The South African Health Products Regulatory Authority (SAHPRA) encourages members of the public to always report any suspected side effects they may experience from taking medicines, vaccines and/or using medical devices, to help make medicines safer for everyone. While humanity benefits greatly from medicines in the treatment of illness and management of certain conditions, medicines may at times cause side effects. However, the risk of side effects and severe harm can be drastically reduced by taking medicines correctly and following the advice of a healthcare practitioner.
SAHPRA, together with over 90 other medicines and health products regulators as well as healthcare organisations globally, is participating in the annual #MedSafetyWeek awareness initiative, which takes place between 4 and 10 November 2024, under the theme “the importance of using medicines in the right way to prevent side effects, and to report side effects when they do occur”.
The awareness initiative is spearheaded by the Uppsala Monitoring Centre under the auspices of the World Health Organisation (WHO) Programme for International Drug Monitoring, a programme whose member organisations work nationally and collaborate internationally to monitor and identify adverse effects of medicines and vaccines, to reduce risks to patients, and to establish worldwide pharmacovigilance standards and systems.
During this #MedSafetyWeek and beyond, SAHPRA is calling upon patients, caregivers and healthcare professionals to utilise its reporting tools to report all suspected side effects and adverse reactions.
SAHPRA Chief Executive Officer, Dr Boitumelo Semete-Makokotlela, indicates that handling and storing as well as taking medicines as directed by a healthcare professional is key in reducing the incidence of adverse reactions. “Research shows that about half of all side effects are preventable. Patient safety is our top priority and during #MedSafetyWeek, we wish to remind patients to take their medicines as instructed and healthcare professionals to review therapies as well as each patient’s unique health conditions before prescribing or dispensing medicines,” says Dr Semete-Makokotlela.
SAHPRA calls upon the South African public and healthcare professionals to use either the MedSafety App or the eReporting portal both accessible on the SAHPRA website to report suspected side effects from health products. All reports are assessed and examined by SAHPRA to determine the correct steps to protect medicine users in South Africa from harm. The purpose is to gain better knowledge about known side effects and to discover new ones. This can result in warnings and changes to how a medicine is used. SAHPRA’s MedSafety App and eReporting portal can be used for reporting suspected adverse drug reactions from medicines, vaccines, herbal products, biological medicines and any quality issues relating to health products.
The South African Health Products Regulatory Authority (SAHPRA) and the Australian Therapeutic Goods Administration (TGA) have signed a Memorandum of Understanding (MoU), which will strengthen collaboration between the two health product regulators.
The MoU builds on the existing relationship between the health products regulators to improve capabilities in the assessment of medical products and therapeutic goods and their monitoring for continued efficacy, safety and quality once they are registered.
Areas of cooperation
SAHPRA and TGA will engage in data sharing aimed at improving the regulatory functions executed by both regulators. This will particularly focus on the assessment and approval of medical products and therapeutic goods, their monitoring for continued efficacy, and the surveillance for safety and adverse reaction (event) concerns.
According to SAHPRA’s Chief Executive Officer, Dr Boitumelo Semete-Makokotlela, the agreement with the TGA expands the geographical reach for both regulators’ pharmacovigilance programmes and augments their internal expertise.
“This partnership enables us to rely on each other’s strengths and regulatory outputs in the evaluation of health products both before they are registered and once they are approved for public use. This would improve therapeutic outcomes for the populations we exist for and increase the robustness of our post-registration surveillance for efficacy, safety and quality,” says Dr Semete-Makokotlela.
Deputy Secretary at the Australian Government Department of Health and Aged Care and head of the TGA, Professor Anthony Lawler, said: “TGA is very pleased to have strengthened our collaborative relationship with SAHPRA with the signing of this international agreement. We look forward to working alongside our regulatory counterparts in South Africa to share important regulatory information to ensure the continued safety, quality and efficacy of therapeutic products approved for market.”
