The article describes the approach to be applied when requesting that a regulatory decision be reconsidered.
The Therapeutic Goods Administration (TGA or the Agency), the Australian regulating authority in the sphere of healthcare products, has published a guidance document dedicated to requests for reconsideration of an initial decision made by the authority. The document provides an overview of the applicable regulatory requirements as well as additional clarifications and recommendations to be taken into consideration by medical device manufacturers and other parties involved in order to ensure compliance. At the same time, provisions of the guidance are non-binding in their legal nature and are not intended to introduce new rules or impose new obligations. The authority also reserves the right to make changes to the guidance, should such changes be reasonably necessary to reflect corresponding amendments to the underlying legislation.
In particular, the present guidance is intended to:
- Outline the scope of regulatory decisions that could be subject to review and reconsideration in accordance with the applicable legislation;
- Provide guidance on the way the aforementioned review could be requested by an interested party;
- Describe in detail the reconsideration process.
The authority also mentions that requests for reconsideration could be submitted with no fee payable.
Reviewable Initial Decisions
First of all, the document outlines the scope of regulatory decisions that are, under the applicable legislation, eligible to be reconsidered. In particular, the document provides references to the specific provisions of the relevant legislation and also mentions that there should always be an affected party interested in the regulatory decision being reviewed. According to the guidance, the review procedure could apply to some of the decisions related to:
- Registration and listing of therapeutic goods,
- Manufacturing of therapeutic goods,
- Conformity assessment certificates,
- Inclusion of medical devices in the appropriate register,
- Suspension and cancellation from the register,
- Exempting medical devices from inclusion in the register,
- Public notification and recovery of medical devices;
- Non-compliance with essential principles
At the same time, there are certain regulatory decisions, including those related to the abovementioned matters, that can not be subject to subsequent review and reconsideration. According to the guidance, such decisions include, inter alia, the following ones:
- Refusal of an application (and notice to the applicant of this) because the application has not passed preliminary assessment,
- Notifying an applicant that an application has not been made in accordance with statutory requirements (including that the information necessary to allow the application to be assessed has not been provided),
- Notifying an applicant that an application made by the applicant was “not effective”, for example, because the application fee has not been paid,
- Scientific advice from the TGA about aspects of quality, safety, or efficacy of medicine
- Informing a sponsor that it is proposed to suspend or cancel a kind of device included in the Australian Register of Therapeutic Goods
The document outlines the scope of eligible regulatory decisions for each of the main regulations in the sphere of medical devices and therapeutic goods in general.
In accordance with the applicable legislation, the initial decision should be communicated in writing to a person representing the entirety responsible for the product in question (the interested party). In certain cases, such initial notifications should also be published on the authority’s website.
As further explained by the authority, such a notice should clearly state that the regulatory decision described therein could be subject to review and reconsideration once requested by the affected party. This should include both levels of review—by the Minister and also by the Administrative Appeals Tribunal—to which the affected party may apply if dissatisfied with the initial decision taken.
Preparing a Request for Reconsideration
In order to assist the parties involved, the authority provides detailed instructions on the way the request for reconsideration should be prepared and highlights the key points to be taken into account in this respect. The guidance also outlines the timeframes for such a request to be submitted, which would depend on the way the initial decision was communicated to the interested party. In particular, for regulatory decisions communicated by virtue of a written notice, a general 90-day notice period applies, calculated from the date the appropriate notice was given to a responsible person. In the case of a decision published in an official source, the said 90-day period should be calculated either (i) from the date of publication or (ii) from the date it came up for the first time. The authority additionally emphasizes that the request made after the lapse of the abovementioned period would not be considered for review.
As further explained by the TGA, a request for reconsideration could be submitted via email with the appropriate reference in the subject. When submitting such a request, it is also important to ensure the following is attached:
- A copy of the initial notification letter,
- A dated and signed statement by the person requesting reconsideration that identifies and describes with as much specificity as possible which component(s) of the initial decision should be reconsidered and set out the reasons why reconsideration is requested,
- Any information or documentation in support of the request, clearly labeled to correspond with (any or each of) the reasons why reconsideration is requested,
The applicant should also indicate the email address to be used for further correspondence on the matter.
The authority additionally emphasizes that in the event that the person applying for reconsideration is different from the person to whom the initial regulatory decision is addressed, the appropriate justification should be provided, including the applicant’s interest and his or her connection to the initial recipient. The request should contain detailed and comprehensive information on the matter.
In summary, the present TGA guidance provides a general overview of the applicable regulatory requirements for the review and reconsideration of initial decisions related to therapeutic goods. The document outlines the scope of regulatory decisions eligible for reconsideration and explains how the appropriate request should be prepared.
How Can RegDesk Help?
RegDesk is a holistic Regulatory Information Management System that provides medical device and pharma companies with regulatory intelligence for over 120 markets worldwide. It can help you prepare and publish global applications, manage standards, run change assessments, and obtain real-time alerts on regulatory changes through a centralized platform. Our clients also have access to our network of over 4000 compliance experts worldwide to obtain verification on critical questions. Global expansion has never been this simple.