Where next? Geographic expansion: the regulatory perspective. Part 3: South Africa
SummaryPart three of a four part series
In a new blog series, Kimty Bui-Van of ProductLife Group considers how increasing regulatory harmony between regions is improving the prospects for companies looking to grow their global opportunity
South Africa under the spotlight
As the gateway to the African continent, South Africa is an important pharmaceutical market, though its regulatory regime remains in a state of flux.
In June 2017, the government introduced the Medicines and Related Substances Amendment Act and is establishing the new South African Health Products Regulatory Authority (SAHPRA) to oversee medical devices and medicinal products. SAHPRA will replace the Medicines Control Council, but its full scope will be implemented over two years.
These are the latest in a series of steps to shake up the regulatory environment. Such steps have also included a move away from the old Medicine Registration Form format to the Common Technical document (CTD), which has been mandatory since 2016. South Africa is also an observer of the International Council for Harmonisation’s (ICH’s) guidelines and to a large extent follows European Union guidelines for the submission of marketing applications.
Defining market characteristics
he South African regulatory environment is stringent. Regulators carefully assess every submission and expect companies to strictly adhere to CTD guidelines. And firms submitting marketing authorisation applications in South Africa must be locally based pharmaceutical companies.
Each company must also have a responsible person in the form of a pharmacist registered with the South African Pharmacy Council. The person must ensure adherence to laws related to medicine control and is accountable for all technical and regulatory issues involving a company’s products in South Africa. The responsible person has wide-reaching legal and regulatory responsibilities as well by being responsible for quality aspects related to releases of products onto the market and for ensuring that all standard operating procedures are in place, that the site master files get compiled, that dossiers are compliant, that pharmacovigilance requirements are being met, and that marketing material is compliant with regulations.
Despite its 11 official languages, South Africa currently requires labelling in only English and Afrikaans, but there has been discussion as to whether the patient information leaflet should be made available in other languages.South African–based pharmaceutical companies, subsidiaries, and consultants commonly handle submissions for other African countries, including Botswana, Ghana, Kenya, Mauritius, Namibia, Tanzania, and Uganda. Each country has its own regulatory nuances, requiring experts with relevant knowledge and good working relationships with in-country agents to ensure local compliance.
Even though old dossiers can remain in their existing Medicine Registration Form format, if a chemistry, manufacturing, and control variation is submitted, the company must convert the entire submission to CTD and submit a fully updated Module 3. Although this involves a lot of work, many old dossiers contain only scant information, so an update is necessary.
Perhaps the most significant challenge for companies, though, is the national agency’s regulatory backlog: the approval process currently takes around five years. One cause of this was a sudden influx of generic applications in response to price control measures. In addition, the government’s focus on certain diseases that affect a large proportion of the population—such as HIV and tuberculosis—resulted in an increase in associated product applications. More recently, it was decided to do away with fast-track evaluation, too, to ensure all products get evaluated equally.
In 2015, South Africa initiated an electronic CTD (eCTD) pilot involving 18 products, which provided good insights into the eCTD process for both companies and regulators and helped speed the review process for at least some of those 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. The verdict
As a pharmaceutical market, South Africa is the largest in sub-Saharan Africa—valued at €2.52 billion—and is expected to grow at a compound annual rate of 7.4% from 2014 to 2019, according to data from IMS Health (renamed IQVIA in 2017).
From a regulatory point of view, the market follows ICH guidelines similar to European Union requirements. The use of South Africa as a base for building regulatory submissions for other African countries is also highly appealing. All things considered, we can expect South Africa’s prominence in companies’ international growth plans to rise in the coming years.
In the next and final blog, Kimty Bui-Van surveys the current regulatory conditions and market growth prospects for life sciences in Canada.
Kimty Bui-Van is head of regulatory affairs and pharmaceutical services at ProductLife Group.