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Regulations affecting Clinical Trials – South African Context

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The effect of the Regulations which directly affect Clinical Trials are potentially cumbersome for the Pharmaceutical Companies involved.

The General Medicines Regulations under the Act and the Regulations relating to Medical Devices and In Vitro Diagnostic Medical Devices, apply to medications and medical devices and IVDs respectively.

Regulations relating to the Clinical Research industry are of special interest to Pharmaceutical companies and medical device manufacturing companies which have or want to apply for the relevant registration to conduct clinical trials. The subsequent application for registration of their product, and the necessary licence to conduct their business in South Africa also fall under these regulations.

Regulation 16 under the Act (Regulations relating to Medical Devices and In Vitro Diagnostic Medical Devices) provides detailed information on requirements and is applicable when conducting related clinical trials.

Regulation 34 provides information regarding the application process, the relevant forms to use and which documents must accompany an application for authorisation to conduct a clinical trial. Included is the important requirement for informed consent which is a fundamental Human Right in terms of s12(2)(c) of the South African Constitution Act (108 of 1996 as amended).

Recalling medication or medical devices and/or IVDs

Recalls of registered medications and medical devices are not uncommon.

Recall is defined in the MCC/SAHPRA guideline as “the removal of specific batch/batches or lot/lots or serial number/s of a medical device or IVD from the market for reasons relating to deficiencies in the same quality, safety or performance”.

As a result of faulty devices being reported, more than 80 000 Epipen injectors across multiple countries, were recalled in 2017 because they “might fail to work in an emergency”. The contents of the devices, used for treatment of anaphylaxis to insect bites, stings or other severe allergies were normal but the needles were unable to inject the amount of fluid necessary, rendering the device defective.

The pharmaceutical’s acknowledgement of accountability and decisive action to voluntarily recall the product as a precautionary measure to safeguard patients was welcomed.

Responsibilities and Authority to recall or withdraw medicines, medical devices and IVDs

Within the newly proposed regulatory authority, there will be separate committees dealing with medicines and medical devices, and Diagnostics (which will include IVDs and Radiation Control). This provides stable platforms through which the regulation and compliance aspects of both separate divisions will be addressed.

Section 29 and s30 of the Medicines and Related Substances Act (101 of 1965), as amended, give authority to investigate any offences and apply penalties.

Once the Regulatory Authority identifies any reason for the registration of a medicine, medical device or IVD to be revoked, it will remove the certification in terms of s16.

In terms of s16(4), the responsibility to keep the registration and licencing of products updated remains that of the holder of the certificate and/or licence.

The MCC/SAHPRA guideline outlines the format and data requirements for reporting adverse events and post-marketing vigilance and monitoring requirements for Medical Devices and IVDs. The document outlines the circumstances in which the regulatory authority will take the necessary action to either recall a medication or medical device or withdraw it from the market completely.

Recalling medication from the market is often deemed to damage the reputation of a pharmaceutical company, but there is much to be said for the opposite. If it comes to light, for example, that medication had to be recalled but the pharmaceutical company consciously decided not to do so, the threat to public health and safety is tremendous and the reputational damage will be proportionally higher than it would be where the recall was confirmed and completed with the necessary urgency by the company who own the product.


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