The new article addresses the matters related to the applicable review timelines, fees payable, and changes to registered combination products.
The Medical Device Authority (MDA), a Malaysian regulatory agency in the sphere of medical devices, has published a guidance document dedicated to the drug-medical device and medical device-drug combination products. The document is intended to provide additional clarifications regarding the applicable regulatory requirements, as well as recommendations to be followed by medical device manufacturers in order to ensure compliance thereto. At the same time, provisions of the guidance are non-binding in their legal nature, nor are intended to introduce new rules or impose new obligations. Moreover, the authority reserves the right to make changes to the guidance and recommendations provided therein, should such changes be reasonably necessary to reflect corresponding amendments to the underlying regulations.
The document describes the approach to be applied with submitting an application for marketing approval for combination products and pays special attention to the aspects related to the regulatory authorities involved since due to the nature of combination products, both medicines, and medical devices regulatory agencies are participating in the review process, hereinafter referred to as the “Primary Agency” and “Secondary Agency” determined based on the principal mode of action of the product in question (i.e. where the therapeutic result is achieved mostly due to the drug or medical device part).
The scope of the guidance covers, inter alia, the applicable registration timelines for combination products. In particular, the document provides a timetable indicating the working days necessary to complete each of the steps of the application process. The authority also mentions that due to the two regulatory agencies involved in the process, the actual timeframes could differ from the ones described in the guidance.
As it was mentioned before, the entire review process is comprised of two consequent steps (stages). For drug-medical device combination products, the applicable timelines will be as follows:
- Stage 1 (review by MDA): 90 business days in case of approval from reference countries available, and 180 business days in case there are no approvals by reference countries.
- Stage 2 (review by NPRA, the medicines regulatory agency): from 210 to 245 business days depending on the type of medicinal product in question.
For the purpose of the guidance, an approval from the reference country stands for marketing approval granted by a respective trusted national regulating authority in another country for the same product. In accordance with the applicable regulatory requirements, when applying for marketing approval, medical device manufacturers may refer to marketing approvals granted in other jurisdictions when demonstrating compliance with the applicable regulatory requirements in terms of safety and effectiveness. Such an approach is intended to facilitate the review process and reduce the regulatory burden, also ensuring the more efficient allocation of the authority’s resources.
For medical device-drug combination products, the applicable review timelines will be as follows:
- Stage 1 (evaluation by NPRA): 180 business days;
- Stage 2 (evaluation by MDA): from 30 to 60 business days depending on the class of the device under the applicable risk-based classification, where 30 days will be in the case of Class A (low-risk) medical devices, and 60 days for all other classes.
The document also provides information about the fees payable by the interested parties for the registration of combination products. As it is stated by the authority, an application for marketing approval should be accompanied by a fee payable with respect to the review to be conducted by each of the agencies. The authority additionally emphasizes that such a fee is non-refundable, while the failure to pay the fee as required would result in the application being left without review.
The fees payable to NPRA would depend on the type of medicinal product subject to review, and also on the number of active ingredients. At the same time, the authority will not charge fees for the endorsement of a medical device-drug combination product.
The fees payable to MDA would depend on the availability of approval from reference countries.
Another important aspect described in the guidance relates to post-approval changes/variations to particulars of a registered combination product. The document describes separately the procedures to be applied with respect to each drug-medical device and medical device-drug combination products.
According to the guidance, application for changes to particulars of ancillary medical device component for a registered drug-medical device combination product shall be submitted to MDA manually…MDA shall issue an approval letter upon satisfactory evaluation, and this approval letter shall then be sent to NPRA for notification. In this respect, the authority emphasizes the following matters to be considered:
- In the case of low-risk ancillary medical device components, an application for changes is not mandatory;
- In case an ancillary medical device the product contains has already been approved by MDA, and the appropriate change notification has also been approved, a separate change notification for the said device as a component to a combination product is not required.
As further explained in the document, an application for changes to particulars of medical device component for a registered medical device-drug combination product shall be required to comply with the Guidance document of Change Notification to Registered Medical Device, while an application for changes to particulars of ancillary drug component…shall be submitted to NPRA manually. Upon successful completion of its review, NPRA will issue an approval letter and forward it to MDA.
In summary, the present MDA guidance describes in detail certain specific aspects related to medical device-drug and drug-device combination products. In particular, the document provides information about the fees and review timelines, and also explains the approach to be applied in case of changes to combination products and components thereof after the initial marketing approval has been granted.
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