عنوان

Evaluation of the regulatory review system in Turkey and the development of a new model for improving the approval process

شماره

TLets720903

عنوان اصلي

Evaluation of the regulatory review system in Turkey and the development of a new model for improving the approval process

نام عام مواد

[Thesis]

نام نخستين پديدآور

Mashaki, Emel

نام ناشر، پخش کننده و غيره

Cardiff University

تاریخ نشرو بخش و غیره

2017

جزئيات پايان نامه و نوع درجه آن

Thesis (Ph.D.)

امتياز متن

2017

متن يادداشت

All regulatory authorities share the responsibility for ensuring patients' timely access to new medicines while maintaining quality, safety and efficacy standards. In addition, healthcare decision-makers must consider the cost effectiveness of medicines and the impact on the national budget. The aim of this study was to evaluate the Turkish regulatory review process and approval times from 2012 to 2015 in order to identify the key issues that need to be addressed. The study included a comparison between the Turkish review process and its quality measures with those of other mid-sized regulatory agencies in Australia, Canada, Saudi Arabia and Singapore to determine the strengths and areas for improvement for the TITCK. To put these issues into context, the pharmaceutical industry experiences of the regulatory environment in Turkey was evaluated as well as patients' knowledge and awareness of the country's regulatory approach to the approval and reimbursement of medicines. Thus, the ultimate aim was to develop an improved review model for the TITCK. A standardised questionnaire was completed by the TITCK and the four authorities who provided details of their review process for new active substances (NASs) and the quality measures implemented in their assessment procedures. Metrics for medicines approved between 2012 and 2015 were collected from both the TITCK as well as from pharmaceutical companies. A further questionnaire was developed and completed by two hundred and ten patients and the resulting data were evaluated in a unique study. The comparative study of the TITCK with four comparable regulatory authorities showed that the agency in Turkey conducts a full assessment (Type 3A) for all NAS applications, which is in line with the other mid-sized regulatory authorities, although it does not implement a risk stratification approach. In general, the regulatory requirements in Turkey are aligned with international standards except for certain areas such as the GMP process and pricing. Moreover, the results demonstrated that the approval times in Turkey are longer by two to three months compared to other countries in this study. The TITCK mean approval time for NAS marketing authorisation applications between 2013 and 2015 was three hundred and twenty working days, which exceeded the agency's overall target time of two hundred and ten working days. A similar outcome was identified in the pharmaceutical industry study where the review time was reported to be four hundred and sixty working days and in contrast to the TITCK data this included company response time. Thus, the median time for NASs from first approval in the world to TITCK approval was identified to be approximately three and a half years. This supported the main findings from the patient study that new medicines become available in Turkey later than other developed countries. Finally, an evaluation of the TITCK decision-making process showed that the essential elements of Good Review Practices (GReP) are implemented, although they are not formalised. The key issues from these four studies were reviewed with the TITCK experts during a focused workshop. As a result, a new improved review model for the TITCK was proposed. This model utilises the available resources while providing suggested improvements to enable the TITCK to achieve its overall target approval time for NAS applications in a consistent, transparent and predictable manner. These included optimising the TITCK organisational capacity, aligning their requirements with international standards, streamlining the review process, implementing GReP and a structured approach to the Benefit-Risk assessment of medicines. In this way, patients' access to medicines would be enhanced and the new model would support the goal of the TITCK to become an international centre of regulatory excellence in the region.

موضوع مستند نشده

Q Science (General)

مستند نام اشخاص تاييد نشده

Mashaki, Emel

مستند نام تنالگان تاييد نشده

Cardiff University

نام الکترونيکي

فرمت انتشار

p

نوع ماده

[Thesis]

کد کاربرگه

276903

سطح دسترسي

a

تكميل شده

Y