Improving Medicines Availability Tops EU Regulators’ 2025 Workplan

The coordination group for EU mutual recognition and decentralized procedures is inviting stakeholder feedback on its priorities for the coming years.

Source: Alamy

Getting Access To Essential Medicines Is An Ongoing Challenge For Smaller EU Markets

Improving the availability of essential medicines in the EU is among the key priorities in the latest workplan of the CMDh - the group that coordinates issues relating to the marketing authorization of human medicines in two or more member states in accordance with mutual recognition and decentralized procedures.

The CMDh’s multi-annual workplan to 2025 – which is out for stakeholder consultation until 4 April – outlines several short- and long-term actions that the group intends to undertake to address priority areas. 

Improving the availability of medicines, especially essential ones, is at the top of group’s priorities. This is needed as several member states, especially the smaller markets, are continuously facing challenges in terms of medicines not being launched and/or ensuring continuous supply of essential medicines, the CMDh notes in the workplan. This is especially true for pediatric formulations, medicines covering narrow indications, low-volume products and medicines for small patient groups.

To address the issue, the workplan states that the CMDh intends to:

• Help companies obtain a marketing authorization in member states where a medicine is needed and not yet authorized in a more efficient way than ordinary repeat-use procedures, through the provision of advice on the use of accelerated procedures and the inclusion of further concerned member states (CMS) in decentralized procedures (DCP) on request. Repeat-use procedure refers to the use of the mutual recognition procedure (MRP) after the completion of a first MRP or DCP for the recognition of a marketing authorization by other member states.

• Investigate/promote initiatives to reduce barriers to national access or distribution, for example, through the promotion of multilingual packaging and via the European Medicines Agency’s ongoing project on electronic product information (ePI). (Also see "EU Pilot Facilitates Multilingual Packaging To Improve Medicines Availability" - Pink Sheet, 31 Jul, 2020.) (Also see "Plans For EU Electronic Product Information Move Up A Gear" - Pink Sheet, 8 Jun, 2021.)

• Ensure that the implementation of new guidance and legislation does not trigger the risk of shortages.

• Explore which regulatory flexibilities allowed during the coronavirus pandemic can be applied in case of shortages of critical (non-COVID-19) medicinal products.

• Facilitate increased EU coordination in the management of drug shortages. Also, the CMDh will closely follow the outcome of the European Commission’s recent study on the root causes of medicines’ shortages and agree on actions, if applicable. (Also see "EFPIA Unimpressed By Proposals For Tackling EU Medicines Shortages" - Pink Sheet, 31 Dec, 2021.)

Other Priorities

The 2025 workplan also outlines several actions to address four other key priorities, namely:

• Optimize procedures to improve efficiency. Initiatives on this front include reviewing the efficacy of existing procedures (eg, adherence to validation checklist) and identifying areas for improvement, strengthening collaboration within the EU medicines’ network and supporting further simplification of renewals under the current legal framework. Also, there are plans to improve existing work-sharing procedures and develop new work-sharing procedures covering bioequivalence studies, similarity assessments, and core product information for generics and antimicrobials.

• Support EU-wide innovative projects, such as use of electronic product information and repurposing of existing medicines. (Also see "EU Drug Repurposing Pilot Kicks Off" - Pink Sheet, 1 Nov, 2021.)

• Prepare for legislative changes such as those expected as part of the wider Pharmaceutical Strategy for Europe. On this front, the CMDh said it would focus on changes to do away with “unnecessary procedures,” such as deleting the need for submitting renewals and reducing the number of risk management plans (RMPs) for generic medicines. (Also see "From Innovation Mindsets To Incentives And COVID-19 Lessons: How EU Pharma Legislation Should Evolve" - Pink Sheet, 27 Jan, 2022.)

• Optimize communication with interested parties and stakeholders to proactively provide efficient, targeted and timely information.

Since 2015, the CMDh has been operating to five-year multi-annual workplans (MAWPs), the first one of which ended in 2020. The group said that until now, it was analyzing the actions in the first MAWP and drawing up priorities and actions for the MAWP to 2025. “Outstanding actions from the previous MAWP have been taken over into the new MAWP to 2025, where appropriate,” it said.

The CMDh’s latest MAWP is complementary to the EU Heads of Medicines’ Agencies (HMA) MAWP and the HMA/EMA European Medicines Regulatory Network strategy 2025, which also focused on ensuring the continued accessibility and availability of medicines. (Also see "EU Stakeholders Want More Focus On Availability Of Medicines" - Pink Sheet, 11 Dec, 2020.)