Legislation

Celebrating two decades of regulatory excellence

CTFA LOGOGlobal manufacturing industries are governed by regulations, the enforcement of which is overseen by associations, councils and governmental agencies. In South Africa, our cosmetics and pharmaceutical manufacturing industries are no different, with the majority of both markets operating within the scope of international guidelines.

CAMs regulations and guidelines a disappointment

The Department_of_Health_published_regulations_for_Complementary_and_Alternative_Medicines

The Department of Health published regulations for Complementary and Alternative Medicines (CAMs) on 15 November, along with guidelines for these products’ registration published on 8 November.

Medicines under additional monitoring must be clearly marked

At the end of April the European Medicines Agency published the initial list of medicines subject to additional monitoring, showing ‘an important deliverable of the new European pharmacovigilance legislation’.

Pharmaceutical companies fall short of B-BBEE

Keith BEECEO of BEE advisory firm EconoBEE, Keith Levenstein says that the pharmaceutical industry still has a large number of businesses that are not compliant – particularly many small- to medium-sized businesses, which are losing business as a result.

Monitoring the issue of medication errors

A close collaboration between national patient safety authorities, national competent authorities, the European Medicines Agency, and the European Commission is necessary to tackle the issue of medication errors causing harm in Europe. This was the conclusion of the workshop on medication errors organised by the agency last month.

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