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.
  • Evaluation of applications for amendments to registered biological medicines.
  • Vaccine Lot Releases
  • 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.
  • 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.
  • Lot Release
    • Manage applications for Vaccine lot testing and document review for lot/batch release.
    • Manage database of tested, reviewed and released vaccine lots.
  • 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 frameworks for regulation blood and blood products, stem cells and cell based therapy following the pronouncement of blood and blood components on the list of essential medicines.
  • Establishment of relevant frameworks 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.

Vaccine Lot Release

The South African Health Products Regulatory Authority (SAHPRA) is responsible for all vaccine lot release activities within South Africa and have contracted with the South African National Control Laboratory for Biological Products (SANCLBP) to support it in carrying out this regulatory oversight function.

 

The SANCLBP is a South African National Accreditation System (SANAS) ISO/IEC 17025:2017 accredited pharmaceutical testing laboratory which performs quality control tests on vaccines for human use in South Africa. The SANCLBP is also a World Health Organisation (WHO) contracted laboratory for testing prequalified vaccines and a full member of the WHO National Control Laboratory Network for Biologicals (WHO – NNB) and is committed to the current best international practice for the lot release testing of vaccines.

 

The SANCLBP was established in 1998 at the University of the Free State through a tender from the National Department of Health (NDoH). The mission of the SANCLBP is to ensure that all vaccines for human use meet the quality standard as registered by SAHPRA before it is released to the market.

 

  • Biological medicines such as vaccines are complex products. They differ from pharmaceuticals in that they are produced via a biological manufacturing process. The potential variability intrinsic to these manufacturing processes and, therefore the biological product, requires that they are subjected to extensive quality control testing.
  • Vaccines are used in healthy populations and thus, safe and effective vaccines are essential public health tools that are strictly regulated internationally. This ensures that the vaccines are manufactured according to the required prerequisites and specifications of registration before they can be placed on the market.
  • Vaccine lot release activities, as conducted by the SANCLBP, are part of the regulatory process of vaccines and involve the independent evaluation of each vaccine lot before it is released onto market. All vaccines registered by SAHPRA or authorised under Section 21 are subject to lot release by SAHPRA. Vaccine lots will be released for public use only if they conform to the required specifications.

 

Search for Lot Release here

More information on SANCLBP

 

  • It has modern facilities that include virology, cell culture, microbiology, biophysical chemistry, immunochemistry, and molecular biology.
  • This institution maintains the highest standards by complying with the ISO/IEC 17025:2017, WHO Guidelines, and SAHPRA GMP standards.
  • It strives to collaborate with other African countries by making its laboratories available for testing when required and providing training opportunities.
  • It also maintains international collaboration with other control laboratories in Europe, the UK, and the WHO.

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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

Application forms

List of application forms

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 Guidelines

  • Newsletters
  • Guidelines

News and Events

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