Building Quality into the Regulatory Review Practice for Competent Authorities

Abstract

The aim of this chapter is to discuss how competent authorities build quality into their assessment and registration process of medicines and to address possible challenges and opportunities for timely access to safe, effective, and high-quality medicines. Details of quality attributes which characterize the extent of scientific assessments will be the main focus. Such attributes will require solid quality management tools in place the for establishing and maintaining a proper regulatory system. Global harmonization of the regulatory review processes was achieved by the introduction of the Common Technical Document (CTD) which was developed by the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) as the tool for improving the quality of the regulatory review process by standardizing the documents and specifications in the product registration dossier to minimize variations in the of assessment practices and drug approval timelines. Now, with the growing global demand for medicines and the challenges that contribute to drug shortages around the world calls for re-evaluating the impact of CTD/eCTD on the availability of medicines in a no-delay timely man-ner. Therefore, key quality measures must be evaluated to further harmonize and improve the speed and outcomes of the regulatory review process.

1. Introduction

Drug regulations have evolved over the last five decades in response to challenges facing the discovery development, production and distribution of pharmaceutical products. The early regulatory standards were mostly focused on guaranteeing the quality standards of the medicines, However, subsequent developments in the early 1960s led to the recognition of new standards for evaluating the safety and efficacy of new pharmaceutical products [1].

Nowadays, more challenges have occurred, mainly after the COVID-19 pandemic, which burdened the regulatory authorities around the world to meet the demand for medicines and their shortages which forced the regulators to seek other strategies to speed up the approval timelines for essential medicines without affecting their quality, safety and effectiveness. Such challenges added another impediment related to the submission of registration dossiers in the form of Common Technical Documents (CTD) and electronic Common Technical Document (eCTD) which was first adopted over two decades ago in the European Union (EU) and Japan and was the strongly recommended format for New Drug Applications (NDAs) submitted to the United States Food and Drug Administration (USFDA) to harmonize the review process around the world and to embrace the quality measures and a timely access to safe and effective medicines [2]. Therefore, building quality into the regulatory review process is important for the establishment and implementation of effective strategies to monitor the quality, minimize deficiencies and ensure reliable and timely access to safe and effective medicines [3]. However, a quality review requires regulations that are both broad and flexible to address general and specific regulatory issues [4].

In the field of pharmaceutical regulations, a pharmaceutical product can either be an investigational or a marketing application product. An investigational product refers to a therapeutic product (pharmaceutical or biological medicine), a medical device, a diagnostic, a palliative or preventive treatment (vaccine) used in clinical trial.

A marketing application is an application submitted to the regulatory authority to obtain marketing authorization for a pharmaceutical product which has not yet been approved.

The three components considered for the regulatory review process in any application are CMC, nonclinical and clinical studies. The CMC of a finished product plays an integral part in the adequate implementation of the non-clinical and clinical studies, enabling accurate analysis and association between the results obtained in each stage of the drug discovery and development process, enabling nonclinical and clinical studies and reducing a product’s time to market. Efficient planning and long-range product and regulatory strategies can have lasting impacts on overall lifecycle management [5].

‘Quality’ is normally related to the concept of ‘fitness for use’ of the pharmaceutical product which meets its pre-specified quality attributes or CMC specifications [6].

Increasingly, however, ‘quality’ is not only being used to measure the standards of the pharmaceutical characteristics but also the drug regulatory process itself. The quality of the process, from the construction of the CTD and eCTD to the ultimate regulatory decision must also be monitored [7].

This chapter provides an overview of the measures used to build quality into the regulatory review process addressing aspects of their Good Review Practices (GRPs).

2. Defining the regulatory review quality measures

The quality measures addressed in this chapter are qualitative tools that are used to evaluate and compare the quality of the review process according to standards and benchmarks that are used to improve the competency, consistency, transparency, timeliness of the drug approval procedures [8]. The constantly changing regulatory environment requires continuous and regular optimization of efficiencies and competencies in the regulatory systems, implementing multinational endeavours to characterize assessment procedures and metrics associated with the regulatory approval systems [9].

