Masterstudiengang "Drug Regulatory Affairs"

Master-Thesis

Regulatory Affairs in the Gulf Cooperation Council Region

Bilal Alyousef (Abschlußjahr: 2021)

Summary
Language: English
The Gulf Cooperation Council (GCC) is a political and economic union involving six Arab states in the Gulf with shared economic and social objectives. It was created on May 25, 1981, comprising Bahrain, Kuwait, Oman, Qatar, Saudi Arabia and United Arab Emirates (UAE) Therefore, these countries are often referred to as the GCC states.
Throughout the three decades, since the establishment of the GCC, the Gulf states have experienced major challenges in view of the rapid change in the regulatory environment around the world. However, because of their strategic importance, position in the world and rich oil resources, they present significant potential for the growth of the pharmaceutical market. This growth, together with the increase in the price of medicines, has encouraged the GCC authorities to build their individual regulatory systems to deal with the considerable challenges in the pharmaceutical market. However, they realised that the pace of development in their individual markets is currently becoming significant.
The six states decided to formulate standardised regulations through their joint efforts to control the access of medicines into the Gulf region. In 1998, the GCC Drug Registration System (GCC-DR) was established as a result of the GCC vision three decades ago. At the same time, the six GCC governments took steps to harmonise their regulatory procedures and a set of guidelines and policies were produced.
Although an awareness of the important role of drug safety monitoring (pharmacovigilance) in the Gulf states has dramatically improved in recent years, communication of medicines benefits and harms between the various stakeholders, such as regulatory authorities, pharmaceutical industry, healthcare professionals and consumers, lags far behind. However, there are differences in the evolution of PV systems by regulatory agencies in these countries, as only some of them meet the requirements for conducting PV activities. Only 45% of Arab countries are official members of the World Health Organization (WHO) It is important to note that the PV system is generally in its early stages in the GCC region
The GCC governments are striving to decrease their dependence on branded pharmaceutical products by increasing local drug manufacturing through joint ventures and licensing deals with multinational pharmaceutical companies. This collaboration between the government and the pharmaceutical industry can be further extended to reach the consumer of medicines by effectively communicating benefits and risks to them.
Pages: 58