entire submission must be converted
to CTD and a fully updated Module 3
The South African regulatory
environment is stringent, and firms
submitting marketing authorization
applications in South Africa must be
locally based. Each company must
have a responsible person in the form
of a pharmacist registered with the
South African Pharmacy Council to ensure adherence to medicine controls
and be accountable for all technical
and regulatory issues.
South Africa–based pharmaceutical
companies and representatives
commonly handle submissions for
Botswana, Ghana, Kenya, Mauritius,
Namibia, Tanzania, and Uganda, and
satisfying each country’s regulatory
nuances requires experts with relevant
knowledge and good working
relationships with in-country agents.
The national agency’s regulatory
backlog is probably the biggest area
of concern for companies targeting
African markets. Although measures
are being taken to tackle the backlog,
the South African approval process
currently takes around five years.
In 2015, South Africa initiated an
electronic CTD (eCTD) pilot involving
18 products, which provided good
insights into the eCTD process and
helped speed the review process
for some products. Even though
eCTD applications are now accepted
for both new chemical entities and
generic applications, the time frame
for compulsory submission in eCTD
format has not yet been set.
As a pharmaceutical market, South
Africa is the largest in sub-Saharan
Africa—valued at € 2.52 billion ($3.13
billion)—and is expected to grow at a
compound annual rate of 7. 4 percent
up to 2019, according to IQVIA
(formerly IMS Health). South Africa’s
i “Baltic states’ pharma markets continue to emerge from crisis,” IHS Market, 17 December 2013.
ii 2016 Top Markets Report Pharmaceuticals Country Case Study, Canada, International Trade Administration.
iii Competitive Alternatives: KPMG’s Guide to International Business Locations Costs, 2016.