Furthermore, solid data must always be in place identifying the milestones and overall approval times for all products from the time of submission of the registration dossier to the time of the approval of the new medicine.

Guidelines, standard operating procedures, and review templates are the building blocks for good review practices (GRP) in addition to other measures which also have an impact on the quality of the review process such as having a formal framework to apply quality decision-making practices.

Quality measures may be evaluated on a regular basis to determine their impacts on the quality and speed of the drug approval process. Timelines must be realistic, achievable and in line with the currently existing resources. Review of the human resources and the workload must always be assessed and updated according to the needs, challenges and opportunities for improving the regulatory review practices. Using the ‘regulatory stop watch’ to separate between the authority and the company time when setting and measuring targets is critical for both parties. The study templates should always be evaluated and improved to speed up the review process while sustaining the benefit-risk framework used for the review process adopted by the authority.

This chapter will address the general measures used to achieve quality of the review process which include tools such as communication, training and education, and transparency [8]. The chapter will also assess the drivers and barriers to achieving a quality review. An overview of the measures that determine the quality of the review process is expressed using the balance scorecard as the tool for managing the performance and outcomes of the regulatory review process [3].

3. General measures used to achieve quality

In order to build the quality of the regulatory review process, six quality measures should be considered, namely, joint and shared review (JR/SR), peer review (PR) (external and internal), assessment templates, standard operating procedures (SOPs), Good Review Practice (GRP), and a Quality Policy (QP) [3]. These are the basic measures, but other measures may be added according to the needs and challenges encountered due to the evolving regulatory environment. However, for each regulatory authority to achieve the best standards for the review practice they need to conduct a SWOT analysis to determine the strengths, weaknesses, opportunities and threats, focusing on the six quality measures stated above and pinpointing areas that require improvement in the regulatory practices.

3.1 Quality policy (QP)

QP is the overall intention and direction of an organization related to quality as formally expressed by top management. It aims to improve the performance of the reviewers, to establish whether the outcome of the review process is acceptable and whether the registration procedure fulfills the desired quality standard [3].

Therefore, in order to improve the speed and quality of the regulatory review process, consistent and continuous progress and developments musts be warranted while at the same time ensuring regular measurement and monitoring of the metrics and the outcomes of the review process addressing actions to be taken to further improve it.

3.2 Good review practice (GRP)

GRP is a documented best practice which discusses the aspects related to the process, format content and/or management of a product review. It is considered as a code for review procedures that aims to standardize and improve the overall documentation and ensure timeliness predictability, consistency and best quality reviews and review reports [8].

In order to build the quality of the review process, each authority should assess their needs and develop its own GRP for the following objectives [10]:

• The GRP is developed over time as a guideline for the best standards of review practice based on experience, and should accomplish consistency to the overall review process of new medicines.

• The GRP is developed to build quality into the regulatory review process and to improve the management tools of the review system.

• The GRP is developed to achieve better efficiency, clarity and transparency of the review process

• The GRP is developed to be adopted by the regulatory reviewers as standard procedures for the review practice which require formal training and supervised mentoring to ensure the achievement of the target metrics and outcomes.

3.3 Standard operating procedures (SOPs)

This measure is defined as the formal documents that clearly and accurately describe how an individual or organization should be performing a certain task. The purpose of a SOP is to carry out the procedures correctly and always in the same manner and should be available at the place where the work is done [3].

At regulatory authorities, reviewers use SOPs as a guidance for their scientific assessments of the registration dossiers. SOPs are revised and updated regularly according to the needs of the system and changes in the regulatory affairs and approval requirements around the world. It should always be considered as the official reference document for all reviewers, juniors or seniors, and must be readily available whenever needed. Furthermore, all appointed reviewers should be read and understand the latest version of the SOPs to achieve consistency and sustainability of the desired standards of the review practice.