In a press release, the South African Health Products Regulatory Authority (SAHPRA) has hit back over what it terms “unfounded fallacies and misrepresentation” that has been “churned out by some media organisations without verification” over its draft B-BBEE Policy.
SAHPRA states that this policy “is proposed in order to comply with requirements of the Broad-Based Black Economic Empowerment Act, 53 of 2003, in particular Section 10(1)(a), which demands of all state entities to enact policy that can encourage inclusive economic participation.”
It states that the draft B-BBEE policy does not set “racial requirements” for the registration of medicines, as the first falsehood suggests, stating that it is not reflected in any of the documents.
The second falsehood is that “SAHPRA will use the B-BBEE to assess medicine registration applications and thus affect access to medicines”, which it says is a deliberate misrepresentation. The product registration processes “would continue to solely rely on the safety, quality, efficacy, and performance of the health products.”
The third falsehood is that the draft policy is aligned with NHI, seeking to exclude certain persons from state procurement. SAHPRA says that the policy is a move develop sector codes and/or criteria to comply with the B-BBEE Act, as has been done in other sectors of the economy.
SAHPRA states that the fourth and final falsehood is that the policy will deny participation by pharmaceutical SMEs as they may be unable to get B-BBEE certificates. The agency contends that compliance affidavits will be an acceptable alternative, and that in any case, the B-BBEE level of a business does not affect the medicines registration process – which will remain the case even after policy implementation.
The South African Medical Association has for years raised concerns about the criminalisation of medical errors, stressing that current legal practices may undermine patient safety and deter doctors from performing high-risk procedures.
Individual healthcare workers or teams of healthcare workers, like all other people, sometimes make unintentional errors. Though public recognition of the problem may be lacking, there is substantial scientific literature recording and describing the issue. In its landmark “To err is human” report published in 1999, the United States Institutes of Medicine wrote that “the problem is not bad people in health care – it is that good people are working in bad systems that need to be made safer”.
Medical errors can take many forms – from diagnostic and surgical, to medication and device and equipment. Pinning down a definition is hard although two formulations in academic literature are: “the failure of a planned action to be completed as intended or the use of a wrong plan to achieve an aim” and “unintentional deviation from safe practice”. Some argue against the use of the term “errors”, given that it stigmatises those who make “errors”.
A variety of approaches have been used to reduce medical errors. One of the most striking is the use of aeroplane-style checklists before and during surgery – with one such checklist having been backed by the World Health Organization. A review of such checklists published in the British Medical Journal in 2012 concluded that “surgical checklists represent a relatively simple and promising strategy for addressing surgical patient safety worldwide”.
Error v negligence
While the terms medical errors and medical negligence are often used interchangeably, they are in fact quite distinct, explains Professor Ames Dhai, SAMA’s vice chairperson and former director of the Steve Biko Centre for Bioethics at Wits University, in an interview with Spotlight.
“Medicine is exceedingly complex and errors do unfortunately occur from time to time (in most instances no harm comes from them). In most instances, the error cannot be attributed to the ‘fault’ of a person and is just a consequence of the procedure or other systemic factors.” The element of “fault”, Dhai says, is what distinguishes errors from medical negligence. Medical negligence occurs, she says, when the standard of care fails to meet the expected standard of the reasonable doctor in that discipline under the prevailing circumstances, leading to the patient suffering harm.
“If the ‘fault’ is deemed to be intentional, one is no longer negligent, and [therefore] potentially guilty of murder (the distinction being negligence vs intent),” Dhai explains.
“To be clear, doctors who are grossly negligent or reckless need to be held accountable. However, nearly all doctors don’t fall into this category. They are ethical, caring, and only want the best for their patients,” she says.
According to SAMA, due to a lack of proper, transparent structures to investigate, explain, account, and resolve instances of medical errors, families understandably turn to the criminal justice system for answers and accountability. This means some cases end up in court.
