Le Conseil International des Excipients Pharmaceutiques - Europe
IPEC Europe
1.
ID: 341962119314-36
Lobbying Activity
Response to Revision of the definition of engineered nanomaterial in food
12 Jan 2024
IPEC Europe welcomes the opportunity to comments on this draft delegated regulation. The definition of a Food as an engineered nanomaterials means that the word (nano) must appear on the ingredients list next to that material; this is intended to provide information for the consumer (Regulation (EU) 1169/2011). However, since this was first proposed we have seen a proliferation of negative, often unscientific, articles/posts published about the dangers of nanoparticles, without any risk assessment being conducted. This means that the labelling of (nano) is now likely to be perceived as a warning. This is at odds with the work of EFSA who are responsible for that risk assessment and there is a danger that this will bypass that risk assessment process. For example, in its current format this legislation will require the labelling of the food additives iron oxides as engineered nanomaterials which in effect constitutes a warning. However, these materials are also undergoing an EFSA safety review which is due to be published in 2024; there seems to be a disconnect between the principles of this labelling and the EFSA safety review process. Full comments in the enclosed document
Read full responseResponse to Evaluation and revision of the general pharmaceutical legislation
27 Apr 2021
IPEC Europe fully supports the proposed revision of the general pharmaceutical legislation and is pleased to be able to offer feedback as it pertains to pharmaceutical excipients.
IPEC Europe represents the producers, the distributors of pharmaceuticals excipients as well as the pharmaceutical companies using excipients. The pharmaceutical excipients are the substances other than the API which have been appropriately evaluated for safety and are intentionally included in a drug delivery system.
Excipients can represent up to 95% of a final medicinal product. While they can act as fillers and diluents, they can also enhance solubility, stability and control the rates of drug release and bioavailability. As excipients play a significant role in delivering safe and effective medicines, we believe this roadmap should specifically address the regulatory pathways essential to fully maximise the use of (novel) excipients.
A novel excipient is one used for the first time in a medicine, at an unprecedented use level or new route of administration. Their use can foster innovation and help to formulate both novel and existing drugs improving their efficacy, quality and safety.
There is no regulatory pathway for the independent review of novel excipients in Europe, which is a strong hindrance to innovation in the development of medicines.
Innovative companies may choose not to use novel excipients to formulate APIs: novel excipients are only approved together with the API for a specific medicine. This requires multiple submissions of large data sets of confidential information and repeated assessments by regulators which is inefficient and prolongs approvals.
Advanced treatments and therapeutics, particularly in biologics, for example m-RNA vaccines, increase the need to use novel excipients. Equally, the use of novel excipients can extend the usefulness of existing APIs to develop medicines to treat various therapeutics conditions.
The lack of a workable system for novel excipients in the EU has a negative impact on Europe’s innovative medicines development compared with other countries (China, USA) to the detriment of EU patients.
An independent regulatory pathway protecting the confidential manufacturing know-how of novel excipients would encourage collaboration between their discoverers and SMEs to develop innovative medicines.
We would propose:
• A modular approach: the Master File System for APIs (ASMF) should be extended to novel excipients providing an independent review. Data needs for novel excipients are the same as for APIs and regulatory equality is essential.
• Cross-referencing a novel excipient Master File in a MAA would ensure a full review by EMA shortening approval times and simplifying authorisation procedures.
• Novel excipient manufacturers could work in parallel with developers of medicines and reduce approval times, especially in crisis situations.
• The confidential manufacturing know-how of the novel excipient will be protected.
These initiatives should be included in the ‘Combined evaluation roadmap/inception impact assessment’ that the DG SANTE is working on.
Barriers to innovation would be reduced making Europe more competitive, agile and, on a level playing field with other global markets (such as China and USA).
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