The final article of the cycle provides clarifications regarding the remaining specific aspects addressed in the document, finalizing the overview of the existing legal framework and highlighting the key points to be taken into consideration by the parties involved.
Table of content
The Tanzania Medicines and Medical Devices Authority (TMDA), a country’s regulatory agency in the sphere of healthcare products, has published a guidance document dedicated to good review practices for the regulation of medical devices. The document provides an overview of the existing legal framework, as well as additional clarifications and recommendations to be taken into consideration by the parties involved in order to ensure compliance with the relevant regulatory requirements.
At the same time, the authority reserves the right to make changes to the guidelines and recommendations provided therein, should it be reasonably necessary to reflect corresponding amendments to the underlying legislation or changes to the respective principles.
Critical Thinking During Review
According to the document, critical thinking is essential in the review process, requiring an objective and systematic approach to analyzing information and problem-solving. It depends on the collection of data and evidence-based decision-making rather than relying on personal experience, intuition, or trial and error. Decisions should be reproducible and clearly understood by others.
The Authority further acknowledges that every regulatory decision, however, involves judgment. Therefore, core competencies in public health and bioethics, along with the ability to integrate up-to-date scientific knowledge with an understanding of evidentiary standards for regulatory action, including the flexibility inherent in those standards and regulations, guide these decisions.
Regulatory experts, beyond their professional qualifications, critically appraise the information presented in an application rather than accepting it at face value. This skill is developed and strengthened through training and routine quality assurance.
The review focuses on important issues within the application, prioritizing “need to know” information over “good to know” data that does not ultimately affect the outcome of the process. Good judgment is required to ensure balanced decisions, which includes using internationally harmonized regulatory requirements and adopting flexible regulatory approaches to maximize public health benefits while minimizing adverse, unintended consequences.
Factors Influencing Regulatory Decision-Making
According to the guidance, regulatory decisions and recommendations are influenced by several factors:
- Best Available Scientific Evidence and Knowledge: Decisions are grounded in the most current and robust scientific data.
- Public Health Needs of the Country: Consideration of the specific health challenges and priorities within the country.
- State of the Healthcare System: Understanding the capabilities and limitations of the healthcare delivery system may affect regulatory decisions.
In some cases, considerations of the healthcare delivery system may necessitate changes in the scheduling of particular medical devices and in-vitro diagnostics or even refusal of registration for a device that meets quality, safety, and performance standards due to the potential for misuse. When deciding to grant marketing authorization, the benefits must outweigh the risks based on sound scientific evidence.
Assessors provide the scientific rationale for decision-making within the assessment report while considering regulatory requirements. This documentation ensures the integrity of the review process and serves as the decision-making document used by the Authority to make final recommendations.
It addresses dissenting, evidence-based views and clearly identifies the information that was considered.
Communications
Effective communication is critical and offers numerous advantages for the Authority, stakeholders, and the general public. Clear and timely communication enhances the efficiency of the review process, enabling faster access to important medical products.
The Authority actively communicates with its stakeholders through the official TMDA website. Changes made or new requirements introduced are conveyed to applicants via public announcements, website updates, or emails.
The aim is to provide insight into the Authority’s current thinking and expectations, allowing applicants to submit better quality applications. Additionally, new guidelines, regulations, and regulatory requirements are shared with stakeholders for comments before implementation.
This ensures that the requirements are mutually agreed upon and understood, thus improving compliance. Open communication ultimately enhances the efficacy of the assessment process, allowing patients faster access to medicines.
Review processes are conducted in a collaborative environment that requires expertise from different sections within the TMDA. This collaboration is fostered throughout the device’s life cycle.
Regulatory decisions are regularly communicated to other key players within the Authority for implementation. Section 5 of the Act outlines the main functions the Authority should execute, including collaborating and cooperating with other national and international organizations.
Consequently, the Authority engages with other government institutions and international organizations to obtain expert opinions and share information regarding regulated products. The Authority may also engage other National Regulatory Authorities (NRAs) on various regulatory-related issues to facilitate greater regulatory convergence.
Communication with individual applicants throughout the review process can occur through official letters, online application notifications, telephone calls, and emails—the latter being used for minor clarifications and requests.
These communications aim to:
- Foster Efficient Medical Product Development: Provide scientific advice to streamline development processes.
- Increase Applicants’ Understanding: Help applicants comprehend evolving regulatory expectations in a changing medical and scientific environment.
- Enhance the Authority’s Understanding: Gain insights into the challenges and trade-offs applicants face with various requirements.
- Promote Compliance: Encourage applicants to meet regulatory requirements.
- Inform on Progress: Keep applicants updated on the status of their applications.
The Authority strongly encourages input from applicants, particularly feedback on guideline development and implementation, as it fosters dialogue regarding regulatory practices. This feedback enables the Authority to address any procedural or technical shortcomings and improve services.
The Authority engages external experts through telephone, email, and official letters. Expertise in the scientific assessment of the quality, safety, and efficacy of medical products is not limited to applicants and NRAs. When needed, the Authority may identify and outsource experts from various institutions, including academia, consulting companies, health institutions, health programs and departments, pharmaceutical companies, medical associations, and individual experts.
The Authority communicates with the general public about its mission and accomplishments to foster greater public awareness, understanding, and confidence. For TMDA, transparency initiatives typically involve web-based information about its organization, operations, decision-making processes and criteria, and actions such as application approvals and product recalls.
There are also mechanisms for the public to provide input on medical needs, efficacy expectations, and risk tolerances, such as through public meetings and advisory committees. Providing the public with the opportunity to comment enhances the content and feasibility of proposed guidelines and regulations.
The general public may also be consulted on specific applications under assessment by the Authority when public opinion is considered necessary. Various mechanisms can achieve this, such as surveys, focus groups, public meetings, workshops, and appointments to advisory boards.
Conclusion
In summary, the present guidance outlines the importance of critical thinking during the review process and the various communication channels used by the Authority to engage with stakeholders, applicants, external experts, and the general public.
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