One high-profile case is that of paediatric surgeon Professor Peter Beale, who faces multiple charges, including three counts of murder and two of fraud, linked to the deaths of three children between 2012 and 2019. The state claims the deaths were caused by wrongful and negligent actions and unnecessary procedures by Beale.
But SAMA argues that the criminal justice system, designed for addressing criminal acts, is not the most suitable mechanism to navigate the complexities of medical practice. They stress that their concerns about charging, prosecuting, and convicting doctors in no way seek to minimise the impact of such devastating events on the families and loved ones involved.
“Instead, we are worried that criminalisation of bona fide medical errors and adverse events is an unsuitable response that would do little to prevent future tragedies and may in fact lead to other unwanted consequences that would be detrimental to both the profession and patients,” explains SAMA chairperson Dr Mvuyisi Mzukwa. He argues that criminalising errors would potentially ensure that they will be concealed and unreported, adding that “by hindering disclosure and reporting, one stifles opportunities to learn from errors and improve the system”.
But not everyone agrees. Dr Siraaj Khan, a lecturer at the Steve Biko Centre for Bioethics, describes the relevant law as straight-forward and says it is not in need of reform. “I think we need to differentiate being charged with medical negligence in a criminal court and being held liable or found guilty at the end of the day. And you’ll see that there are very few instances where a medical practitioner is actually found guilty,” he says. “So in my opinion, the law as it stands doesn’t require any intervention.”
Khan points out that if a medical doctor makes an error, it doesn’t automatically mean that they are negligent. The error has to be one that a reasonable doctor in the position of that particular medical doctor would not have made. Only if the standard falls short of the reasonable expert in that position will the conduct be criminalised, and that needs to be proven beyond a reasonable doubt in a criminal court. “So it’s a higher standard than that used in a civil court,” says Khan. “In a civil court, if there’s an action for medical negligence, it just needs to be proven on a balance of probabilities. Whereas if you charge a doctor with culpable homicide, for example, the standard of negligence needs to be proven beyond a reasonable doubt in a criminal court.”
But Dhai is critical of the status quo. She argues that the law, as it stands and as it is applied, may hamper patient safety and the achievement of a safety culture (where systems thinking, rather than individual blame, is applied to learn from incidents to create better systems and provide safer care). “The criminal justice system often ignores systemic factors to instead target the individual who happened to hold the scalpel when the incident occurred,” she says.
“The environment of fear and the threat of litigation and criminal proceedings may also disincentivise doctors from practicing in high-risk specialties or operating on complex and difficult cases, thereby impeding access to much-needed care,” Dhai adds. Khan acknowledges the argument that criminalising medical errors encourages defensive medicine, but, “on the other hand”, he says, “the counter-argument is that if we do criminalise this, it sets the standard and it would require doctors to act with more prudence when performing these operations”.
Gross negligence
SAMA’s position is that the threshold for criminal proceedings should be elevated from negligence to gross negligence and recklessness. As pointed out by Larisse Prinsen, a senior law lecturer at the University of the Free State, in an article published by The Conversation, gross negligence is the standard in countries such as New Zealand, Australia, and England. SAMA also says that investigators and the National Prosecuting Authority (NPA) should be specially trained to fully appreciate the complexities involved in medical errors and adverse events. The NPA is responsible for criminal prosecutions in South Africa.
Photo by Tingey Injury Law Firm on Unsplash
In addition to increasing the threshold for prosecution from negligence to gross negligence or recklessness, Dhai argues that there is much more that needs to be done. This includes better application of the law, including better complaint management, alternative dispute resolution, and support for affected patients and health practitioners.
Changes to the relevant laws might well be on the way.
The South African Law Reform Commission (SALRC) has confirmed to Spotlight that they “received a request from a coalition of various healthcare-related bodies asking that the SALRC conduct an investigation to review the law of culpable homicide and the application thereof in a healthcare setting”. According to the SALRC, the request was approved by the Minister of Justice and Correctional Services on 27 June 2023 and the research is underway as “Project 152 Criminal Liability of Healthcare Professionals”.
