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At MC Pharma, we value open communication and are keen on assisting you through your pharmaceutical regulatory journey in Africa. Contact us to discuss your needs and discover how our expertise can serve you.

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FAQ's

Quick Answers to Your Queries

The South African Health Products Regulatory Authority (SAHPRA) is the regulatory authority of South Africa responsible for the regulation of health products intended for human and animal use; the licensing of manufacturers, wholesalers, and distributors of medicines and medical devices; radiation emitting devices and radioactive nuclides; and the conduct of clinical trials.
Pharmaceutical regulatory companies in South Africa are required to comply with the regulations formed by the South African Health Products Regulatory Authority (SAHPRA). The Authority requires that a pharmaceutical manufacturer or wholesaler be licensed to manufacture, which may include a licence to import and/or export medicines, or to act as a wholesaler of medicines. Guidelines are issued by the Authority, from time to time, which relate to various matters including Good Manufacturing Practices (GMP) or Good Distribution Practices (GDP). All pharmaceutical manufacturers and wholesalers are required to comply with such guidelines.
The pharmaceutical regulatory environment in South Africa is complex and influenced by the country’s socio-economic paradigm. Some of the challenges faced by pharmaceutical regulatory companies in South Africa include poor regulatory environment, disparate regulatory requirements, uneven playing field, and inadequate financial resources.
Regulations impact pharmaceutical regulatory companies in South Africa by requiring them to comply with the regulations formed by the South African Health Products Regulatory Authority (SAHPRA). The Authority requires that a pharmaceutical manufacturer or wholesaler be licensed to manufacture, which may include a licence to import and/or export medicines, or to act as a wholesaler of medicines. Guidelines are issued by the Authority, from time to time, which relate to various matters including Good Manufacturing Practices (GMP) or Good Distribution Practices (GDP). All pharmaceutical manufacturers and wholesalers are required to comply with such guidelines.
Pharmaceutical regulatory companies in South Africa offer services such as strategic regulatory consulting, regulatory affairs and regulatory intelligence, registration pathways and license management services, end-to-end operational support, complete life cycle approach to CTD / eCTD dossier compilation and publishing, dossier preparation, review and management, regulatory submissions, medical writing, and more.

Pharmaceutical regulatory companies in South Africa ensure drug safety by complying with the regulations formed by the South African Health Products Regulatory Authority (SAHPRA). The Authority requires that a pharmaceutical manufacturer or wholesaler be licensed to manufacture, which may include a licence to import and/or export medicines, or to act as a wholesaler of medicines. Guidelines are issued by the Authority, from time to time, which relate to various matters including Good Manufacturing Practices (GMP) or Good Distribution Practices (GDP). All pharmaceutical manufacturers and wholesalers are required to comply with such guidelines.
The trends and the market are changing constantly and an in depth and programmatic approach to analysing the data for each service and product requires an knowledgeable consultant to gather and compile.
International pharmaceutical regulatory companies operate in South Africa by complying with the regulations formed by the South African Health Products Regulatory Authority (SAHPRA). The Authority requires that a pharmaceutical manufacturer or wholesaler be licensed to manufacture, which may include a licence to import and/or export medicines, or to act as a wholesaler of medicines. Guidelines are issued by the Authority, from time to time, which relate to various matters including Good Manufacturing Practices (GMP) or Good Distribution Practices (GDP). All pharmaceutical manufacturers and wholesalers are required to comply with such guidelines.
The future of pharmaceutical regulatory companies in South Africa is expected to be influenced by the establishment of the African Medicines Agency (AMA) which will significantly contribute to the improvement of regulatory systems in the Africa region.
Pharmaceutical regulatory companies in South Africa collaborate with drug manufacturers by ensuring that they comply with the regulations formed by the South African Health Products Regulatory Authority (SAHPRA). The Authority requires that a pharmaceutical manufacturer or wholesaler be licensed to manufacture, which may include a licence to import and/or export medicines, or to act as a wholesaler of medicines. Guidelines are issued by the Authority, from time to time, which relate to various matters including Good Manufacturing Practices (GMP) or Good Distribution Practices (GDP).