Drug regulatory authorities are constantly challenged to develop and improve their capacity to regulate pharmaceutical products. Therefore, it is critical to develop regulations based on two broad objectives, namely, to provide technical assistance in establishing and implementing effective strategies for monitoring quality and correcting deficiencies and to refine existing methods to ensure optimal regulatory services through an applied quality management programme. The regulations must be broad enough to address all the essential issues, but flexible enough to be applied to specific problems.

In the world of medicines regulations, the term ‘quality’ is associated with data on the pharmaceutical characteristics of the medicinal product and the processes for chemical and manufacturing control (CMC). Increasingly, however, the term ‘quality’ is also being used in discussions of the drug regulatory process itself. It is not enough to measure regulatory performance in terms of timelines and the speed of the review process alone. The quality of the process, from the construction of the dossier to the ultimate regulatory decision, must also be monitored and added to the equation (Cone and McAuslane 2006).

Past attempts to compare review processes of different regulatory authorities have been hampered by insufficient public information, together with the complexity of the processes themselves. Even though, for some authorities, a review performance is becoming more transparent, the lack of uniformity between countries puts considerable limitations on the interpretation of different review times (CMR R&D Briefing 11 1997). Pressures on regulatory authorities from the general public for rapid access to new medicines have led health authorities worldwide to seek new measures for improving their own review processes. However, regulatory authorities are faced with the responsibility of reducing review timelines as well as maintaining the quality of the review procedures. To achieve this aim, the regulatory authorities should have a legal basis for all its functions, sufficient human and financial resources and access to appropriate scientific expertise and to a quality control laboratory. However, different regulators have different definitions of ‘quality’, but they all agree that the term is defined in the light of the provider’s standards and patients’ expectations. The quality of the review process stems from the quality of care provided to the public, and the degree of quality is the extent to which the care provided is expected to achieve the most favourable balance of benefits and harms (Donabedian 2005; Brown et al. 1998).

In order to assess the quality of the review process conducted in the GCC authorities, a clear understanding of the current situation, an identification of the practices and standards, the level of expertise and technical support as well as the accessibility to procedures and information within the authorities are essential. Therefore, the regulatory functions involved in the review procedures were examined, and a comparative view of the quality measures were established to produce a valuable insight into aspects of the good review practices (GRPs) in the GCC authorities.

The six GCC regulatory authorities (Bahrain, Kuwait, Oman, Qatar, Saudi Arabia and United Arab Emirates (UAE)) provided detailed information on the quality measures employed within their agency, and these were validated in face-to-face meetings. The GCC countries have the unique advantage of having a similar economic background and culture, the same language and similar historical background and political characteristics. These advantages are the main factors that play a prominent role in the success of the GCC Central Drug Registration (GCC-DR) system. Therefore, the GCC regulatory authorities, being in their developing stage, were chosen for comparison and to achieve standardisation on the basis of these similarities, unlike the systems of the mature agencies such as the United States Food and Drug Administration (US FDA), the European Medicines Agency (EMA), Health Canada and Australia’s Therapeutic Goods Administration (TGA) which are advanced and complex and differ significantly from one country to another.

Six quality measures were considered critical in the evaluation of the regulatory review process in the Gulf states, namely, joint and shared review (JR/SR), peer review (external and internal), assessment templates, standard operating procedures (SOPs), good review practice (GRP) and a quality policy (QP). The GCC authorities completed all the questions, and where questions were not applicable, no response was provided. However, the answers received were sufficient to provide the required information for the study. Furthermore, the respondents had the opportunity to express their comments and viewpoints in more detail for each question.

The measures currently used by each GCC regulatory authority to achieve quality in the review process are shown in Table 4.2. The results indicated that a joint review is the only quality measure shared by all six GCC authorities. It is a practice that is performed by all the authorities for the GCC Central Drug Registration (GCC-DR) system, where a dossier is reviewed by each authority and the outcome is discussed in a conference meeting after which the decision is made by consensus. The other quality measures are practised in some authorities, whilst other authorities have plans to implement them in the future.

Finally, only Kuwait has a dedicated department or unit for the quality assurance of the assessment and registration process. Whilst Kuwait has a small unit consisting of two pharmacists, the unit does not yet officially exist in the current organisational structure of the authority, and its functions are not fully regulated or enforced. UAE stated that the quality assurance department does not exist for the assessment and registration process, but it does have an independent department reporting to the CEO of the Medical Practices and Licensing, to which the Registration and Drug Control Department reports. Nevertheless, their work has not yet been fully implemented.

The study also examined the existence of committees and their associated procedures involved in the review process. Committees are a necessary aspect of organisations of any significant size (i.e. more than 15 or 20 people), and they are a way to formally draw together people of relevant expertise from different parts of an organisation who otherwise would not have an appropriate way to share information and coordinate actions. They may have the advantage of sharing viewpoints and responsibilities. They can also be supported with experts to recommend actions in matters that require specialised knowledge or technical judgment. After assessing the committee’s procedures as an element to improve the quality of the registration of medicines in each authority, it was found that Kuwait and Qatar did not have scientific committees that are integrated into their assessment procedure, and therefore they were not included in this part of the assessment (Table 4.4).

However, Qatar does have a registration committee that makes the final approval decision, and Kuwait has recently begun adopting this approach as well. In three authorities (Saudi Arabia, Oman and Bahrain), the committees are responsible for assessing the applications and making the final approval decision. However, in UAE, separate scientific committees exist for each area, e.g. stability, quality control, GMP, bioequivalence studies, minor variations and internal peer reviews and external screening committee. All reports of the scientific committees are then discussed in the higher registration committee after the scientific committees have given their opinions, and the higher registration committee then makes the final approval decision.