Medicines and Related Substances Bill tabled

Idea is to speed up registration of medicines….

doctorA new Bill has been tabled in Parliament, the Medicines and Related Substances Amendment Bill which proposes to replace the existing Medicines Control Council with a new body that will reflect better, it says, the many changes that have occurred in the industry.

It is proposed that the minister of health and therefore the department (DoH) will  have a far wider scope of regulatory control and adds the expression ‘complimentary medicines’ to its definitions.  The Bill has the intention, DoH says of  speeding up registration of medicines and will allow ‘mutual agreements’ with other worldwide drug registration institutions to enable the process of acceptance or rejection take place.

Committee experts

A new body of committees made up of experts and specialists will assist DoH with such process, the Bill says, but the decision making processes of the committee on the subject of registration of new drugs will still be kept  private as is the case in the principal Act since the proposals are silent on this issue.

The new body will be called the South African Health Products Regulatory Agency (SAHPRA) and according to the proposals will have a far wider regulatory mandate on activities across a broader spectrum of medical products. It will extend the base of control and its services to cover foodstuffs, cosmetics and the newly embraced complimentary medicines.

Business Day reported that experts from the US were assisting in the setting up of SAHPRA but gave no details of where these experts emanated from.
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