Medicines Control Council to fast-track sourcing of active pharmaceutical ingredients pre-qualified by the World Health Organisation, for the relevant medicines
During the meeting held with executives from a number of pharmaceutical companies on Friday 5 June 2015, the Minister of Health Dr Aaron Motsoaledi was informed that the pharmaceutical industry are experiencing problems supplying various medicines to both the private and public sectors.
The Department of Health is putting alternative measures in place to address this issue, with the assistance of the Medicines Control Council (MCC).
One of the reasons cited by the industry for the short supply of medicines is the non-availability of active pharmaceutical ingredients (APIs), which form the basis of any medicine.
The MCC has resolved to allow for the sourcing of APIs from alternative manufacturing sites that have been pre-qualified by the World Health Organisation (WHO). This will allow for expedited availability of some medicines, once an application for an API variation has been submitted, as MCC will use the WHO information to facilitate approval to ensure that any medicine that is in short supply is accessed.
The MCC will not need to evaluate the specific API or to inspect the API manufacturing site. MCC will continue to monitor the situation and to also liaise with other national medicines regulatory authorities in this regard. The MCC has a list of APIs that are pre-qualified by the World Health Organisation.
NB:
- The Medicines Control Council is a statutory health council responsible for the appropriate regulation of medicines, scheduled substances and medical devices, on the basis of efficacy, safety and quality.
- The work of the Medicines Control Council is guided by the Medicines and Related Substances Act (Act 101 of 1965), the Regulations issued in terms of that Act by the Minister of Health, and the guidelines published by the Council.
Enquiries:
Joey Gouws
Registrar: MCC 012 395 8003
E-mail: gouwsj@health.gov.za
