Improving healthcare in developing countries remains a priority for the global health community. Access to healthcare, including
medicines, is on the agenda of policymakers, national regulatory authorities (NRAs), the pharmaceutical industry, and many
nongovernmental organizations. Globally, significant resources are being committed to support efforts to expand access to
medicines in accordance with the leadership responsibilities of national governments and international regulatory agencies.
These efforts are evident through a wide range of partnership initiatives such as the Pharmaceutical Inspection Convention
and Pharmaceutical Inspection Co-operation Scheme (PIC/S, see sidebar "About PIC/S").
PIC/S is designed to assist NRAs in strengthening their inspectorates and regulatory standards. PIC/S members achieve this
by harmonizing their processes for inspecting quality systems and their good manufacturing practice (GMP) guidelines; promoting
networks with regulatory authorities in different nations to develop mutual confidence; exchanging information and practical
experience with GMP and related topics; mutually training inspectors; and supporting GMP inspectors.
PIC/S leaders acknowledge that the role of a NRA is to guarantee the quality, safety, and efficacy of medicines made available
to the public and that GMPs are the mainstay of quality assurance in pharmaceutical production and control. GMP recommendations
and legislation alone do not determine the success of quality assurance. Quality, as a concept, and GMP-compliance by the
pharmaceutical industry are also dependent on effective implementation, appropriate enforcement, and a common interpretation
and understanding of GMP principles by the appropriate authority's GMP inspectorate team and by the regulated industry.
The Medicines Control Council (MCC) of South Africa joined PIC/S in July 2007, becoming the African continent's only PIC/S
member. The following section discusses the regulatory body's accession to the international group.
South Africa's quest for membership
South Africa's journey to attain PIC/S membership was not without its share of challenges. Buy-in from all stakeholders, including
political leaders, the government, and industry, was essential to allow for a joint strategic approach.
The first requisite to improving the availability of good quality medicines in South Africa was to obtain political support
and determination for the harmonization of pharmaceutical GMP requirements with international standards. In addition, industry
support for the strengthening of the national regulatory system with regard to GMP promotion had to be obtained. Fortunately,
both the government and industry supported MCC's goals, and the council began the application process in 1997.
With regulatory and industry support, MCC researched the country's 1965 Medicines and Related Substances Act 101 to determine
what types of amendments needed to be made. The Act provides for the registration of human and veterinary medicines and the
establishment of a medicines control council and appropriate committees with the mandate to register medicines based on quality,
safety, and efficacy. The council also has the authority to regulate the purchase and sale of medicines by pharmaceutical
manufacturers, wholesalers, and the retail sector and to appoint inspectors to enforce the Act.
The MCC team concluded that amendments needed to be made to the Act to require that pharmaceutical companies that manufacture
(total or partial), package, label, import, export, distribute, or test any type of medicine obtain a manufacturing license
from MCC and that wholesalers or distributors of medicines obtain a wholesaling license from MCC. These amendments were passed
in 2003 with the enactment of the Amendment Act.
In addition, the MCC's GMP Inspectorate developed a quality management system to address a suitable code of practice, conflicts
of interest, standard operating procedures for inspection activities, and appropriate inspectorate enforcement. This system
was established in line with the provisions of the Medicines Act.
MCC also had to ensure that pharmaceutical products available in South Africa meet national and international standards of
safety, efficacy, and quality, a harmonized approach to GMP, in line with PIC/S's prescribed requirements. The council worked
with the domestic industry to adapt and adopt the PIC/S GMP Guidelines to support their own national regulatory framework.
The council gained industry support for the new standards by holding a series of 13 MCC-industry workshops between January
2004 and January 2005.
The next hurdle facing MCC was to increase the capacity of its GMP Inspectorate by strengthening its administrative, structural,
and technical elements. MCC also appointed a quality manager to ensure compliance with the newly developed quality system.
The council then tackled industry compliance with the updated GMP requirements. MCC's goal was to advance industry's GMP standards
to an acceptable level by using and developing the variety of experiences and technical expertise available throughout the
country and by calling in external expertise where needed. An additional MCC-industry workshop was held in February 2006 to
discuss and clarify key aspects of the new guidelines. MCC officials found that an open-door policy to advise and guide (rather
than consult) was the best approach to take with industry. Two major drug-manufacturing compliance issues requiring changes
among industry were the clean-class concept and enforcement of GMP principles by contract acceptors.
Finally, in September 2006, a team of senior inspectors from five PIC/S member authorities assessed MCC and its progress.
The assessment team made several observations, to which MCC responded, and in July 2007, South Africa's MCC was granted membership
in PIC/S—a first for Africa.
Looking back, it is clear that MCC could not have achieved PIC/S membership without support from industry and other groups.
A collaborative effort was critical to meeting common goals. Today, MCC continues to strengthen its regulatory capacities
by tapping into the pool of PIC/S expertise. In addition, PIC/S membership has provided South Africa with the opportunity
to draw on the technical resources of developed countries and the opportunity to build technical capacity as well as a repository
of critical information to keep its medicines safe and effective.
Joey Gouws, PhD, is director of Inspectorate and Law Enforcement at the National Medicines Regulatory Authority for South Africa's Department
of Health, firstname.lastname@example.org