A step towards Global Regulatory Harmonisation?
Regulatory Authorities are facing an increasing workload as a result of the growing number of generic applications on one hand, and the demand for accessible, lower-cost quality medicines on the other.
In an attempt to address this issue, Regulatory Authorities have tried to set the grounds for collaboration, towards a faster mechanism for the approval of generic products. As a result, the International Generic Drug Regulators Pilot (IGDRP) was launched in 2012, with the participation of the Regulatory bodies of EU (EMA), USA, Canada, Australia, Singapore, Switzerland, Brazil, China, Chinese Taipei, Republic of Korea, Japan and Mexico. Since its first launch, the Regulatory bodies of New Zealand, Russia and South Africa have also joined the IGDRP.
An Attractive Healthcare Market with Significant Regulatory Hurdles
With a population of 51 million, and a gross domestic product (GDP) that nearly tripled between 2000 and 2012, the Republic of South Africa (ZA) is the largest economy on the African continent and a member of the ‘BRICS’ group of emerging world markets. Whilst it cannot be denied that political and social problems still remain, South Africa has made great strides forward during the last quarter of a century. In December 2013, the eyes of the world were fixed on the country, as nations came together to mourn the passing of former president Nelson Mandela, who played a crucial role in the dismantling of apartheid and the re-emergence of South Africa from international isolation. This year will mark the 20 year anniversary of the country’s historic first ‘non-racial’ elections.
The past five years have arguably seen economic and political changes on an unprecedented and global scale. These changes have provided a new set of opportunities and challenges for the Healthcare industry.
There has been a dramatic level of growth in emergent national economies, notably the countries of Brazil, Russia, India, China and South Africa (BRICS). The magnitude of this shift in fortunes was recently highlighted in a United Nations Development Program report, within which was projected that the combined GDP of the BRICS nations would surpass the US and Western Europe by 2020. Such changes demonstrate a marked increase in the proportion of the middle classes, a greater level of personal spending and higher education as well as a concerted focus on healthcare. Such developments offer lucrative opportunities for companies to expand their market access to these markets and open up new revenue streams.