Novel manufacturing technologies ‘fit poorly’ into regulatory models, says EMA
The European Medicines Agency (EMA) announced its ‘EMA Regulatory Science to 2025’, wherein the agency proposes its future regulatory science strategy, which it will consult on with stakeholders.
The agency broke down its core goals for the period into five subsections:
- Catalysing the integration of science and technology in medicines development
- Driving collaborative evidence generation – Improving the scientific quality of evaluations
- Advancing patient-centred access to medicines in partnerships with health care systems
- Addressing emerging health threats and availability/therapeutic challenges
- Enabling and leveraging research and innovation in regulatory science
Contained within the first point is the aim to “facilitate the implementation of novel manufacturing technologies”, which would require the recruitment of expertise to improve the assessment process for such technologies, the EMA stated.
In terms of which ‘novel technologies’ the agency was referring to, it cited the growth and development of continuous manufacturing and additive manufacturing.
However, the EMA conceded, “These new technologies fit poorly into the traditional regulatory models, and may require adaptation or changes to good manufacturing practice (GMP) requirements and standards and the development of specific regulatory guidance and monitoring.”
One of the stakeholders consulted was the European Federation of Pharmaceutical Industries and Associations (EFPIA), which publicly released its own feedback to the agency.
In response to the EMA’s stated goals in the area, the EFPIA recommended that stakeholders ‘further collaborate’ to advance novel manufacturing approaches.
Beyond this, the organisation stated, “EU regulators seem hesitant at times to accept alternative approaches to the provision of evidence generated by modelling, simulation and extrapolation during development, as well [as] pre- and post-authorisation.”
The member organisation, which represents 36 national associations and 40 pharma companies, marked the agency’s capability to facilitate the implementation of novel manufacturing technologies as ‘important’ in its feedback, the second highest priority available in the feedback document.
ATMPs
The EMA also narrowed its focus on the manufacture of products down to advanced therapy medicinal products (ATMPs), under which it categorized cell therapies, tissue engineered products and gene therapies.
For such products, it noted that there are challenges associated due to the decentralised nature of manufacture and delivery.
It noted as an example that cell-based therapies face issues being manufactured consistently, a problem even the largest companies are facing, as well as problems of “ethical and social concern” to deliver the therapies efficiently to patient’s bedsides.
Biosimilars
On the subject of biosimilars, the EMA referred to the European Union (EU) as “the world leader in biosimilar regulation and approval.”
The EU has been at the forefront of promoting the use of biosimilars and has seen success in this regard, with the recent example of a number of Humira (adalimumab) biosimilars approved, which saw individual countries able to make significant savings.
The EMA stated that it wanted to see further uptake through the education of health care professionals and patients to understand the science behind biosimilars.
It also noted that it aims to “address regulatory challenges in manufacturing e.g. statistical assessment of critical quality attributes (CQAs) in the comparability exercise and the evolution of multisource biologicals/biosimilars.”
Measuring CQAs is a process by which a biosimilar manufacturer determines whether its product is equivalent to the reference product, in terms of identity, purity, biological activity, and stability of a drug.
The information for reference product is proprietary and therefore requires biosimilar manufacturers to develop their own customized process.
In regard to biosimilars, the EFPIA ranked the subject as ‘less important’ than other areas of the EMA’s five-year plan. Going further, it stated, “EFPIA does not consider that promotion of the availability and uptake of biosimilars in health care systems to be a regulatory science topic.”
