Euro Roundup: EMA survey shows SMEs want simplification, streamlining to ease regulatory burdens

Small and medium-sized enterprises (SMEs) have asked the European Medicines Agency (EMA) to simplify and streamline regulations to ease some of the burdens on their operations.

EMA collected the views of SMEs in an online survey that garnered 266 unique and valid responses. The survey showed “strong satisfaction with EMA’s support, especially regulatory assistance services, fee incentives, the SME qualification process and training,” the agency said. Respondents praised tools such as the SME User Guide, but awareness of some services was limited.

The survey also uncovered problems as respondents “highlighted challenges such as the regulatory burden, access to finance and regulatory fees, calling for regulatory simplification and streamlining, access to funding and enhanced advice and support,” EMA noted.

One-fifth of the respondents cited administrative and regulatory burden as a challenge. Specifically, SMEs told the agency that they face challenges related to the medtech and clinical trial regulations, the lack of harmonization of requirements across authorities, and evolving demands driven by innovative products such as targeted therapies and companion diagnostics.

In response, SMEs suggested that EMA simplify and streamline regulatory frameworks for the development and approval of medicines and technologies, introduce flexibilities and exemptions for regulatory procedures or requirements, and enhance regulatory and scientific advice throughout the product lifecycle. Other suggestions include providing support for decentralized procedures.

Almost 60% of respondents said EMA should expand regulatory assistance services. The survey also found that SMEs want the agency to cut the timelines of regulatory processes and procedures and strengthen its support after a product is authorized.

Access to finance (19%) and regulatory fees (13%) were the next most common SME challenges. Respondents proposed easing regulatory fees for SMEs through pre- and post-authorization EMA and national fee incentives, payment deferrals and installments, and changes to activities such as serialization. They also proposed enhanced guidance on SME incentives.

The survey also asked about medicine shortages. Eighty-four percent of respondents had not experienced a medicine shortage in the past two years. Around 50% of SMEs had little to no awareness of shortage reporting obligations and processes. SMEs named lengthy regulatory procedures and approvals, such as authorizations and inspections, as a drug shortage challenge.

Respondents suggested EMA simplify regulatory frameworks and align reporting requirements across the EU, help SMEs prepare shortage prevention and mitigation plans, and introduce fee incentives to support regulatory procedures to prevent and manage medicines shortages.

EMA Report

EFPIA warns of Critical Medicines Act overreach as EU advances stockpile strategy

EFPIA has warned that misclassifying products as vulnerable under the Critical Medicines Act (CMA) “could lead to regulatory overreach and trigger disproportionate obligations or procurement distortions.” The trade group issued the warning shortly before the EU launched its stockpiling strategy.

Responding to a European Commission call for feedback, EFPIA assessed the impact of linking the CMA to the vulnerability evaluation set out in the General Pharmaceutical Legislation. The linkage is part of plans to identify medicines at risk of supply disruption, particularly those that rely on a single country, a limited number of manufacturers, or highly concentrated supply chains.

EFPIA supports proactive risk assessment, but is concerned that the current criteria for assessing supply vulnerability rely too heavily on broad indicators like geographic sourcing or supplier concentration. The trade group said the criteria fail to capture product-specific factors such as manufacturing complexity, reliance on rare inputs, shelf life, or actual shortage history.

“This is especially problematic for biologics, vaccines, and advanced therapies, where diversification is often not feasible. Under the current approach, such products could be misclassified as vulnerable, despite having stable, secure supply chains, simply because they rely on specialized production,” EFPIA said.

The Commission published EFPIA’s feedback days before launching strategies for stockpiling and medical countermeasures. The strategies are intended to ensure the continued supply of essential goods, such as food, water, and life-saving medical supplies. Through the stockpiling strategy, the Commission will promote centralized or joint procurement mechanisms and coordinate with member states on supply.

Actions planned under the medical countermeasures strategy include the creation of a list of priority threats, launch hubs to support drug and diagnostic development, and support the detection of threats by easily deployable, ready-to-use laboratories for biological and chemical hazards in emergencies. Many of the actions are scheduled for 2026.

EFPIA Feedback, Press Release

EMA recommends actions to fix anti-D immunoglobulin supply chain vulnerabilities

EMA has recommended steps to secure the supply of anti-D immunoglobulins that are used to prevent immune reactions that can seriously impact the health of fetuses.

Physicians use anti-D immunoglobulins to prevent reactions, which can have fatal outcomes, when a pregnant person with RhD-negative blood type is exposed to RhD-positive blood from their fetus. Plasma collected from donors is the only source used to make medicines. Donor numbers are falling, EMA said, and all the sites that make the medicines are located outside the EU.

EMA is advising Member States to create plans to secure the supply of anti-D immunoglobulins in the EU, work to reduce unnecessary use of the products, and support the development of alternatives. The agency wants manufacturers to ensure an adequate supply of immunoglobulins in the EU by investing in optimizing manufacturing capacity and developing alternatives to plasma-derived immunoglobulins.

Regulatory officials also encourage the Commission “to identify measures to ensure supply continuity of these medicines and support and coordinate Member States’ activities.” EMA said, “Policy measures set out in the proposed Critical Medicines Act could be leveraged, such as joint procurement of manufacturing services to establish or increase the supply of these medicines to the EU.”

Press Release

MedTech Europe voices opposition to EU proposals for packaging waste sorting labels

MedTech Europe has joined other organizations to express “strong concern and opposition to using text and color for waste sorting labels on packaging.”

Draft EU guidelines prioritize using full-color labels with accompanying text to inform waste sorting. MedTech Europe and other signatories of the statement said the proposal would reintroduce national barriers to the movement of packaged goods, despite the Commission identifying divergent packaging labels as one of the most disruptive barriers to the internal market.

The draft guidelines include design options for a pictogram-based system. However, the trade groups said the draft restricts “the use of color- and text-free alternatives to cases justified by economic constraints, specific consumer readability needs, or to very small packaging.” MedTech Europe is urging the Commission to reconsider the direction of the guidelines.

Joint Statement

Other news

The Commission has changed an implementing decision about medtech expert panels. The changes reflect experience working under the original decision, which showed a need to adapt aspects “such as the timing of the publication of scientific opinions and the remuneration of experts for the development and review of guidance, common specifications and standards.” Implementing Decision

The UK Medicines and Healthcare products Regulatory Agency (MHRA) published a standardized form for periodic safety update reports. MHRA created the document to advise manufacturers on what data to include in reports. Manufacturers can display data in an alternative form, if appropriate, and do not need to complete sections that are not relevant. MHRA Notice

Euro Roundup: EMA survey shows SMEs want simplification, streamlining to ease regulatory burdens

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