Though much of SAMA’s current spotlight is on criminalisation of medical errors, South Africa does also have a much wider challenge of medico-legal claims against provincial health departments. Most of these claims are for alleged medical negligence relating to birth-related complications, particularly cerebral palsy. Though amounts paid out are a small fraction of total claims, they nevertheless amount to hundreds of millions per year and are a severe strain on provincial health budgets. A bill aimed at addressing state liability in such cases was introduced in the last parliament, but has not been passed. The SALRC has for several years also been looking at the issue of medico-legal claims and published a discussion paper on the matter in November 2021, though more than two years later, their final report on the matter has not yet been published.
What about the HPCSA?
The Health Professions Council of South Africa (HPCSA) regulates health professions in the country. This involves, among others, managing the licensing of doctors.
As explained in an article by the Medical Protection Society’s Dr Yash Naidoo, less serious complaints made to the HPCSA are handled through a process of mediation. If complaints are more serious, or if mediation fails, a formal complaints process kicks in. In some cases, this can turn into a formal professional conduct inquiry.
“When a matter proceeds to a formal inquiry, that is when costs – money and time – start to escalate,” writes Naidoo.
“Think of the inquiry as you would a typical courtroom matter on television. The complainant is represented by the HPCSA’s pro forma complainant, and the practitioner is the respondent who may have their own legal representation. Each party can call witnesses and the inquiry itself can take a day or more – depending on the number of witnesses and the complexity of the matter.”
As Naidoo explains, penalties can range from a caution or reprimand to large fines or removal from the register (which amounts to the person no longer being allowed to work as a health professional).
Speaking to Spotlight, HPCSA’s Acting Head of Division Corporate Affairs, Priscilla Sekhonyana, says that the HPCSA has a dedicated line for lodging complaints and investigating authority and committees for adjudication of matters. “The HPCSA has committees of experts in place to adjudicate on matters and all rules of natural justice inclusive of fairness are observed.”
She says the council has engaged with various parties on the criminalisation of medical errors. The HPCSA respects the laws of the country, Sekhonyana says, but she also notes that practitioners are starting to be discouraged from engaging in what may be perceived as risky procedures. “The HPCSA has had engagements with the National Prosecuting Authority on the matter and unfortunately, the situation has remained the same. However, should there be activities aimed at legal reform, the HPCSA will participate in that process and make its views known at that juncture,” she says.
Spotlight made several attempts to get comment from the National Department of Health on the criminalisation of medical errors. The department had not provided a response by the time of publishing.
On 13 April 2024,the South African Health Products Regulatory Authority (SAHPRA) initiated a precautionary recall of two batches of Benylin Paediatric Syrup (batch numbers 329303 and 329304), in response to reported high levels of diethylene glycol in an alert by the Nigerian National Agency for Food and Drug Administration and Control (NAFDAC). The recall was implemented as a precaution to protect lives while SAHPRA investigated the reported high levels of diethylene glycol.
As the national regulatory authority for health products in South Africa, SAHPRA implements health product recalls as a crucial measure to address safety concerns or quality issues in the interest of public health.
As part of the investigation of the reported high levels of diethylene glycol, SAHPRA tested samples of the two affected batches of Benylin Paediatric syrup through an independent laboratory and a method developed by the World Health Organisation for testing products for the presence of diethylene glycol. The tests did not find traces of diethylene glycol in the recalled batches. This indicates that units of batches 329303 and 329304 that were stored at the required temperature would not contain unacceptable levels of diethylene glycol.
SAHPRA also wishes to indicate that there is no record of any adverse drug reactions relating to diethylene glycol for the two recalled batches in South Africa or anywhere else where they were exported to on the continent.
SAHPRA is mandated to regulate and apply due diligence to health products to ensure that products in circulation in South Africa and those exported from SAHPRA-licensed manufacturers are safe for public consumption. SAHPRA applies this due diligence throughout the product life cycle, from registration through to post-market monitoring.
