GUIDELINES TO GOOD MANUFACTURING PRACTICE FOR MEDICINES
A concise overview of Good Manufacturing Practice (GMP) requirements for medicines, outlining key regulatory principles, quality standards, and compliance considerations for manufacturers.
SAHPRA’s New Guidelines for Labelling of Medicines Intended for Human Use
This guideline, issued by the South African Health Products Regulatory Authority (SAHPRA), provides recommendations to applicants submitting registration applications for human medicines (Categories A and D). It aims to ensure consistency and accuracy in medicine labelling in line with the Medicines and Related Substances Act, 1965.
At minimum, proposed labels must comply with Regulation 10 of the Act, specify sugar quantity per unit dose, include instructions for use on outer packaging, and indicate the medicine's category and classification. Applicants are also required to submit full-colour mock-ups of both outer and immediate packaging in electronic format, with different colours strongly recommended to distinguish between different strengths.
The label content, once approved, may not be changed without SAHPRA's explicit authorisation. This guideline is valid for five years from its effective date.
SAHPRA Communication to Stakeholders: Traceability Guideline – Implementation Roadmap
SAHPRA has issued a phased implementation roadmap for unique product identification across all health products in South Africa, transitioning from batch-level tracking to full unit-level serialisation. The process is structured in two phases: Phase 1 (2025–2029) focuses on batch-level identification using GTINs, expiry dates, and batch numbers, while Phase 2 (2027–2031) introduces unique serial numbers to achieve complete product serialisation across primary, secondary, and tertiary packaging.
Imported products face earlier compliance deadlines than domestically manufactured ones, with batch-level requirements taking effect from October 2027 for imports and October 2029 for local products. All barcodes must meet GS1 technical standards, and manufacturers are required to maintain unique identifier records for five years after product expiry. Excluded from these requirements are whole blood, homeopathic medicines, extemporaneous preparations, and food and related supplements.
Infrastructure Modernization for South Africa Development Policy Loan
World Bank Infrastructure Modernization Loan for South Africa
The World Bank has approved a US$1.5 billion Development Policy Loan (DPL) to support South Africa's critical infrastructure reforms. The financing targets the country's deepening economic crisis, where unemployment exceeds 31 percent and GDP growth has averaged below 1 percent over the past decade.
The operation focuses on three key pillars: improving energy security by attracting private investment into transmission and distribution; enhancing freight transport efficiency by establishing an independent economic regulator and unbundling state-owned Transnet; and supporting South Africa's transition to a low-carbon economy.
If successful, the reforms could boost short-term GDP growth by 1 percent and generate up to 250,000 jobs by 2027, rising to 500,000 by the early 2030s.
Infrastructure SA preparing 34 projects to come to the market before end-2026
Infrastructure South Africa (ISA) is currently preparing and packaging 34 projects with an estimated capital value of R259-billion, says ISA acting head Mameetse Masemola, with these projects "hopefully coming to market" over the next 12 to 18 months.
The State of Railway Infrastructure in South Africa
South Africa’s rail network reflects stark contrasts in asset condition and operational resilience across freight, commuter, and rapid transit systems.
GUIDELINES TO GOOD MANUFACTURING PRACTICE FOR MEDICINES
A concise overview of Good Manufacturing Practice (GMP) requirements for medicines, outlining key regulatory principles, quality standards, and compliance considerations for manufacturers.
SAHPRA’s New Guidelines for Labelling of Medicines Intended for Human Use
This guideline, issued by the South African Health Products Regulatory Authority (SAHPRA), provides recommendations to applicants submitting registration applications for human medicines (Categories A and D). It aims to ensure consistency and accuracy in medicine labelling in line with the Medicines and Related Substances Act, 1965.
At minimum, proposed labels must comply with Regulation 10 of the Act, specify sugar quantity per unit dose, include instructions for use on outer packaging, and indicate the medicine's category and classification. Applicants are also required to submit full-colour mock-ups of both outer and immediate packaging in electronic format, with different colours strongly recommended to distinguish between different strengths.
The label content, once approved, may not be changed without SAHPRA's explicit authorisation. This guideline is valid for five years from its effective date.
SAHPRA Communication to Stakeholders: Traceability Guideline – Implementation Roadmap
SAHPRA has issued a phased implementation roadmap for unique product identification across all health products in South Africa, transitioning from batch-level tracking to full unit-level serialisation. The process is structured in two phases: Phase 1 (2025–2029) focuses on batch-level identification using GTINs, expiry dates, and batch numbers, while Phase 2 (2027–2031) introduces unique serial numbers to achieve complete product serialisation across primary, secondary, and tertiary packaging.
