EU Critical Medicines Alliance, EMA Concept paper on Biosimilar development, new African Medicines Agency (AMA), French early access programs

EU Critical Medicines Alliance

As part of its 2024 Work Plan, the European Health Emergency Preparedness and Response Authority (HERA) launched, on Tuesday 16th of January 2024, an open call for expression of interest to join the Critical Medicines Alliance. The set up of this Alliance is one of the key actions to prevent and address shortages of critical medicines announced by the Commission in October 2023.

The Critical Medicines Alliance is a consultative mechanism which brings together all relevant stakeholders, to identify the challenges, priorities for action and propose solutions to strengthen the supply of critical medicines in the EU, to better prevent and combat their shortages.

The work of the Alliance focuses on a targeted number of critical medicines with the highest risk of shortages and impact on healthcare systems.

For support on methodology for screening of portfolio regarding criticality

EMA Concept paper on a tailored clinical approach in Biosimilar development

On 1st February 2024, the EMA has released a concept paper for the development of a reflection paper on a tailored clinical approach in biosimilar development.

Currently, the required comparability exercise comprised quality data (analytical comparability exercise), in vitro and in vivo non-clinical data, and comparative pharmacokinetic, pharmacodynamic, safety and efficacy studies. However, considering the advances in the analytical sciences and the extensive regulatory experience gained, in vivo non-clinical data and, at least for some less complex biologicals with a straightforward mechanism of action, the importance of dedicated clinical efficacy and safety data should be re-evaluated. Currently, the need for Comparative Efficacy Studies (CES) is increasingly questioned in general.

For support on MAA strategy

How will EMA support the new African Medicines Agency (AMA)?

AMA will be a specialised agency of the?African Union (AU)?dedicated to improving?equitable access to quality, safe and?effective medical products?in Africa. To date, 27 countries have ratified the AMA treaty, and more AU members are expected to complete the process in the coming months. The creation of AMA is a unique opportunity to facilitate the regulation and oversight of key medicines at continental level, promoting collaboration among African countries and regions.

By sharing its unique expertise and regulatory model, the European medicines regulatory networkwill (EMRN) will share experience with AMA in pooling resources and coordinating work to regulate medicines efficiently and effectively, ensuring high-quality standards and use of the best available expertise, reducing administrative burden to allow medicines to reach patients faster and accelerating the exchange of information on critical issues such as medicines safety.

For more information

What are the mechanisms for early and compassionate access in France?

Atessia supports its clients daily in the practical modalities of implementing the French early and compassionate access system, whose subtleties require some explanations.?

Since July 1st, 2021, early access targets medicinal products that meet an unmet therapeutic need and may be innovative. The laboratory submits a request for early access authorization (AAP) to the High Authority for Health (HAS) and, for medicinal products not yet authorized under a Marketing Authorization (AMM), to the National Agency for the Safety of Medicines and Health Products (ANSM).??

This mecanism applies to:?

• A medicinal product prior to obtaining the AMM in the considered indication (Pre-AMM AAP = AP1),?
• A medicinal product that already has an AMM in the considered indication, prior to common law coverage by health insurance (Post-AMM AAP = AP2) Interestingly, the product may or may not have an AMM for another indication. As per HAS doctrine, granting early access authorization is reserved for certain specialties meeting the following 5 cumulative eligibility criteria:?

1. Strongly presumed efficacy and safety in the considered indication.?

2. The disease to be treated is severe, rare, or disabling.?

3. There is no “appropriate treatment.”?

4. The implementation of treatment cannot be delayed.?

5. The medicinal product is presumed to be innovative.

Support on FR early access program.

Our Team is Here for You

Atessia accompanies you on French early access programs for medicinal products: hello@atessia.fr

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