“SAHPRA will continue to closely monitor medical products that have the potential of containing unacceptable levels of diethylene glycol. And we will continue to address safety concerns or quality issues so that the health of the public is protected,” says SAHPRA CEO, Dr Boitumelo Semete-Makokotlela.
On 10 April 2024, the South African Health Products Regulatory Authority (SAHPRA) received a report from the Nigerian National Agency for Food and Drug Administration and Control (NAFDAC) regarding the detection of high levels of diethylene glycol in a batch of Benylin Paediatric Syrup. SAHPRA immediately contacted the South African manufacturer, Kenvue (formerly Johnson and Johnson) for a response. Following engagements with the manufacturer and in the best interest of the public, it was resolved that affected batches would immediately be recalled while an investigation is ongoing.
SAHPRA, in collaboration with Kenvue, have identified the affected batch numbers as 329304 and 329303. These affected batches have been distributed to the following countries: South Africa, Eswatini, Rwanda, Kenya, Tanzania and Nigeria.
Benylin Paediatric presents as a clear, bright red syrup having a raspberry odour and taste, packed in amber glass bottles containing 100 mL with a plastic measuring cup. It is indicated for the relief of cough and its congestive symptoms and for the treatment of hay fever and other allergic conditions affecting the upper respiratory tract.
SAHPRA wishes to inform the public not to panic as the matter is being handled with priority. Batch recalls are batch-specific and do not necessarily apply to other batches/similar products. The manufacturer is a SAHPRA-licenced manufacturer and complies with Good Manufacturing Practices. The public is reminded that the recall is limited to two batches and should not panic regarding the range of products bearing the same name.
SAHPRA is alerting healthcare professionals and the public to discontinue the use of the two batches mentioned, remove them from their inventory and return them to their normal distribution channel(s) with immediate effect.
Classification of the recalls
The recall is classified as a Class 1, Type A recall, which is associated with a serious product quality concern that may have severe consequences. This is a country-wide recall. The product is being recalled from hospitals, retail outlets, healthcare professionals, authorised prescribers and individual customers or patients.
What the public should know
Diethylene glycol is toxic to humans when consumed and can prove fatal. Toxic effects can include abdominal pain, vomiting, diarrhoea, inability to pass urine, headaches, altered mental state, and acute kidney injury which may lead to death.
Members of the public who have consumed these two batches who experience any adverse reaction or witness it in children should consult their healthcare professional and report this using the Med Safety App or send an email to: adr@sahpra.org.za.
The recall is limited to batch numbers 329304 and 329303 of Benylin Paediatric Syrup.
“As a national regulatory authority, the recalling of medical products is a crucial measure to address safety concerns or quality issues so that we protect the health of the public. SAHPRA is recalling these two batches from the market due to reported high levels of diethylene glycol, with the potential to cause serious adverse events,” indicates SAHPRA CEO, Dr Boitumelo Semete-Makokotlela.
The MOU between SAHPRA and Rwanda FDA will allow the regulators to develop a cooperative partnership towards ensuring access to safe, quality, and effective health products in the respective countries.
Areas of cooperation
SAHPRA and Rwanda FDA will cooperate in joint products reviews and inspections to enable efficient access to health products. The World Health Organization (WHO) has set up an initiative for establishing a mRNA technology transfer hub, together with six spokes, in Africa as a strategy to increase mRNA vaccine production capacity in under-served regions and thus promote regional health security. Rwanda is one of the spokes and South Africa being the hub. Thus, building on this model, SAHPRA and Rwanda FDA will collaborate in the area of mRNA vaccines regulatory oversight.
“The forging of partnerships with fellow African National Regulatory Authorities, namely the Rwanda Food and Drug Authority allows SAHPRA to further our drive in enhancing and building capacity on the continent,” says SAHPRA CEO, Dr Boitumelo Semete-Makokotlela.