Imported products face earlier compliance deadlines than domestically manufactured ones, with batch-level requirements taking effect from October 2027 for imports and October 2029 for local products. All barcodes must meet GS1 technical standards, and manufacturers are required to maintain unique identifier records for five years after product expiry. Excluded from these requirements are whole blood, homeopathic medicines, extemporaneous preparations, and food and related supplements.
Infrastructure Modernization for South Africa Development Policy Loan
World Bank Infrastructure Modernization Loan for South Africa
The World Bank has approved a US$1.5 billion Development Policy Loan (DPL) to support South Africa's critical infrastructure reforms. The financing targets the country's deepening economic crisis, where unemployment exceeds 31 percent and GDP growth has averaged below 1 percent over the past decade.
The operation focuses on three key pillars: improving energy security by attracting private investment into transmission and distribution; enhancing freight transport efficiency by establishing an independent economic regulator and unbundling state-owned Transnet; and supporting South Africa's transition to a low-carbon economy.
If successful, the reforms could boost short-term GDP growth by 1 percent and generate up to 250,000 jobs by 2027, rising to 500,000 by the early 2030s.
Infrastructure SA preparing 34 projects to come to the market before end-2026
Infrastructure South Africa (ISA) is currently preparing and packaging 34 projects with an estimated capital value of R259-billion, says ISA acting head Mameetse Masemola, with these projects "hopefully coming to market" over the next 12 to 18 months.
GUIDELINES TO GOOD MANUFACTURING PRACTICE FOR MEDICINES
A concise overview of Good Manufacturing Practice (GMP) requirements for medicines, outlining key regulatory principles, quality standards, and compliance considerations for manufacturers.
SAHPRA’s New Guidelines for Labelling of Medicines Intended for Human Use
This guideline, issued by the South African Health Products Regulatory Authority (SAHPRA), provides recommendations to applicants submitting registration applications for human medicines (Categories A and D). It aims to ensure consistency and accuracy in medicine labelling in line with the Medicines and Related Substances Act, 1965.
At minimum, proposed labels must comply with Regulation 10 of the Act, specify sugar quantity per unit dose, include instructions for use on outer packaging, and indicate the medicine's category and classification. Applicants are also required to submit full-colour mock-ups of both outer and immediate packaging in electronic format, with different colours strongly recommended to distinguish between different strengths.
The label content, once approved, may not be changed without SAHPRA's explicit authorisation. This guideline is valid for five years from its effective date.
SAHPRA Communication to Stakeholders: Traceability Guideline – Implementation Roadmap
SAHPRA has issued a phased implementation roadmap for unique product identification across all health products in South Africa, transitioning from batch-level tracking to full unit-level serialisation. The process is structured in two phases: Phase 1 (2025–2029) focuses on batch-level identification using GTINs, expiry dates, and batch numbers, while Phase 2 (2027–2031) introduces unique serial numbers to achieve complete product serialisation across primary, secondary, and tertiary packaging.
Imported products face earlier compliance deadlines than domestically manufactured ones, with batch-level requirements taking effect from October 2027 for imports and October 2029 for local products. All barcodes must meet GS1 technical standards, and manufacturers are required to maintain unique identifier records for five years after product expiry. Excluded from these requirements are whole blood, homeopathic medicines, extemporaneous preparations, and food and related supplements.
Infrastructure Modernization for South Africa Development Policy Loan
World Bank Infrastructure Modernization Loan for South Africa
The World Bank has approved a US$1.5 billion Development Policy Loan (DPL) to support South Africa's critical infrastructure reforms. The financing targets the country's deepening economic crisis, where unemployment exceeds 31 percent and GDP growth has averaged below 1 percent over the past decade.
The operation focuses on three key pillars: improving energy security by attracting private investment into transmission and distribution; enhancing freight transport efficiency by establishing an independent economic regulator and unbundling state-owned Transnet; and supporting South Africa's transition to a low-carbon economy.
If successful, the reforms could boost short-term GDP growth by 1 percent and generate up to 250,000 jobs by 2027, rising to 500,000 by the early 2030s.
Infrastructure SA preparing 34 projects to come to the market before end-2026
Infrastructure South Africa (ISA) is currently preparing and packaging 34 projects with an estimated capital value of R259-billion, says ISA acting head Mameetse Masemola, with these projects "hopefully coming to market" over the next 12 to 18 months.
Infrastructure Modernization for South Africa Development Policy Loan