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.
South Africa Moves 80% of General Freight by Road. That Is Not a Market Choice. It Is a System Failure.
Stabilising bulk export corridors was the right place to start - but it cannot be where the reform story ends. General freight will never move efficiently on rail alone. What manufacturing, automotive and agri-processing supply chains need is a seamless multimodal network where road, rail and port operate as one integrated system, not as separate silos. Fixing this is not a rail problem. It is a network problem, and it demands a network solution.
South Africa’s Freight Reform: The Plans Are Done. Now Comes the Hard Part.
Reform is real - Operation Vulindlela, third-party access, the NRMP. The direction is right. But progress is not the same as execution. The Rail Bill must now deliver the legal architecture that turns intent into action, and private capital will not move without the governance structures to back it. The hard yards are not behind us. They are in front of us.
South Africa’s Draft National Rail Master Plan: A Turning Point for Freight
Rail once drove 4% of South Africa's GDP. Today it contributes less than 0.1%. The Draft National Rail Master Plan sets out to reverse that decline — through open access, infrastructure reform, and a R1.9 trillion investment framework. The decisions made in the next 12 to 24 months will shape this country's freight system for decades. Read it. Comment on it. Engage.
Panellists discuss the progress made in rail reform and possible future actions
As South Africa’s freight system sits at a critical crossroads, with logistics costs estimated at between 11% and 12%, inefficiencies no longer just pose operational challenges, but create a direct constraint on economic growth.
Infrastructure Investing: Transforming A Price-takers Market
South Africa has bold ambitions to unlock over R1 trillion in infrastructure spend. If this is realised, this will translate into a series of transformative projects across energy, water, student housing, internet infrastructure and logistics hubs – the trick will be creating an enabling environment for investors to participate.
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.
South Africa Skincare Product Market Size & Share Analysis – Growth Trends and Forecast (2025–2030) | Mordor Intelligence
The South African skincare market is valued at USD 832.76 million in 2025 and is projected to reach USD 1.17 billion by 2030, growing at a CAGR of 7.06%. Facial care products dominate with a 79.23% revenue share, driven by growing consumer commitment to multi-step skincare routines, UV protection awareness, and a rising appetite for clinically-backed dermacosmetic formulations.
Women account for 88.78% of skincare spending, though the men's grooming segment is the fastest-growing end-user category at an 8.12% CAGR through 2030, supported by shifting attitudes toward male self-care and targeted influencer marketing. The mass segment holds a 66.28% share, while the luxury and premium segment is expanding at 7.97% CAGR, concentrated among affluent consumers in Gauteng and the Western Cape. Natural and organic formulations, while still a minority at 28.81% of the market, are growing at 7.89% CAGR, with local brands increasingly incorporating indigenous botanicals such as rooibos and marula oil. Online retail is the fastest-growing distribution channel at 8.04% CAGR, led by platforms like Takealot.com.
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.
South Africa Clinical Research Regulation Profile – NIAID ClinRegs
Maintained by the US National Institute of Allergy and Infectious Diseases (NIAID), this profile provides a comprehensive overview of the regulatory and ethical framework governing clinical trials in South Africa. The South African Health Products Regulatory Authority (SAHPRA) serves as the primary regulatory body, responsible for reviewing and approving all clinical trial applications, overseeing Good Manufacturing Practice compliance, and authorising the importation of unregistered medicines for trial purposes.
All clinical trials must receive dual approval from both SAHPRA and a registered Ethics Committee (EC) before commencing, with parallel review permitted. ECs are governed by the National Health Research Ethics Council (NHREC) and must be formally registered to conduct ethical reviews. The profile covers the full clinical trial lifecycle, including submission processes and content requirements, safety and progress reporting obligations, informed consent requirements for vulnerable populations, investigational product management, and specimen import and export rules.
South Africa Moves 80% of General Freight by Road. That Is Not a Market Choice. It Is a System Failure.
Stabilising bulk export corridors was the right place to start - but it cannot be where the reform story ends. General freight will never move efficiently on rail alone. What manufacturing, automotive and agri-processing supply chains need is a seamless multimodal network where road, rail and port operate as one integrated system, not as separate silos. Fixing this is not a rail problem. It is a network problem, and it demands a network solution.
South Africa’s Freight Reform: The Plans Are Done. Now Comes the Hard Part.
Reform is real - Operation Vulindlela, third-party access, the NRMP. The direction is right. But progress is not the same as execution. The Rail Bill must now deliver the legal architecture that turns intent into action, and private capital will not move without the governance structures to back it. The hard yards are not behind us. They are in front of us.
South Africa’s Draft National Rail Master Plan: A Turning Point for Freight
Rail once drove 4% of South Africa's GDP. Today it contributes less than 0.1%. The Draft National Rail Master Plan sets out to reverse that decline — through open access, infrastructure reform, and a R1.9 trillion investment framework. The decisions made in the next 12 to 24 months will shape this country's freight system for decades. Read it. Comment on it. Engage.
Panellists discuss the progress made in rail reform and possible future actions
As South Africa’s freight system sits at a critical crossroads, with logistics costs estimated at between 11% and 12%, inefficiencies no longer just pose operational challenges, but create a direct constraint on economic growth.
More than a sponsorship - this partnership with SA Rugby is built on shared values, trust, and a commitment to credible performance. An invitation to #UpYourStandards.
SA Rugby announced on Thursday that Biogen has joined its family of partners after signing a three-year sponsorship agreement which sees the premium wellness brand landing the vitamins and sports nutrition partnership to the Springboks, Springbok Women, as well as the national sevens and U20 teams.
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