Registration Harmonization: An African Perspective

The rest of the world's romance with harmonization of registration procedures might just not be enough for the African continent, according to Johann Schlebusch, South Africa's Registrar of Medicines.

At the conference of the Southern African Pharmaceutical Regulatory Affairs Association in Pretoria this month, Prof Schlebusch pointed out that many people regard Africa as the lost and dark continent, riddled with poverty, ill-educated people, bribery, corruption, inadequate infrastructure - and a dumping site for substandard medicines and counterfeits.

"We know world trade in counterfeit medicines amounts to 6% of total world trade and is worth L12 billion ($19.1 billion)," he said, adding: "we know poorer countries are targets for much of those drugs. So while the world is making impressive efforts to harmonize medicine registration requirements, it is all of little significance to many countries in our continent, which find themselves at the mercy of an indigenous and local pharmaceutical industry that in some cases has taken over the role of the multinational 'big bad boy' image of some years ago, when dumping and other dubious practices were prevalent."