The most significant regulatory initiative that the GCC member states have proactively implemented as part of their goal to standardise their regulatory systems is the Common Technical Document (CTD). The CTD format was adopted in all member states in January 2012 as part of the central registration procedure. This initiative reflected the assessment processes carried out by each individual authority and became the official review practice in all member states including Yemen. Pharmacovigilance (PV) and medicines communication has also been an important initiative by the GCC countries, but it has not yet been fully regulated to reach the European or US standards even though they base their PV initiatives on the European PV guidelines.

The current dynamics of bringing new medicines to market are being influenced by conflicts between the agendas of regulators and payers (CMR 2009). This dilemma has been further complicated by previous high-profile drug withdrawals, the increasing need to improve the drug development systems and to avoid exposing patients to unnecessary risks of possibly ineffective treatments (Eichler et al. 2008). Despite the existence of standards for drug regulation now for at least 50 years, there are still many problems with the safety and efficacy of medicines in both developing and developed countries. The regulators are under pressure from the pharmaceutical industry to approve medicines more quickly by minimising regulatory ‘bottlenecks’ and to carry out reviews and evaluations of data in the shortest possible time.

Medicines are not ordinary commodities as patients are not in a position to make appropriate decisions about when to use them. Due to the sophisticated scientific issues related to medicines, basic training in pharmacy may not be sufficient to make appropriate judgments about medicines quality, efficacy and safety (American Pharmaceutical Group (APG) 2010). Public health interests are the responsibility of all regulatory authorities. However, in practice this means balancing the interests of industry (commercial productivity) and patients’ needs (Hashan 2005). The same challenges caused the emergence of the GCC regulatory dilemma and its impact on patients’ access to medicines in the six Gulf states (Bahrain, Kuwait, Oman, Qatar, Saudi Arabia, and UAE).

The GCC regulatory authorities are under pressure to fulfil several responsibilities towards the public, industry, media, politicians, and towards each other. They need to satisfy the industry and public demands by making safe and effective medicines available in a timely manner, to coordinate their efforts to make sure that these medicines are approved quickly without negatively impacting the quality of the assessment process, to ensure that these medicines are not overpriced and to respond to media and policymakers with maximum transparency about why certain medicines are approved or rejected.

Historically, the Gulf states faced significant challenges in dealing with their established regulatory bodies that were struggling to accept the concept of shared efforts and give up their autonomies to the newly established GCC Central Drug Registration (GCC-DR) system. This system was initiated after the European Centralised Procedure had succeeded in overcoming numerous challenges and had earned the trust of both European (EU) member states and the pharmaceutical industry since its inception in 1995. The GCC-DR challenge in the beginning was to convince companies to consider submitting their dossiers to the Centralised Procedure. The submission process was voluntary, as the GCC-DR could not implement a compulsory system until a certain level of standardisation in the regulatory review systems has been reached. The six authorities have enforced the Centralised Procedure by only allowing GCC centrally registered products to enter the Gulf Cooperation Council (GCC)’s joint tender for drugs and healthcare products. However, pharmaceutical companies are still having mixed feelings about whether they can gain faster marketing authorisation and improved decision-making through the national regulatory systems or the regional centralised system. Currently, two approval routes, national and centralised, are permitted to exist side-by-side in the GCC region. But for the centralised system to dominate, member states should seek ways to increase their collaborative efforts to bring their systems closer towards a standardisation that would facilitate the regional registration process and maintain patients’ access to safe and effective medicines within a reasonable time frame.

The purpose of this study has been to evaluate the currently adopted Common Technical Document (CTD) as the standardised format for the GCC regulatory review process in order to determine its impact on the speed and quality of the review process in each. Detailed information was provided by the GCC regulatory authorities regarding the impact of the CTD format on the quality of the review process. Subsequently a face-to-face meeting with the senior personnel from the authorities took place to validate the information provided.

The current situational analysis showed that the six GCC states (Bahrain, Kuwait, Oman, Qatar, Saudi Arabia, and UAE) rely on government funding. Saudi Food & Drug Authority (SFDA) is an independent authority even though 98 % of the funding comes from the government. Five authorities in the GCC region are functioning under the autonomy of their health authorities (Bahrain, Kuwait, Oman, Qatar and UAE). Bahrain has finally been established as an independent authority which is also funded by the government, whilst Kuwait has future plans for having an independent agency, but lacks the political support for this project.

In order to improve the review process, the Gulf states considered adopting the CTD format for their submission and approval process (Table 5.1). The six Gulf states (Bahrain, Kuwait, Oman, Qatar, Saudi Arabia and UAE) are currently accepting the CTD format, and they follow the ICH format with differences in module 1 related to individual country’s administrative details (Table 5.2). The six countries are accepting paper format, whilst four countries are accepting electronic formats as well (Bahrain, Kuwait, Oman, and Saudi Arabia). Qatar and UAE stated that electronic format will be implemented in the future.