3.4 Assessment report templates

Assessment templates are documents used to produce reports on the scientific review of a new active substance (NAS) for a new drug application (NDA) and an existing active substance (EAS) for an extension drug application (EDP). They provide general guidance on the evaluation of the quality, non-clinical and clinical aspects of the application [11].

Reviewers should always use an assessment template to guide their review of the registration dossier. These templates are an important quality measure that set out the content and the format of the written scientific assessment reports [8].

Assessment templates produce two types of reports:

1. Regulatory assessment reports: These are the assessment reports generated from the scientific review of the registration dossier submitted to the authority to apply for the regulatory approval of a new drug application (NDA) and an extension drug application (EDA).

2. Public assessment reports: These are published reports for every human or veterinary medicine application that has been granted or refused a marketing authorization. These types of reports follow the scientific assessment of an NDA or EDA submitted by the pharmaceutical company by the dossier registration in the format approved by the competent authority (CA) [12].

Assessment report templates coupled with SOPs form an essential component for implementing GRP.

3.5 Peer review (PR)

Peer review is an important quality measure that requires evaluation of the assessment reports by one of two persons with similar competencies to the scientific reviewer (peers). It functions as a form of self-regulation by qualified members of the regulatory profession within the review practice area. It can be implemented by establishing an internal scientific committee that evaluates the reviewer’s assessment reports consisting of multidisciplinary members that evaluate each discipline of the assessment report produced by the scientific reviewer.

In addition, some CAs may carry out external peer reviews to verify that the assessment report produced by the scientific reviewer is of the desired quality and produces valid outcomes according to the data submitted in the registration dossier. This quality measure provides credibility and integrity of the review process and ensures validity and reliability of the assessment reports. However, it should be managed carefully within a reasonably monitored timelines to prevent delays in the access of medicines to patients in need. In certain cases, peer reviews may not be necessary especially for EDAs as the competency and qualification of experienced reviewers will be sufficient to grant the regulatory approval for an EAS by the registration committee that makes the final approval decision if the assessment report shows a positive outcome.

3.6 Shared/joint reviews

A shared review (SR) is the process of assigning each part or discipline within the regulatory system to the relevant expertise. For the process of medicinal product dossier review, this approach may be achieved by collaborative efforts between two or more CAs where each country is responsible for part of the registration dossier and the decision is issued to grant- or refuse to grant—the marketing approval for the product when the results are reported with recommendations to the decision-making entity (committee or person-in-charge). For example, EMA member states share expertise in the assessment of new medicinal product, relying on each other for exchange of information about the regulation of medicines [13].

Joint reviews (JRs) are usually performed jointly by several the authorities on the same application as part of a centralized regulatory system such as the one adopted by the Gulf Cooperation Council (GCC) Health Council the East African Community (EAC) [8, 14]. The Gulf States adopted the joint review initiative where the same product registration dossier is reviewed by several GCC member states. Furthermore, and the same idea have been embraced by the seven EAC countries. Therefore, a joint review is a procedure where the whole dossier is reviewed by each authority and the outcome is discussed before the decision is taken by agreement between the member states [14]. In a shared review, however, each authority takes responsibility for reviewing a separate part of the dossier.

3.7 Quality management system (QMS)

A QMS is a set of coordinated activities to direct a competent regulatory system towards improving the efficiency of its performance. It is designed and implemented to emphasize continuous improvement of the regulatory compliance and to achieve the desired outcome by making quality, safe and effective medicines readily available for patients in need [3].

QMS tools simplify the regulatory processes. They are designed to automate and integrate all quality measures and activities and to align quality across the product regulatory life cycle from the time of submission of the application for marketing approval until the time after it has been consumed by the patient where the expected clinical effect shall be met when the benefits experienced by the individual patient as well as those experienced by the society from consuming the product outweigh its individual and societal risks. QMS tools streamline processes like document control, training, risk management, Lab quality control procedures, as well as the review process to produce solid and reliable data and outcomes that improve the quality of the regulatory decision-making process.

