RPS R2 Iteration 2 - Multi-Product Submissions

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Regulated Product Submissions | Multi-Product Submissions

Section 1: Multi-product Submissions

The first submission unit of a new application for multiple products Medical device company A submits a new PMA or IDE to a system of products (product family). The products are intended to be used together, but are packaged and shipped separately. The submission unit requests approval for 4 products – a pacemaker, 2 pacing leads, and software to program the pacemaker. The submission unit requests approval for 20 models of a non-active implantable products along with a delivery system that has 5 models

Creation of a new submission within an existing application for multiple products. Medical device company A submits a PMA Supplement against an existing PMA to gain approval for a new family of pacemakers. The new pacemaker family includes 23 products, each with varying hardware and software configurations.

For multiple dosage forms, we simply replicate the 3.2.P sections in the eCTD as outlined in ICH eCTD Specification V 3.2:

<m3-2-p-drug-product product-name="wonder drug" dosageform="tablet-5mg"> <m3-2-p-drug-product product-name="wonder drug" dosageform="tablet-10mg"> <m-3-2-p-drug-product product-name="wonder drug" dosageform= "tablet-50mg">

Dosage forms can added or removed through IND amendments or BLA supplements and approval of the dosageforms is reflected in the approved SPL label (content of label and drug listing).

Sponsor Removal of a product from a submission under review In response to agency question about a mechanical design characteristic of 3 products contained in the submission, the sponsor amends the submission under review to remove the 3 products from the submission. This amendment also withdraws all documentation related to only those 3 models. The review of the submission will continue with the remaining 20 products.

Manufacturing Change that affects multiple submissions Medical device company A changes a significant manufacturing step (or does a plant move) that affects three product families (covered in 3 different PMAs). Three PMA supplements are required, but only one review is necessary (FDA allows a bundled submission, and provides separate PMA supplement numbers).

In Germany we will assign one authorisation number to a product per strength and pharmaceutical form. It may be independently or related in a way if it is a so called Global Marketing Authorisation. This means several strengths or pharmaceuitcals forms will be brought under one umbrella, e.g. 12345.00.00 (50 mg tablets as a basis), 12345.01.00 (50 mg suppositories), 12345.00.01 (100 mg tablets), 12345.00.02 (150 mg tablets). The alternate way is 12345.00.00 (50 mg tablets as a basis), 12346.00.00 (50 mg suppositories), 12347.00.00 (100 mg tablets), 12348.00.00 (150 mg tablets) giving examples for an independent numbering.

For manufacturing changes to a multi-product facility, we submit an eCTD supplement to every application, with the exactly the same content but with different product & substance names. As an example, we could submit a COMPARABILITY PROTOCOL for MULTI-USE DRUG SUBSTANCE FACILITY supplement to the 11 applications. In section 1.4.1 (Cross Reference to Other Applications) of the eCTD, we list the other 10 application numbers, product and substance names. We will then get a single approval letter from the Office of Biotechnology Products referencing all applications and substance names.