“The signing of this MoU underscores the profound potential of collaboration among African NRAs, affirming that the solutions to our shared challenges lie within our continent. Rwanda FDA staunchly believes in the power of collaboration and strategic partnerships. This MoU symbolises the culmination of dedicated efforts and signifies our unwavering commitment to facilitating mutual exchange and enhancing regulatory oversight. Through collaborative efforts with SAHPRA, we aim to strengthen our regulatory capacity and promote public health. As we embark on this journey together, let us harness the collective strength of our agencies to advance the pharmaceutical sector in Rwanda and beyond,” shares Rwanda FDA Director-General, Professor Emile Bienvenu.
The South African Health Products Regulatory Authority (SAHPRA) is aware of the product Lubri-A (Sterile Lubricating Jelly) manufactured by Electro-Spyres, classified as Class B medical device and currently being distributed across the country.
SAHPRA has been informed of multiple complaints received from health institutions, both public and private across the country. The complaints are as a result of a number of patients who became ill due to developing a fungal infection, caused by exposure to the fungal species, Wickerhamomyces anomalus (previously Candida pelliculosa) associated with use of Lubri-A (Sterile Lubricating Jelly).
Lubri-A is available in two presentations, the 2.5 g sachets and 50 g tubes.
Considering the wide usage of the product for lubricating purposes in medical and surgical procedures, the Regulator has taken a decision to urgently recall this product from the market as there are multiple contaminated batches, with the potential to cause serious and widespread nosocomial infections. SAHPRA is alerting healthcare professionals and the public to discontinue the use of the product, remove it from their inventory and return it through their normal distribution channel(s) with immediate effect.
As the source of the contamination of the product is still under investigation and not confirmed, all batches of Lubri-A are being recalled. Future manufacture and distribution of the product will be subject to review and authorisation by SAHPRA.
Classification of the recalls
The recall is being classified as a Class 1, Type A recall, which is associated with a serious product quality concern that may have severe consequences. This is a countrywide recall. The product is being recalled from hospitals, retail outlets, health care professionals, authorised prescribers and individual customers or patients.
What the public should know
Healthcare professionals that have used this product should contact their patients to determine any symptoms of infection after use of product.
The recall is limited to the product called LUBRI-A (2.5g and 50g sachets) and does not affect other lubricating gel products authorised for sale in South Africa.
The contact telephone numbers for Electro-Spyres are:
Landline: 011-608-3998 or 011-402-7208
WhatApp: +27-82-355-8862
“As a national regulatory authority, the recalling of medical products is a crucial measure to address safety concerns or quality issues so that we protect the health of the public. SAHPRA is recalling this product from the market as there are multiple suspected contaminated batches with the potential to cause serious and widespread nosocomial infections, ” indicates SAHPRA CEO, Dr Boitumelo Semete-Makokotlela.
The South African Health Products Regulatory Authority (SAHPRA) is aware of the falsified Ozempic products currently being sold on the market and online.
SAHPRA has been informed of advertisements regarding unauthorised Ozempic/semaglutide-containing products that are being disseminated through radio stations and social media platforms.
The Regulator is warning the public to be wary of products claiming to be Ozempic (semaglutide) which are not approved by SAHPRA.
Ozempic is a Schedule 4, prescription-only medicine, authorised by SAHPRA only for the treatment of type 2 diabetes mellitus in adults. SAHPRA has not authorised/registered Ozempic for weight-loss, therefore, use in that regard would be off-label. It must be noted that only a healthcare practitioner can make a Schedule 4 product available off-label as they would provide the requisite guidance and support to the patient/individual.
Novo Nordisk South Africa, who is the Holder of Certificate of Registration (HCR) has confirmed a national shortage of Ozempic stock; this resulted in limited access to treatment for diabetic patients. This may have created an opportunity for falsified/counterfeit products flooding the market claiming to be Ozempic and being used off-label for weight loss. Consumers should be wary of online offers for products claiming to be Ozempic or semaglutide.
