South Africa Joins European Pharmacopoeia as Observer

15-Jul-2013 - Last updated on 16-Jul-2013 at 10:36 GMT

South Africa’s decision to join the European Pharmacopeia as an observer comes as the country looks to obtain more expertise on quality standards.

The Medicines Control Council of South Africa -- which joins Morrocco, Tunisia, Guinea, Senegal and Algeria among its African counterparts, and 20 other observers, including the World Health Organization – will now be able to attend the pharmacopeia commission’s sessions.

The council, unlike a number of regulators in neighboring African countries, has made a push in recent years towards more transparency by seeking industry comment on new regulations and guidance, as well as keeping its website up to date.

Although observer states to the European Pharmacopeia are not required to institute the monographs or chapters, some, such as Canada and Australia, have done so in the past.

The eighth edition of the European Pharmacopeia includes more than 2220 monographs and 340 general chapters on the specifications for active substances and excipients used in medicines. The standards are official for all 37 member states and the EU.

Draft Resolution

In addition to the South Africa announcement, the EDQM (European Directorate for the Quality of Medicines & HealthCare), which supports the EU Pharmacopeia, announced Monday that it would craft a draft resolution aiming to harmonize the quality and safety standards around the production of pharmaceuticals in pharmacies.

Following a survey in 2008 by the Committee of Experts on Quality and Safety Standards for Pharmaceutical Practices and Pharmaceutical Care, the EDQM found “a wide gap” in quality assurance and standards for pharmacy-made medicinal products between EU countries, as well as a gap in quality assurance between preparation in pharmacies and medicines prepared by the pharmaceutical industry.

The Committee of Ministers also has adopted a resolution on quality and safety assurance requirements for medicinal products prepared in pharmacies as the US FDA looks to crack down on such compounding pharmacies, which produced drugs that led to numerous deaths in the US.