (e.g. inspectorate) with respect to matters relating to biological medicines.
  • Other activities include communication with the pharmaceutical industry on policy matters affecting the registration and use of Biological Medicines, policy development and optimisation of the registration processes.
  • Establishment/Development of framework for regulation Blood and Blood products and Stem cells and cell based therapy following the pronouncement of Blood and blood components on the list of Essential medicines.
  • Establishment of relevant framework for regulation of Vaccines, Biosimilar and other
    biologicals

MEDICINES REGULATED BY THE BIOLOGICAL MEDICINES EVALUATION AND RESEARCH UNIT (BERU)

What are Biological Medicines – products that are produced from living organisms or contain components of living organisms.

 

Biological Medicines include a wide variety of products derived from human, animal, or microorganisms by using biotechnology.

 

Types of Biological Medicines include vaccines, blood, blood components, Bio therapeutics, biosimilar and recombinant proteins. Biologic products may contain proteins that control the action of other proteins and cellular processes, genes that control production of vital proteins, modified human hormones, or cells that produce substances that suppress or activate components of the immune system. Biologic drugs are sometimes referred to as biologic response modifiers because they change the manner of operation of natural biologic intracellular and cellular actions.

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BLOOD & BLOOD PRODUCTS

  • Blood, Blood Components, Blood Bank Devices, Blood Donor Screening Tests
  • Blood products e.g. for the treatment of hemophilia

HORMONES

  • Hormones for hormone deficiencies e.g. insulin for diabetes and growth hormone for growth hormone disorders

Monoclonal Antibodies

  • Monoclonal antibodies for the treatment of autoimmune diseases and cancers

Immunomodulators

  • Immunomodulators e.g. beta-interferon for multiple sclerosis

Vaccines

  • Vaccines for Use in Children and Adults, Tuberculin Testing
  • Vaccines to prevent a number of diseases.

Biosimilars

  • Is a biological product that is very similar to a reference biologic and for which there are no clinically meaningful differences in terms of safety, purity, and potency.

Enzymes

  • Enzymes e.g. to remove blood clots

Contact Biological Medicines Evaluation and Research Unit

  • Contact details
  • Manager’s Profile
  • Experts

Guidelines, Compliance & Regulatory Information

List of Guidelines

Scheduling for Prescribing by Authorised Prescribers November 2019

Scheduling of Medicine Guideline November 2019 v2

Proprietary Names Guideline November 2019 v6

Biological Medicines Evaluation And Research Unit (BMERU)

Biological Medicines Variations Guidance V3

Biological Medicines Pre-Registration Consultation Meeting Guidance

Pre-Registration Consultation Meeting Material Checklist

SAHPRA  – Biosimilar Medicines Guidance

Stability Testing Of Biological Medicines

  • National Control Laboratory (NCL) – Biological Medicines release laboratory
  • Hemovigillance

Pre – Registration Consultation Meetings

  • Guidelines
  • Types of meetings
  • Materials for Meeting
  • Procedures

Guidance, Rules, SOPPS, Establishment Registration, Enforcement, Compliance

  • Biological Medicines Press Announcement
  • Status of the Blood Regulation
  • Status of Regenerative Medicines Framework development
  • Number of Biosimilars registered

Immunisation and Annual Influenza Updates

  • Immunisation communication

Biological Medicines Advisory Committees

  • Public Advisory Committees
  • Calendar for the Meetings
  • Meeting Materials
  • How to become Advisory committee member
  • Guidance
  • Frequently Asked Questions

RECENTLY PUBLISHED BIOLOGICAL MEDICINES – RELATED GUIDANCES

  • News Letter
  • Guidance

News and Events

  • What’s New for Biological Medicines
  • Workshops, Meetings & Conferences (Biological Medicines)