Companion Diagnostics (CDx) Consultation & Procedural Aspect Advice
In vitro diagnostic tools called Companion Diagnostics (CDx) are used in conjunction with treatment medications to assess how well they will work for the patients. The manufacturer must send technical and other pertinent documentation to the Notified Body (NB) for technical and conformity assessment in order to market the CDx in the European Union. After the assessment is complete, the Notified Body (NB) would provide the compliance certificate.
The sort of gadget being introduced to the market will determine the conformity evaluation and paperwork required.
• Co-developed CDx: A supplementary diagnostic tool is created along with the therapeutic medication.
• Follow-on CDx: A complementary diagnostic tool is created with the same purpose and similarly targeted biomarker as the initial CDx.
To ensure that all requirements have been met, the Notified Body (NB) conformity assessment is performed. The conformity assessment of companion diagnostics is covered in Section 5.2 of Annex IX of EU IVDR 2017/746, and producers must provide information on:
• Information provided with the device (labels, Instructions for Use (IFU), etc.); device description and specification (including variants and accessories);
Information on general safety and performance, design and manufacturing, risk analysis and risk management, and general safety and performance
As part of the compliance assessment, the Notified Body (NB) may look for a scientific opinion on the drug. In accordance with Directive 2001/83/EC, the Notified Body (NB) must consult the European Medicine Agency (EMA) or the relevant regulatory bodies for pharmaceutical products. The medicinal product must fall under the mandatory scope, and the centralized procedure must be followed (one evaluation is carried out, and the product is approved throughout the European Union) for the Notified Body (NB) to consult EMA. Alternatively, the medicinal product may already be authorized or be undergoing review for authorization under the centralized procedure.
The EMA has provided detailed instructions on the companion diagnostics consultation process, and the process is broken down into many phases:
• Phase Before Submission
• Presentation Stage
• Evaluation Phase
• Phase following consultation
Phase Before Submission
Three (03) months before to the deadline for submitting the request for the scientific opinion, the Notified Body (NB) is needed to send the “intent-to-submit” letter to the EMA. The Committee for Medicinal Products for Human Use (CHMP) will designate a rapporteur, and in the case of advanced therapies, the Committee for Advanced Therapies (CAT) will appoint a second rapporteur in addition to the CHMP rapporteur. It is advised that any queries regarding the consultation process be sent within two (02) months of the anticipated submission date.
Presentation Stage
The application must be submitted to the CHMP/CAT by the Notified Body (NB), along with any other pertinent paperwork. An application form, a cover letter, a draught of the Instruction For Use (IFU), and a draught of Summary of Safety and Performance should be included (SSP). The CHMP/evaluation CATs of the consultation are based on the suitability of the included pharmaceutical product(s) and the companion diagnostic. The clinical advantages and patient safety, as well as the product’s clinical and analytical performance, can all be taken into account when determining appropriateness. As a result of the Notified Body’s (NB) prior examination of the design dossier document, the consultation focuses solely on the companion diagnostic’s compatibility with the relevant medical product(s).
Evaluation Phase
Within sixty (60) days following the start of the consultation process, the EMA will offer its scientific opinion. If there are any additional debts, this time frame may be extended. The Notified Bodies (NBs) are given a list of questions in case the CHMP/CAT has any concerns or requests clarification; these questions must be answered within the allotted time period. The CHMP develops and publishes the scientific opinion following the assessment. When it comes to advanced medicines, the CHMP bases its scientific opinion on the CAT’s draught opinion. The Notified Body has then forwarded this document (NB). Based on this judgment, the Notified Body (NB) will go on to inform the EMA of its final decision.
Phase following consultation
A follow-up session is set up in the event that changes are made to the device that affects its performance or intended use. Examining these adjustments, the Notified Body (NB) consults with the EMA. A new initial consultation will be held if the Notified Body (NB) views it as a new conformity assessment.
One of the crucial factors in approving companion diagnostics and subsequently launching the product on the EU market is consultation. The process of consultation between the Notified Bodies (NBs) and the appropriate authorities or the EMA must be properly understood by the makers of companion diagnostics. When preparing the overall project, the manufacturers must take into account the consultation dates and organize the submission materials accordingly.
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