3.8 Quality audits and feedback

Competent authorities implement several measures for continuous improvement including quality audits and feedback activities. Internal audits typically involve the organization internally auditing different units or processes. External audits are normally carried out by accredited certification bodies or external authorities, e.g., the International Organization for Standardization (ISO), the European Foundation for Quality Management (EFQM), WHO-Listed Authority (WLA). These quality audits are essential to provide the competent authority with the feedback required to improve the quality of the review process [3].

A quality audit is an essential element of Total Quality Management (TQM). It is the process of systematic and periodic on-site verification with documented examination of activities, records, practices and other components of a quality system to evaluate its degree of compliance to requirements of a standard specifications [15] such as ISO standards, Good Manufacturing Practice (GMP), Good Review Practice (GRP), Good Laboratory Practice (GLP), Good Pharmacovigilance Practice (GPvP) and Good Documentation Practice (GDocP).

In addition, it is a good practice to conduct ‘post-approval’ discussions with the pharmaceutical company to provide feedback on the quality of the dossier and obtain the company’s comments and responses about areas of concern raised by the scientific reviewer [8]. This is a critical practice to exchange constructive feedback between the two parties for the benefit of the review outcome.

3.9 Quality assurance infrastructure

Quality is defined in a general term as ‘fitness for us, focusing on compliance to regulatory requirements, conformance to obligations, and pursuit of merit and superiority’. Quality assurance (QA) is the part of the QMS focused on providing confidence that quality requirements will be fulfilled. Such confidence provided by QA is twofold: internal management of the regulatory systems, including the regulatory review process, and externally to pharmaceutical companies, external regulators, other competent authorities, certifiers and third parties [16].

An alternative definition of QA is ‘all the planned systematic activities implemented within the quality system that can be demonstrated to provide confidence that a product (e.g., new drug) or service (e.g., regulatory review process) will fulfil requirements for quality’ [16].

Quality control (QC) is a process-oriented approach that focuses on fulfilling the quality requirement and aims to identify and rectify defects in the final product. It encompasses techniques and procedures undertaken within the quality assurance to verify that the requirements for quality have been met [17]. It involves inspecting, testing and evaluating the process or the product to ensure it meets the required standards. While QA relates to how a process is performed or how a product is made, QC is more related to the inspection/audit aspects of the quality management.

An alternate definition is ‘the operational procedures and activities that fulfil the requirements of quality’.

QA infrastructure includes the QC procedures that focus on the product quality defects and require immediate actions to fulfill and maintain the quality standards. QA is part of the QMS while QC is part of the QA system (Figure 1).

Figure 1.

Quality system, quality assurance and quality control relationships.

Quality assurance should not be limited to assessment and review process but should covers all aspects of the regulatory system, medical practice and licensing.

4. Scientific committee procedure

Committees are a necessary aspect of organizations of any significant size. They formally draw together people of relevant expertise from different parts of an organization to share information and coordinate activities resulting in the widening of viewpoints and sharing of responsibilities [18]. A scientific committee involves members from multidisciplinary specialties relevant to the modules and sections presented within the registration dossier. The committee members discuss their opinions according to their expertise and share their professional insights that improve the decision-making through interactions and contribute to the committee’s final recommendations and decision outcomes made by consensus. Furthermore, a scientific committee offers an opportunity for a group problem-solving and can be a medium for generating multiple ideas and by addressing a problem from various angles to come up with the best solution.

Regulatory authorities that depend on individual reviewers and decision-makers may not have the opportunity of sharing multiple viewpoints and ideas. Therefore, their decision-making process may rely on one person’s thoughts and views which may lack critical insights and perspectives which may impact the final decision. The scientific committee should be the last part of the regulatory review process, being responsible for assessing the applications and generating the final approval decision. In some regulatory systems, one scientific committee exists that discusses the scientific assessment reports and generates the final decision to grant or refuse marketing authorization of the product e.g., GCC central registration committee. In other authorities, separate scientific committees exist for each area e.g., stability, quality control, GMP, Bioequivalence studies, minor variations and internal peer reviews, and external screening committee such as in UAE and Saudi Arabia [8]. All reports of the scientific committees are then discussed in the higher registration committee after the scientific committees have given their opinions and the higher registration committee makes the final approval decision [18].