Currently, there are no generic versions of this medicine being lawfully manufactured. Therefore, any product not manufactured by Novo Nordisk claiming to contain semaglutide is likely to be fake or counterfeit. The public is being exposed to many different types of unregistered/unauthorised products that are either substandard or falsified thereby putting their health at risk. See examples of registered vs counterfeit products.
Registered products safe to use Ozempic solution for injection is a registered product by SAHPRA belonging to the HCR, Novo Nordisk South Africa.
There are only two (2) registered presentations of the pre-filled pen for Ozempic available in South Africa namely, Ozempic 0,25 mg and 0,5 mg/dose pen and Ozempic 1 mg/dose pen.
What the public should know
Using unregistered semaglutide products claiming to have the effects of Ozempic bought from unverified/illegally trading suppliers could be detrimental to your health as these have not been evaluated by SAHPRA for safety, quality, and efficacy.
These falsified/fake Ozempic products may contain certain active ingredients found in the registered Ozempic products; however, the formulations or manufacturing processes may be different. These formulations have not been evaluated by SAHPRA.
SAHPRA urges the public to first consult their medical professionals for their health treatment and prescriptions, and only purchase or use SAHPRA registered/authorised products sold at registered pharmacies.
Any medicines that are bought outside of the legal supply chain:
May not contain any active ingredient.
May contain dangerous levels of the active ingredient.
May contain another active ingredient such as insulin instead of semaglutide.
May contain harmful inactive ingredients.
May be nonsterile and contaminated with microbes, therefore not suitable for injection.
“Protecting the health of South Africans is top of mind for the regulator. The scourge of unregistered, substandard, and falsified medicines on the market is a serious health risk for the public. SAHPRA is listening to the public concerns, and we have an ongoing investigation into these falsified Ozempic and unregistered semaglutide-containing products”, indicates SAHPRA CEO, Dr Boitumelo Semete-Makokotlela.
Public are urged to report any suspected products that are falsely claiming to work like Ozempic. You can report through these whistle blower platforms, SAHPRA’s 24-hour hotline (0800 204 307) or via our web reporting facility: .
The South African Health Products Regulatory Authority (SAHPRA) has been designated as a Regional Centre of Regulatory Excellence (RCORE) for Vaccines Regulatory Oversight for a period of four (4) years in the following functions:
Overarching Regulatory Systems
Marketing Authorisation and Registration
Vigilance
Market Surveillance and Control
Licensing of Premises
Regulatory Inspections
Laboratory Access and Testing
Clinical Trials
Lot Release
The rationale behind the African Union Development Agency, New Partnership for Africa’s Development (AUDA-NEPAD) designating RCOREs is to support continent-wide regulatory systems strengthening through leveraging capacity in better resourced regulators. The reality of medicine regulatory capacity limitation on the continent continues to hinder access to essential medicines as well as limit progress in regulatory harmonisation efforts. The intention is to address this regulatory gap and ensure the acceleration and strengthening of regional medicines regulatory harmonisation initiatives. RCOREs are required to support regulatory workforce strengthening through training in regulatory functions and enhance skills through hands-on training and exchange programmes amongst National Medicines Regulatory Authorities.
About RCOREs
The Regional Centres of Regulatory Excellence (RCOREs) is an initiative of the AUDA-NEPAD. As part of its mandate to strengthen regulatory capacity development in Africa, AUDA-NEPAD through its AMRH programme has designated 11 RCOREs in eight different regulatory functions which include:
Pharmacovigilance
Training in core regulatory functions
Quality assurance and quality control of medicines
Medicine registration and evaluation, quality assurance/quality control and clinical trials oversight
Licensing of the manufacture, import, export, distribution and inspection and surveillance of manufacturers, importers, wholesalers and dispensers of medicine
Clinical trials oversight
Registration and evaluation and clinical trials oversight
