A Comprehensive Guide to European Pharmaceutical Legislation: Key Regulations and Updates
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:
- the existing general pharmaceutical legislation (Regulation 726/2004 and Directive 2001/83/EC)
- the legislation on medicines for Children (Regulation 1901/2006 – the Paediatric Regulation)
- and for rare diseases (Regulation 141/2000/EC – the Orphan Regulation)
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:
- Drastically reduce the administrative burden by speeding up procedures significantly reducing authorization times for medicines, so they reach patients faster;
- Create a Single Market for medicines ensuring that all patients across the EU have timely and equitable access to safe, effective, and affordable medicines;
- Continue to offer an attractive and innovation-friendly framework for the research, development, and production of medicines in Europe;
- Enhance availability and ensure medicines can always be supplied to patients, regardless of where they live in the EU;
- Address antimicrobial resistance (AMR) and the presence of pharmaceuticals in the environment through a One Health approach;
- Make medicines more environmentally sustainable.
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:
- A detailed description of the container closure system.
- Rationale on the suitability of the container and closure system used for the storage, shipping and use of the finished product as well as details on the compatibility between medicinal product and container.
- Data to support that the container closure system is appropriate for the intended use specified in the marketing authorization application dossier. Methodology including standards, compendia should be referenced. Non-pharmacopeial methods should be validated.
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).
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.
- European Medicines Association Marketing Authorisation Overview - https://www.ema.europa.eu/en/human-regulatory/marketing-authorisation and Authorisation procedures - The centralised procedure https://health.ec.europa.eu/medicinal-products/legal-framework-governing-medicinal-products-human-use-eu_en
- Reform of the EU pharmaceutical legislation, https://health.ec.europa.eu/medicinal-products/pharmaceutical-strategy-europe/reform-eu-pharmaceutical-legislation_en and FAQs https://ec.europa.eu/commission/presscorner/detail/en/qanda_23_1844
- Proposal for a DIRECTIVE OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on the Union code relating to medicinal products for human use, and repealing Directive 2001/83/EC and Directive 2009/35/EC
- Guideline on quality documentation for medicinal products when used with a medical device, European Medicines Agency, 22 July 2021