Tag Archive | registration of drugs

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.
Previous articles in this category

Posted in Facebook and Twitter, Health, LinkedIn, Trade & Industry0 Comments

This website is Archival

If you want your publications as they come from Parliament please contact ParlyReportSA directly. All information on this site is posted two weeks after client alert reports sent out.

Upcoming Articles

  1. Jeremy Cronin back on land expropriation issue
  2. Integrated Energy Plan reflects cleaned-up thinking
  3. Changes to Companies Act headed for Parliament
  4. State Bank a strong possibility with certain provisos
  5. No more Competition Commission yellow card warnings
  6. Business to meet transformation targets by law

Earlier Editorials

Earlier Stories

  • AARTO licence demerit system studied  …. In what has been a legislative marathon, the update of the Administrative Adjudication of Road Traffic Offences Act (AARTO) has now reached a stage […]

  • SARS role at border posts being clarified …. In adopting the Border Management Authority (BMA) Bill, Parliament’s Portfolio Committee on Home Affairs agreed with a wording that at all future one-stop border […]

  • Modernising SAPO a culture change ….. sent to clients 27 February…. Stage by stage, Mark Barnes, Group Chief Executive Officer of South African Post Office (SAPO), appears to be reforming cultures and […]

  • OECD money task force waiting for SA   ….sent to clients Feb 7…. Chairperson of the Standing Committee on Finance, Yunus Carrim, made it quite clear in terms of parliamentary rules that […]

  • President Zuma vs Parliament on FICA Bill …..editorial……The convoluted thinking that is taking place in South Africa to avoid the consequences of the law has once again become evident in […]