Pharmaceutical companies have an increasing burden to address and comply with regulatory requirements which often span multiple geographies, markets, businesses, development activities and functions.
The challenge particularly falls on the compliance aspect of the processes in clinical research, as pharmaceutical companies persist in innovation and exploration during developmental stages of their products.
Recent developments within the industry, especially in the medical devices field, is indicative, that the “think outside the box” principle has been replaced with a “there is no box” belief.
With this level of innovation, exploration and accelerated invention, regulatory compliance has been considered the black sheep. Some within the research industry believe greater progress could already have been achieved had they not been expected to navigate the administrative red tape they are often confronted with.
Compliance officers within pharmaceutical companies will confirm that compliance failures can be costly. Costs relate not only to the monetary penalty in the form of fines but also remediation costs and, more importantly, the reputational damage the company may suffer.
There has been much debate on whether the requirements for compliance have a positive or negative effect on the production of often much needed medications.
The need for risk identification, using analysis and finding innovative processes to mitigate such risks, has become pertinent to the success of pharmaceutical and medical device companies across the globe.
The fact that different countries have different regulatory bodies, further adds to the challenges companies face when starting up clinical trials and ultimately entering into the research arena. It is often 10 years before a product is ready for market release.
South African Regulatory Body v other International Regulators
In South Africa the national regulatory body was previously known as the Medicine Control Council (MCC). This Council was replaced by the South African Health Products Regulatory Authority (SAHPRA) in terms of the Medicines and Related Substances Act (s2 of the Amendment Act (14 of 2015)), which was established as an organ of state within the public administration but outside the public service (s2(1)).
At the top of the list for SAHPRA is streamlining processes and increasing the level of service delivery previously managed by the MCC.
In 2016-2017 the registration of generic medications in South Africa had a timeline of 24 months. This is in stark contrast to the Swiss model which approved a total of 40 new active substances (NAs) in 2016 with a median approval time of 481 days.
Of the NAs approved in 2016 by Swissmedic (the Swiss surveillance authority for medicines and medical devices), 5% were approved by Swissmedic first or within one month of their first approval at the FDA (Food and Drug Administration), EMA (European Medicines Agency), PMDA (Japan), Health Canada or TGA (Australia).
It was estimated in 2017 that it took anything between two and seven years to register new medicines and clinical trials through the MCC in South Africa.
The poor state of the South African Regulator is clear. Those moving in the inner circle and dealing with the inner workings of the Regulator know that the sizeable backlog and continued influx of applications left the MCC unable to ensure compliance with required legislation and getting the relevant registrations through in a reasonable time.
The aim of SAHPRA appears to include a more user-friendly approach of which sharing information and cooperating with other regulatory agencies, such as the FDA and EMA, are most notable.
In terms of s2A SAHPRA will aim to “provide for the monitoring, evaluation, regulation, investigation, inspection, registration and control of medicines, Scheduled Substances, clinical trials and medical devices, IVDs and related matters in the public interest.”
The possibility of improved service delivery that will lead to increased registration of new and generic medication as well as medical devices and IVDs is greatly improved by having the Regulatory Authority function as a juristic person in a public entity capacity. There is further potential to create an environment where more clinical trials will be applied for and registered in South Africa. The prospects of many start-up companies hoping to join the clinical research and development market also increase substantially when viewed with this in mind.
Hopefully with these changes the South African Life Sciences market will be given the opportunity to expand on the established and continually growing industry which has seen the formation of several CRO (contract research organisations) and Data Management Companies in recent years.