4.1 Information technology (IT) infrastructure

Saudi Arabia was the first authority in the region that placed considerable efforts and resources on applying IT systems to improve the quality of the review process such as electronic tracking systems [19]. Other GCC regulatory authorities are working their ways though the system to establish an IT infrastructure that will have a positive impact on the speed, quality and efficiency of the review process. A CA seeks to implement an automated regulatory system for registration and follow-up of applications, ensuring that all the technical data (administrative, quality, nonclinical and clinical) of a pharmaceutical product are in compliance with the terms of the authorization. Furthermore, CAs approve products based on data and documents submitted at all stages of drug development from discovery to final regulatory approvals, The IT infrastructure is critical to achieve quality of the review process because it could help speed up the system by eliminating lengthy tasks and procedures for collecting, organizing and handling data from records, in addition to minimizing the human intervention in the documentation process [20]. Moreover, having an electronic system which signals delays in the review process is an important tool to control and monitor the approval timeline for pharmaceutical products [3].

Even though these facilities are available in many regulatory systems, e.g., EMA and USFDA the sophistication and the know-how of the system can differ between the various authorities [21].

4.2 Communication as a quality measure

Communication is an important aspect at any level of quality management. It plays a critical role in developing and managing any task or project. By effectively communicating information about tasks, policies, procedures, and expectations, leadership at the CA can help ensure that all regulators are on the same page and working together towards common goals for ensuring and sustaining the availability of quality, safe and effective medicines. Furthermore, communication is crucial for identifying and addressing quality issues in a timely manner.

Traditional methods are still undertaken by many CAs for communicating official policies, guidelines, memoranda and regulations to the industry using direct ‘letter of request’ submitted to the CA manually or electronically [19]. Some CAs (e.g., EMA, MHRA, FDA, Saudi FDA, etc) communicate official guidelines through their website which is the most convenient method for the companies.

In general, any form of communication is considered essential for the speed and quality of the regulatory review outcomes. Formal contact through scheduled meetings and official letters as well as communications through telephone conversations, SMS messages or WhatsApp messages, emails or less commonly-faxes may occur between pharmaceutical companies and authorities. The importance of effective communication between the regulators and industry cannot be overemphasized for successful and timely completion of the review process, which is particularly useful when pre-submission advice is required by the pharmaceutical company to understand the registration requirements to grant the final approval for their pharmaceutical product. Furthermore, a rational practice can be achieved when effective and transparent communication is enhanced between the pharmaceutical company and the CA. However, some authorities apply restrictions on their staff to prevent the culture of corruption from creeping into the system, and hence such authorities limit any official communication to the leadership and supervisory levels.

4.3 Training and continuous professional development

Regulatory systems cannot operate efficiently and effectively without training and comprehensive professional development programmes. Regulatory reviewers at CAs as well as the regulatory compliance personnel at the pharmaceutical industry should be equally knowledgeable and highly skilled in reviewing all parts of the registration dossier. Training could be in-house where the reviewer receives training on newly assigned duties and tasks or on changes and updates to existing ones. On the other hand, training could be received externally, either by seconding the reviewer to another authority/institution for a certain period of time to gain knowledge and insights while experiencing a different work environment, or by motivating and encouraging attendance of external professional and educational programmes and events to widen the employees’ views and perspectives and expand their knowledge and skills. Ideally, after training or attending a course, the reviewer should report his/her experience or knowledge to colleagues and top managers and propose changes and improvements to existing procedures or the adoption of new practices to improve the overall performance of the reviewing staff. Proficiency test should be applied to evaluate the reviewer’s competency level and to ensure that the required knowledge and skills have been achieved [8].

