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The European medicines regulatory system is based on a network of around 50 regulatory authorities from 30 EEA (European Economic Area) countries (27 EU Member States plus Iceland, Liechtenstein and Norway), the European Commission and the EMA (European Medicines Agency). For a medicinal product to be available on the market it needs to have a marketing authorisation. The marketing authorisation application (MAA) must provide evidence of the efficacy, safety and quality of the medicine. When applying for a marketing authorisation for a medicine, the marketing authorisation application is submitted to a regulatory authority, which will assess the medicinal product’s pharmaceutical and chemical quality, efficacy and safety, as well as its risk-benefit ratio.
On April 26, 2023, the European Commission published two legislative proposals1 concerning the regulation of medicinal products in the European Union that revise and replace:
This general reform of pharmaceutical legislation would be the largest reform in over 20 years – to make it more agile, flexible, and adapted to the needs of citizens and businesses across the EU. The intention of the European Commission is to achieve a balance between patient access to affordable medicinal products and the need to stimulate innovation. In particular – and as anticipated – data and market exclusivity available to innovative medicinal products would change.
The aim is to achieve the following main objectives:
Impact to Container Closure Systems used to package Medicinal products
Although the proposed legislation is focused on pharmaceutical manufacturing, specific elements of the proposed Directive2 focus on requirements for primary packaging materials.For container closure components, the following information is required in the submission:
Impact to Devices used in combination with Medical Products
The proposed pharmaceutical legislation is to work complementary with the established Medical Device Regulation EU 2017/745 for products that combine a medical device and medicinal product.
Integral Combination Products are medicinal products where the medical device and/or device part and the medicinal product form an integral product that is not reusable and where the action of the medicinal product is principal3. For an integral combination of a medicinal product with a medical device and for combinations of a medicinal product with a product other than a medical device, the marketing authorisation holder bears the overall responsibility for the whole product in terms of compliance of the medicinal product with the requirements of this Directive and the [revised Regulation(EC) No 726/2004] and the safety and effectiveness of the device.
Co-Packaged combination products are Medicinal products placed on the market by the Marketing Authorisation Holder (MAH), where the medical device is packed together with the medicinal product4. To ensure that the competent authorities have all the information needed for their assessment of combination products the marketing authorisation applicant shall submit data establishing the safe and effective use of the medicinal product taking into account its use with the medical device. The competent authority should assess the benefit-risk balance of the medicinal product, also including results of the assessment of by a Notified Body (E.g. Declaration of Conformity or CE Mark).
Next Steps
The proposal will now be discussed by the parliament and the council with the aim of feeding into the legislative debate. The regulation and directive will have to go through the EU’s legislative process before being approved, it’s unlikely this will be done before the European Parliament elections in 2024, but we cannot predict the timing for adoption at this stage.
How West can help
Please download this detailed West Regulatory Insights paper for additional information.
References:
Have you successfully developed a drug product in a prefilled syringe and are now wondering how to get it on the European market?<br />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.
The combination product market has seen a significant amount of growth,<sup>i</sup> driven primarily by the rise in chronic disease indications, the demands for self-administered therapies and technological advancements. The use of combination products simplifies the process of drug administration for the patient and/or the caregiver and, in some cases, allows the patient to receive treatment at home rather than having to travel to a medical facility. However, there are many challenges that need to be navigated as one considers the transition from a vial system to a needle-based combination product.
One of the increasing trends in the world of drug-device combination products is the use of platforms for drug families, delivery device technologies, and primary packaging.
West’s Mike Schaefers and Heike Kofler recently published a chapter entitled, “Primary Packaging Components Elastomeric Closures for Pharmaceutical Applications” to APV Basics <em>Pharmazeutische Packmittel</em> (Elastomeric Pharmaceutical Packaging).
The recent Pharmapack meeting in Paris provided a great global overview of the latest in pharmaceutical packaging and delivery. This meeting involved not only the traditional tradeshow, but presentations from pharmaceutical and biotechnology companies as well as from companies offering packaging and delivery systems.
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