A cross-sectional study of the prevalence and clinical management of atherosclerotic cardiovascular diseases in patients with type 2 diabetes across the Middle East and Africa (PACT-MEA): Study design and rationale.

AIM: To investigate the epidemiology and clinical management of patients with type 2 diabetes (T2D) and established atherosclerotic cardiovascular disease (eASCVD) or high/very high ASCVD risk, defined by the 2021 European Society of Cardiology Guidelines, in seven countries in the Middle East and Africa (PACT-MEA; NCT05317845), and to assess physicians' attitudes and the basis for their decision-making in the management of these patients. MATERIALS AND METHODS: PACT-MEA is a cross-sectional, observational study undertaken in Bahrain, Egypt, Jordan, Kuwait, Qatar, South Africa and the United Arab Emirates based on a medical chart review of approximately 3700 patients with T2D in primary and secondary care settings, and a survey of approximately 400 physicians treating patients with T2D. RESULTS: The primary and secondary objectives are to determine the prevalence of eASCVD and high/very high ASCVD risk in patients with T2D. Current treatment with cardioprotective antidiabetic medication, the proportion of patients meeting the treatment criteria for reimbursement in the study countries where there is an applicable reimbursement guideline, and physician-reported factors in clinical decision-making in T2D management, will also be assessed. CONCLUSIONS: This large cross-sectional study will establish the estimated prevalence and management of eASCVD and high/very high ASCVD risk in patients with type 2 diabetes across the Middle East and Africa.

Patients' Perspectives of the Pharmaceutical Regulatory and Reimbursement Systems in Istanbul, Turkey.

INTRODUCTION: The aim of this study was to explore patients' knowledge and perspectives in Istanbul, Turkey about the pharmaceutical regulatory review and reimbursement processes with respect to patients' access to new medicines. METHODS: For the purpose of this study a tailored made paper-based questionnaire, Patient Perspective Questionnaire (PPQ), was developed and subsequently piloted in the target population. A total of 350 patients were recruited consecutively into the study from hospital outpatient clinics, general practice, community pharmacies, patient organisations in 28 different districts of Istanbul receiving treatment for chronic conditions. In addition, 22 patients were randomly selected from the cohort for face-to-face interviews in order to obtain further insights about the relevance of the PPQ, and to help with formalising a set of recommendations for the involvement of patients in both processes. Data processing and analyses were carried out using SPSS version 23 statistical software. RESULTS: Overall 210 (60% response rate) completed the PPQ (51% males) with the mean age of 56, median of 54 and range of 18-75. Most patients in this study (84%) seemed to know that medicines had to be approved by the government. However, 81% of patients were not aware of the regulatory review process with 73% being unaware of approval timelines. Furthermore, 78 (37%) patients described the Turkish approval process to be of a lower standard compared to that of the US and EU. However, 147 (70%) of patients believed that there are novel alternative medicines for their disease available in other developed countries. Similarly, 126 (60%) patients thought that new medicines only become available in Turkey after their availability in the other developed countries. In contrast, patients in this cohort were more aware of the reimbursement system in Turkey where the majority expressed their satisfaction and 34% described access to new medicines to be adequate. In addition, the majority of patients (75%) recognised that the government is the main payer, even though insufficient information is provided about new medicines. Patients stated that they do not have any role in the decision-making process for the approval or reimbursement of new medicines and therefore most of them indicated that they wish to be more involved in reimbursement (60%) as well as in the approval process (58%). DISCUSSION: Faster access to medicines, improved health and pharmaceutical care as well as lower prices were considered by the study patients as the improvement priorities. Further, they were able to offer academic collaboration and active patient involvement in both processes as possible solutions.

Evaluation of the Performance of the Turkish Regulatory Agency: Recommendations for Improved Patients' Access to Medicines.

BACKGROUND: This study was to evaluate the Turkish regulatory review process and timelines between 2016 and 2018 with a view to assess the changes that had taken place since the previous study, which evaluated the Turkish review processes and timelines 2013 to 2015. METHODS: Data related to the Turkish Medicines and Medical Devices Agency (TITCK) organizational structure and general information were collected from publicly available sources. A standard questionnaire was then used to collect data with the aim of identifying the TITCK's review practices and key milestones for the marketing authorization process. Subsequently, a comparison with the previous study was conducted to identify the key changes and developments that had taken place from 2015- 2018. RESULTS: The TITCK has made considerable efforts to improve its regulatory capacity since 2016, which has contributed to the overall decrease in the agency review times. The overall median approval time for new active substances; however, increased from 529 calendar days (2016) to 663 calendar days (2018), with the review time in the agency decreasing from 408 calendar days to 326 calendar days, while the company time increased from 137 to 268 calendar days, respectively, over this period. CONCLUSIONS: For the TITCK to become an international reference agency, they will need to fully implement good review practices and a structured framework for benefit-risk assessment and decision making; consider implementing verification and abridged reviews based on a reliance model and expedite the PIC/S mutual recognition process as well as become a full member of the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH).

The Turkish Medicines and Medical Devices Agency: Comparison of Its Registration Process with Australia, Canada, Saudi Arabia, and Singapore.

Introduction: Regulatory agency comparisons can be of more value and facilitate improvements if conducted among countries with common challenges and similar health agency characteristics. A study was conducted to compare the registration review model used by the Turkish Medicines and Medical Devices Agency (Türkiye Ilaç ve Tibbi Cihaz Kurumu; TITCK) with those of four similar-sized regulatory agencies to identify areas of strength and those requiring further improvement within the TITCK in relation to the review process as well as to assess the level of adherence to good review practices (GRevP) in order to facilitate the TITCK progress toward agency goals. Methods: A questionnaire was completed and validated by the TITCK to collect data related to agency organizational structure, regulatory review process and decision-making practices. Similar questionnaires were completed and validated by Australia's Therapeutic Goods Administration (TGA), Health Canada, Singapore's Health Science Authority (HSA), and the Saudi Arabia Food and Drug Administration (SFDA). Results: The TITCK performs a full review for all new active substance (NAS) applications. Submission of a Certificate of Pharmaceutical product (CPP) with an application is not required; however, evidence of approval in another country is required for final authorization by the TITCK. Pricing data are not required by the TITCK at the time of submission; however, pricing must be completed to enable products to be commercially available. Mean approval times at the TITCK exceeded the agency's overall target time suggesting room for improved performance, consistency, and process predictability. Measures of GRevP are in place, but the implementation by the TITCK is not currently formalized. Discussion: Comparisons made through this study enabled recommendations to the TITCK that include streamlining the good manufacturing practice (GMP) process by sharing GMP inspection outcomes and certificates issued by other authorities, thus avoiding the delays by the current process; removing the requirement for prior approval or CPP; introducing shared or joint reviews with other similar regulatory authorities; formally implementing and monitoring GRevP; defining target timing for each review milestone; redefining the pricing process; and improving transparency by developing publicly available summaries for the basis of approval.