Training can help regulators achieve quality goals from their timely review process and efficient quality control analysis. This will reflect on the satisfaction of the patients that are able to access high quality, effective and safe medicines, as well as the satisfaction of the pharmaceutical companies that are required to fulfill the regulatory requirements efficiently and transparently.

Training is an essential quality assurance element that should be established in any CA to develop and improve processes to ensure that the final decision outcomes meet a set quality standard. Therefore, regulators should not only receive training on how to review registration dossiers or how to conduct quality control laboratory analysis, but also on quality assurance training to help all employees better understand and improve the quality of their work at all regulatory levels, policies and procedures.

4.4 Transparency as a quality measure

Transparency is an art, and leading with transparency means honoring commitments even when there are difficult decisions to be made. Regulators should be acquainted with ways to be open and honest with their colleagues and peers as well as clients, avoiding unnecessary conversations and only sticking to sharing information that best supports the future regulatory decisions that ultimately benefit the health of individuals as well as the public [22]. Transparency ensures that the review process is moving ahead towards the desired regulatory goals and producing the quality standards that are acceptable to all stakeholders. This is considered essential for establishing a relationship between the regulatory authority and other parties which is based on trust, confidence and professionalism of regulators, professionals, and the industry [8].

Transparency is an element of quality that offers no tangible incentive, but impact the CA in a positive way because it builds trust in the system, drives staff engagement and support, enhances innovation through knowledge sharing, ensures better performance, enhances collaborative attitude and encourages cooperative efforts. Furthermore, transparency builds confidence, ensures ethical conduct of the regulatory procedures and enhances the reviewer’s proficiency in performing tasks and duties.

4.5 Monitoring drivers and barriers to good review practice

The most important reason for the introducing quality measures into the regulatory review process is to bring about improvement in the approval timeline while ensuring the quality, safety and effectiveness of the approved medicines. Furthermore, quality measures are adopted to minimize errors while ensuring precision, accuracy consistency and efficiency in producing the desired outcomes.

Understanding the drivers and barriers to achieving good review practice (GRP) can promote innovation and creativity while introducing new policies and procedures to help reviewers assess new medicines more efficiently and at the same time monitoring the quality of the review process and evaluating the quality of decisions made by the CA accordingly.

Drivers and barriers to the regulatory review process can be determined by three factors that contribute to its effectiveness and efficiency and can impede opportunities for making new medicines available in a timely manner. Each CA can assess its own drivers and barriers to quality based on the country’s distinctive regulatory environment, its unique political situation and the governmental level of autonomy. In general, one of the major barriers identified in advanced regulatory authorities is shortages in regulatory affairs professionals and human resources when compared to projected needs for in the fields related to regulatory science [23].

5. Building quality into the regulatory review process

Having long review timelines does not necessarily imply poor performance level. Quality management tools and practices was proposed by an Empirical study which conducted in Jordan to propose organizational performance and received substantial attention in many researches [24]. Therefore, in order for the CAs to build quality into their regulatory practices, they need to create a balance between four quality assurance attributes, namely, quality measures, quality management tools, training and continuing professional development and transparent communication. This can be achieved using a balanced scorecard framework shown in Figure 2.

Figure 2.

Balanced scorecard framework for the types of quality measures and activities adopted by competent authorities (CAs). Source: Template adopted from [8].

Quality measures are the first aspect in the proposed balanced scorecard framework which are considered essential practices for ensuring consistency, accuracy, competency and efficiency of the review process such as SOPs, assessment templates, GRPs, internal and external peer reviews, shared and joint reviews [18].

These can be secured if the CA has an independent QA department. Furthermore, CAs need to focus their efforts on using quality management tools more efficiently and effectively to achieve the most desired outcomes by the managerial and technical staff [25]. These activities include evaluating stakeholders’ and reviewers’ feedback, providing technical advice to the pharmaceutical companies on the submitted dossier, carrying out internal and external audits and establishing an electronic tracking system for monitoring the approval process (Figure 2).

