| Summary: | A Research Report submitted to the Faculty of Health Sciences, University of Witwatersrand,
Johannesburg, in fulfilment of the requirements for the degree of Master of Science in Medicine
Pharmacotherapy
June 2016 === In the pharmaceutical sector, the health of the public is protected by medicines regulatory
authorities who enforce regulatory practices to be executed by pharmaceutical companies. In
South Africa, the Medicines Control Council (MCC) describes these practice requirements via
guidelines, which are based on the Medicines and Related Substances Control Act 101 of 1965.
The Regulatory Affairs Department is often the first point of contact between the regulatory
authority and the company. Regulatory affairs pharmacists therefore require broader skill sets
than scientific and technical skills. Global expansion of regulatory affairs has resulted in
significant skills shortage, for which a lack of education in regulatory affairs is partially
responsible. Lack of communication between academia and industry further contributes to this
skills shortage. In South Africa, the Pharmacy School curricula are approved by the South
African Pharmacy Council (SAPC) in keeping with The Pharmacy Act 53 of 1974. Regulatory
practices however, are determined by the Medicines and Related Substances Control Act. The
aim of this study was to assess if there are inconsistencies in regulatory affairs between the
pharmacy curriculum and job descriptions of regulatory affairs pharmacists, and to determine if
graduating pharmacists entering industrial pharmacy are equipped for their role in regulatory
affairs. The objectives were to examine regulatory education and regulatory practices in industry
to assess deficiencies in the required competencies of a regulatory affairs pharmacist. The
appropriate sections in Pharmacy curricula from all eight Pharmacy Schools in South Africa
were examined to assess the level to which regulatory affairs is taught, and the job descriptions
of regulatory affairs pharmacists were examined to assess the functional competencies required.
Survey studies were conducted in the Pharmacy Schools and Pharmaceutical Industry to
understand the gaps between what is taught and what is required in industry practice. The results
showed that B.Pharm undergraduates were insufficiently prepared for their role in regulatory
affairs, once they entered the Pharmaceutical Industry sector. Regulatory Affairs education is
covered partially at undergraduate level but in some detail at a post-graduate level, in some
Pharmacy Schools. Improvements are required to the current B.Pharm curricula, taking into
account the Medicines Act 101 of 1965 and with MCC Guidelines, to accommodate regulatory
affairs education. Collaboration between academia and industry has been proposed and
employed in other countries and have been shown to be successful, hence this is also
recommended for South Africa with most participants expressing a willingness to do so.. === MB2016
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