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.

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Objectives: Contemporary data on cardiovascular (CV) burden in women with type 2 diabetes (T2D) is lacking, particularly in the Middle East and Africa where the incidence and prevalence of T2D is one of the highest globally. We report prevalence of ASCVD/ASCVD risk stratified by gender to identify opportunities for improving T2D care. Methods: PACT-MEA (PACT-MEA; NCT05317845) is a cross-sectional, observational study of adults (≥18 years) with T2D from 55 clinics in Bahrain, Egypt, Jordan, Kuwait, Qatar, South Africa, and United Arab Emirates. Medical history, demographics, clinical information, and laboratory values were collected from medical charts of patients at a clinic visit in 2022. We report the prevalence (95% CI) of established atherosclerotic cardiovascular disease (eASCVD) and ASCVD risk, the latter defined by the 2021 European Society of Cardiology (ESC) Guidelines on CV Disease Prevention in Clinical Practice (risk categories: moderate, high, very high [including eASCVD]). Prevalence estimates were weighted according to the size of the diabetes population in each country. Results: Of the 3,726 patients enrolled, 47% were female, with a median age of 59.0; 35% were <55 years old. Across the seven PACT-MEA countries, prevalence of eASCVD was 16.0% (95% CI: 13.4-18.6) among females and 26.6% (23.7-29.5) among males. Per ESC guidelines, 0.6% (0.0-1.2) of females were at moderate risk for ASCVD, 72.5% (69.0-75.9) were at high risk, and 26.9% (23.5-30.3) were at very high risk. Among males, 0.7% (0.0-1.5), 65.9% (62.4-69.4), and 33.4% (29.9-36.8) were at moderate, high, and very high ASCVD risk, respectively. Conclusions: We found 1 in 6 women with T2D in the Middle East and Africa have eASCVD and nearly all are at high/very high ASCVD risk. This highlights the need for better screening and timely management of T2D in women and men to minimize CV risk, as well as the importance of gender inclusiveness in clinical studies. Disclosure F. Alawadi: Research Support; Novo Nordisk. E. Mashaki ceyhan: None. H. M. Sabbour: Research Support; Novo Nordisk. S. Salek: None. G. Yadav: Employee; Novo Nordisk. S. Verma: Advisory Panel; Amgen Canada, AstraZeneca, Bayer Inc., Boehringer Ingelheim and Eli Lilly Alliance, HLS Therapeutics Inc., Janssen Pharmaceuticals, Inc., Novartis Canada, Novartis, Novo Nordisk, Novo Nordisk Canada Inc., Consultant; AstraZeneca, Other Relationship; Amarin Corporation, AstraZeneca, Bayer Inc., Boehringer Ingelheim and Eli Lilly Alliance, Boehringer Ingelheim International GmbH, Canadian Medical and Surgical Knowledge Translation Research Group, EOCI Pharmacomm, HLS Therapeutics Inc., Janssen Pharmaceuticals, Inc., Novartis Canada, Novo Nordisk, Novo Nordisk Canada Inc., Pfizer Inc., PhaseBio Pharmaceuticals, Inc., S & L Solutions Event Management Inc, Sanofi, Sun Pharmaceutical Industries Ltd., Toronto Knowledge Translation Working Group, Research Support; Amarin Corporation, Amgen Canada, AstraZeneca, Bayer Inc., Boehringer Ingelheim International GmbH, HLS Therapeutics Inc., Novartis, Novo Nordisk, Pfizer Inc., PhaseBio Pharmaceuticals, Inc. S. H. Assaad-khalil: Board Member; AstraZeneca, Merck & Co., Inc., Servier Laboratories, Sanofi, Consultant; AstraZeneca, Servier Laboratories, Sanofi, Merck & Co., Inc., Research Support; Novo Nordisk, Eva Pharma. W. Almahmeed: None. N. Alamuddin: Consultant; Novo Nordisk, Speaker's Bureau; Novo Nordisk. H. Alkandari: None. J. A. Haddad: None. L. N. Husemoen: Employee; Novo Nordisk A/S, Stock/Shareholder; Novo Nordisk A/S. L. Lombard: None. R. A. Malik: None.

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