Training and continuing professional development (CPD) programmes involve engaging expertise in association with the CAs’ staff to improve the quality of their assessment through knowledge and skill transfer [26].

These programmes are critical for efficient regulatory systems because they motivate the employees to be efficient and productive. They assist them in adopting new technologies and interventions, and at the same time helps them effectively manage staff turnover and enhance creativity and innovation. This can be achieved by conducting formal training programmes for reviewers, providing placements and secondments to external CAs, attending professional development courses and post-graduate programmes and carrying out in-house and/or on-the-job training (Figure 2) [3]. Finally, transparency and effective communication have several advantages. They build a strong rapport between the pharmaceutical industry and regulatory authorities, enhances knowledge-based practice, supports informed decisions, and optimizes the utilization of resources, strengthens the employees’ trust and job satisfaction, reduces turnover and prevents confusion, misinformation and disinformation-related critical regulatory issues. Furthermore, utilizing quality measures build trust in the system improves knowledge sharing, maintains follow-up and increases productivity and predictability of outcomes [27]. Open discussion and negotiation skills provide valuable pre-submission advice to utilize practical methods that allow better convenience and accessibility of information related to the high-quality drug approval procedure. Post-approval communications between the pharmaceutical industry and the CA is also critical to ensure sustainability of the quality, safety and effectiveness of the pharmaceutical product through the future application of improved regulatory review of future product dossiers by boosting the reviewers’ knowledge and skills in the assessment process and by enhancing the confidence of the regulatory system to perform more efficiently and effectively [18].

6. Conclusion

Stringent regulatory authorities focus on the quality of the review process performed to build confidence in the drug approval system. To achieve this goal, CAs ensure the implementation of effective communication and cooperation as well as consideration of drivers for continuous advancement that fulfills the desired quality measures in the regulatory system. Therefore, CAs are required to adopt a standardized assessment template to evaluate the registration dossiers supported by SOPs to avoid lengthy timelines, to eliminate duplicate efforts and minimize variations between the assessment practices. However, to further improve the performance of good assessment practice, the authorities should apply continuous education and CPD programmes as well as adopt external quality audits from accredited certification bodies for evaluating the maturity of the regulatory system which aim at enhancing the evaluation process of the registration dossiers. Moreover, the electronic tracking system should also be adopted as a quality management tool to manage the review milestones and regulate the speed and quality of the approval system. Finally, CAs can achieve the desired quality of the review process when they thrive to improve transparency during their collaborations with the relevant stakeholders, namely, the pharmaceutical industry, healthcare professionals, patients and external peers to build trust and confidence in the pharmaceutical regulatory system.

Abbreviations

CA	Competitive authority
CMC	Chemistry, Manufacturing, Control
CPD	Continuous Professional Development
CTD	Common Technical Document
EAC	East African Community
EAS	Existing Active Substance
eCTD	Electronic Common Technical Document
EDA	Extension Drug Application
EFQM	European Foundation for Quality Management
EMA	European Medicines Agency
EU	European Union
GCC	Gulf Cooperation Council
GDocP	Good Documentation Practice
GLP	Good Laboratory Practice
GMP	Good Manufacturing Practice
GPvP	Good Pharmacovigilance Practice
GRP	Good Review Practice
ICH	International Council for Harmonization of technical Requirements for pharmaceutical Products for Human Use
ISO	International Organization for Standardization
IT	Information Technology
JR	Joint Review
KDFC	Kuwait Drug and Food Control
MHRA	Medicines and Health Regulatory Authority
NAS	New Active Substance
NDA	New Drug Application
PR	Peer Review
QA	Quality Assurance
QC	Quality Control
QMS	Quality Management System
QP	Quality Policy
Saudi FDA	Saudi Food and Drug Authority
SMS	Short Message Service
SOP	Standard Operating Procedure
SR	Shared Review
TQM	Total Quality Management
UAE	United Arab Emirates
US FDA	United Stated Food and Drug Administration