Mashaki Ceyhan Emel, Gürsöz Hakki, Alkan Ali, Coşkun Hacer, Koyuncu Oğuzhan, Walker Stuart
Centre for Innovation in Regulatory Science, London, United Kingdom.
School of Pharmacy and Pharmaceutical Sciences, Cardiff University, Cardiff, United Kingdom.
Front Pharmacol. 2018 Jan 25;9:9. doi: 10.3389/fphar.2018.00009. eCollection 2018.
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. 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). 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. 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.
如果在面临共同挑战且卫生机构特征相似的国家之间进行监管机构比较，可能会更有价值并有助于改进。开展了一项研究，将土耳其药品和医疗器械局（Türkiye Ilaç ve Tibbi Cihaz Kurumu；TITCK）使用的注册审查模式与四个规模相近的监管机构的模式进行比较，以确定TITCK在审查过程中的优势领域以及需要进一步改进的领域，并评估其对良好审查规范（GRevP）的遵守程度，以便推动TITCK朝着机构目标前进。TITCK完成并验证了一份调查问卷，以收集与机构组织结构、监管审查流程和决策实践相关的数据。澳大利亚治疗用品管理局（TGA）、加拿大卫生部、新加坡卫生科学局（HSA）和沙特阿拉伯食品药品管理局（SFDA）也完成并验证了类似的调查问卷。TITCK对所有新活性物质（NAS）申请进行全面审查。申请时不需要提交药品证书（CPP）；然而，TITCK最终授权需要另一国家的批准证据。TITCK提交申请时不需要定价数据；然而，必须完成定价以使产品能够上市销售。TITCK的平均批准时间超过了该机构的总体目标时间，这表明在绩效、一致性和流程可预测性方面有改进空间。已经制定了GRevP措施，但TITCK目前尚未正式实施。通过这项研究进行的比较，向TITCK提出了一些建议，包括通过共享其他当局颁发的GMP检查结果和证书来简化良好生产规范（GMP）流程，从而避免当前流程造成的延误；取消事先批准或CPP的要求；与其他类似监管机构进行共享或联合审查；正式实施和监督GRevP；为每个审查里程碑确定目标时间；重新定义定价流程；以及通过编制公开可用的批准依据摘要来提高透明度。
