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Have you successfully developed a drug product in a prefilled syringe and are now wondering how to get it on the European market?
According to the European Union Regulation (EU) 2017/745 (MDR) Article 1(9), a prefilled syringe (PFS) is identified as “a single integral product which is intended exclusively for use in the given combination, and which is not reusable, that single integral product shall be governed by Directive 2001/83/EC or Regulation (EC) No 726/2004, as applicable” (1). According to 2017/745 Article 1(9), you must prove that the device part of your combination product complies with the appropriate General Safety and Performance Requirements (GSPRs) laid out in Annex I of MDR. As you can no longer do a self-assessment, you will need to reach out to one of the currently designated 43 Notified Bodies in Europe (2) to do the conformity assessment for you. The results of the assessment are then captured in the Notified Body Opinion (NBOp) which you are required to include in the submission file to EMA or your national competent authority.
That explains the theory. In practice, taking a closer look at the GSPRs can be quite frustrating, as the GSPRs were designed to describe requirements for a large variety of medical devices, such as wheelchairs, dialysis equipment, medical gloves, and many more. So, on one hand, they need to be broad enough to include every device category, but at the same time, detailed enough to list relevant safety and performance aspects for each. This challenging undertaking resulted in 14 pages of 23 requirements, each with several subparagraphs.
The first step for drug combination product submission is to determine which GSPRs are applicable to your specific and individual product. This task in itself is a challenge because, as mentioned, the GSPRs are written in a way that leaves a lot of room for interpretation.
The European Commission conducted a survey “to support monitoring and analyzing the availability of medical devices on the EU market in the context of the implementation of MDR […] from the perspectives of key stakeholders” (3). It included the feedback from 39 Notified Bodies within a timeframe of 36 months. According to this survey the second main reason for Notified Bodies to refuse a submission file by an applicant was “Application not complete”, at 27% (3). This implies the submission file is not clear or easy to complete.
For example, GSPR Number 10.2 states: “Devices shall be designed, manufactured, and packaged in such a way as to minimise the risk posed by contaminants and residues to patients, taking account of the intended purpose of the device, and to the persons involved in the transport, storage, and use of the devices. Particular attention shall be paid to tissues exposed to those contaminants and residues and to the duration and frequency of exposure.” (1)
Is this applicable to you? If it is, exactly how would you prove to be compliant?
As determining compliance to GSPRs can be a real challenge, many companies have hired experts or external consultants to address this. One circle of industry experts within the Parenteral Drug Association (PDA) (4) met 3 years ago and decided to develop a document to support the industry in this effort. They created Technical Report 73-2: Application of Medical Device Regulations, Annex I Requirements (GSPRs) for Staked Needle Syringes, which is a continuation of the TR 73: Prefilled Syringe User Requirements for Biotechnology Applications. TR 73-2 “provides recommendations on preparing the required documentation of the device part of the PFS to facilitate obtaining a NB opinion. […] Section 5.0 provides GSPR guidance on the syringe components, syringe subassembly ready for filling, and the device part […]. It systematically recommends the amount and depth of information needed for each relevant GSPR to support pharmaceutical companies in assembling the submission file to the NBs. Section 4.0 provides information on documents that provide guidance on completing the NB submission file. […] TR-73-2 also follows the same structure as the submission file.”
It was released on February 6th, 2024, and can be found here: https://techpubportal.pda.org/
Now that you have a better feeling for the information needed for the submission file to Notified Bodies, the next step is to work together with your suppliers to obtain the necessary documents.In order to facilitate the process of obtaining the needed information from your suppliers, West has developed a Technical Documentation Packages for our NovaPure® 1 mL long and NovaPure® 1-3 mL plunger portfolio used in prefilled syringe applications. Just like TR 73-2, this Technical Documentation Package also systematically leads you through the relevant GSPRs and provides supportive information in one comprehensive document of more than 40 pages with the relevant West documents embedded. All information can be used to support the submission file to regulatory agencies or Notified Bodies.
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