The South African Health Products Regulatory Authority, with the South African Pharmacy Council, recently announced what was described as a crackdown on a compounding pharmacy. They allege “critical regulatory non-compliance” in relation to the compounding of unregistered medicines. In his latest Inside The Box column, Dr Andy Gray provides some background to the issues at stake, while recognising that some key elements remain contested.
Fake and substandard medicines, along with bogus healthcare practitioners, pose a growing threat to patient safety in South Africa.
From unregulated weight loss injections to unsafe pain tablets, substandard and falsified medical products pose a threat to the health of people. Elna Schütz reports on how regulators are fighting the problem in South Africa.
We can generally trust that the medicines we buy at pharmacies contain what they are supposed to and that they were manufactured according to good quality standards. In his latest column, Dr Andy Gray zooms in on the regulatory scaffolding that enables this trust.
The sale of illegal medicines is a significant threat to public safety. In his latest Inside The Box column, Dr Andy Gray asks whether the South African Health Products Regulatory Authority has the necessary tools at hand to provide protection in this area.
In South Africa, as in many places, pharmaceutical companies are not free to change medicine prices as they wish. In his latest Inside The Box column, Dr Andy Gray unpacks how medicines prices are regulated in the country and considers how this regulatory framework might change.
There has been much confusion and misunderstandings about how cannabis and associated products are regulated in South Africa, with government’s own missteps adding to the uncertainty. In his last Inside The Box column for the year, Dr Andy Gray clearly sets out the current legal and regulatory situation and where we’re heading.
In several countries, the public is given an opportunity to share their views with regulators before new medicines are registered or to engage with those choosing essential medicines. In South Africa, however, opportunities for such public participation remains limited. In his latest Inside The Box column, Dr Andy Gray takes a look at how public participation is handled elsewhere and how it could be improved here.
Rather than trying to do everything from scratch, medicines regulators from different countries are increasingly sharing the load between them by ‘relying’ on each other’s work. In his latest Inside The Box column, Dr Andy Gray explains how such ‘reliance mechanisms’ can help regulators make decisions more quickly and efficiently, and digs into the details of how South Africa can make the most of these mechanisms.
For over 20 years, the law has required that the Minister of Health issues regulations to govern the advertising of medicines in South Africa, but as yet no such regulations are in place. In his latest Inside The Box column, Dr Andy Gray considers what this means for the marketing of medicines in the country.
It is easy to claim one is “following the scientific evidence”, but what does it mean to actually do so? In his latest Inside The Box column, Dr Andy Gray considers how evidence-based health policy and guidelines can and should be made.
Clinical trial participants appear to be well protected in South Africa, particularly as the country’s guidelines recognise the risks of research with international collaborators. The sudden end of US-funded clinical trials, however, is exposing some limitations of ethics codes and guidelines, argues Dr Andy Gray.
