Euro Roundup: European Commission seeks feedback on planned changes to GMP guidelines

The European Commission has released draft changes to good manufacturing practice (GMP) guidelines for consultation.

Officials framed the planned revision of EudraLex Volume 4 Chapter 1 as necessary to “establish efficient regulatory frameworks based on good science and risk management.” Specifically, the Commission wants to change the text to reflect the International Council for Harmonisation’s revised ICH Q9 guideline on quality risk management. The planned changes include a new principle for GMPs in the EU.

“A proactive approach to quality risk management is of strategic importance in achieving an effective pharmaceutical quality system, in facilitating continual improvement, and in enabling informed and timely decisions throughout the product lifecycle,” the Commission wrote in the draft chapter.

The Commission has proposed the biggest changes to the sections of the guidelines on product quality review and quality risk management. The product quality draft states trending data from the previous review should be included when few batches of a product were made in a 12-month review period. The change is designed to ensure a more extensive dataset is used to assess the consistency of the process.
Proposed changes to the quality risk management section include the recommendation that quality is assured “based on appropriate risk-based decision making throughout the product lifecycle, such that the attributes that are important to the quality of the medicinal product are maintained and the product remains safe and effective.”

The Commission has proposed allowing companies to apply “an appropriate level of formality” to quality risk management activities. The proposal means “lower risk issues may be dealt with via less formal means, freeing up resources for managing higher risk issues and more complex problems that may require increased levels of rigor and effort,” the Commission said.

The draft is open for comment until 3 December.

Commission Consultation

Stockpiling splits politicians in debate over Critical Medicines Act

A call for the Critical Medicines Act to support the mandatory redistribution of stockpiled drugs between European Union countries has divided politicians in a debate about the legislation.

Committee on Public Health rapporteur Tomislav Sokol attended the debate to discuss changes proposed by the European Parliament body. Sokol said the suggested revisions to the stockpiling rules are the biggest change between the European Commission’s proposal and the version drafted by the committee. The draft proposes two major changes, one of which is the creation of an EU coordination mechanism.

“This mechanism introduces a digital reporting system so that Member States provide real-time updates on their stockpiles,” Sokol said at a meeting of the SANT Committee on Public Health. “It also establishes redistribution rules to allow medicines to move from where they are unused to where they are urgently needed, preventing shortages in one country while stockpiles accumulate in the other.”

The redistribution rules would enable the mandatory transfers of drugs from countries with stockpiles to countries where the products are in short supply. Sokol said the EU needs to move beyond the current voluntary mechanism because “it’s still questionable what would happen in case of another major crisis like what happened with the COVID-19.”

Distribution will be based on objective risk assessments and real-time data, Sokol said, and will ensure that contributing Member States retain their minimum reserves and are fairly reimbursed. The mechanism is a “last resort instrument” activated when national and voluntary solutions are exhausted, Sokol said. The measures are designed to prevent the misuse of the mechanism.

Sokol said he knows the plan “will create some obstacles from some Member States, especially bigger ones.” The debate about the proposals provided a preview of some of the arguments that may be raised about the proposal.

Bruno Gautrais, head of the Commission’s unit for medical product quality, safety, and innovation, said “we must consider the practical implications of some provisions,” considering that the proposal covers hundreds or thousands of products “with very different challenges and market situations.”

“We also have to pay attention to the principle of subsidiarity,” Gautrais said. “Specifically, we have to check the feasibility of certain measures, such as the monitoring of stocks and the redistribution of medicinal products.”

Subsidiarity means decisions should be taken at a national level when EU intervention is not necessary. Sokol countered the argument by saying the proposal meets the principle “because we don't go beyond what is necessary to achieve our objective to ensure security of supply.”

Meeting Recording, Press Release

UK tweaks medical device fee amid widespread opposition, sets April 2026 start date

The UK government is pushing ahead with a revised version of a medical device fee that was opposed by most respondents to a consultation in 2024.

Officials sought feedback on plans to change the medical device registration fee to cover the costs of post-market surveillance. Only 10% of the 171 respondents to the consultation agreed with the proposal. The fee was opposed by 72% of the respondents. Critics of the proposal said the fee was too high, would stop companies from selling devices in the UK, and would disproportionately affect certain companies.

In response, the government has proposed charging the fee at a higher Global Medical Device Nomenclature (GMDN) category to ensure “a more equitable spread of the cost between manufacturers of different product types.”

The government will charge manufacturers annually based on how many GMDN level 2 categories they are registered under. Companies with multiple devices in one category will only pay once. Similarly, devices that fall under more than one level 2 category will only be charged once. The new fee will replace the current one-off registration fee.

Officials intend to start charging the fee on 1 April. The government plans to partly subsidize the fee in the first year, resulting in a charge of around £300 ($400). Officials have proposed moving to full cost recovery for the 2027 to 2028 financial year but are yet to share more details.

Government Response

MedTech Europe calls for digital policy framework that aligns with device regulations

MedTech Europe has urged EU policymakers to align pan-industry digital legislation such as the Artificial Intelligence (AI) Act with sector-specific requirements.

The medtech trade group addressed the AI Act, the Cybersecurity Act, the Data Act, and the European Health Data Space in a paper on EU digital legislation. MedTech Europe said it welcomes the European Commission’s “drive towards simplification” but wants to see changes “to avoid duplicative or conflicting obligations that would create unnecessary complexity and regulatory and administrative burden.”

In a position paper, MedTech Europe identified issues with the application of each piece of EU digital legislation to its members and proposed fixes. The current August 2027 application date of the AI Act is one of the issues raised by the trade group. MedTech Europe said the timeline “risks delaying access to safe and effective AI-enabled medical technologies” and requested a two-year extension.

Press Release

Other News:

A “sharp rise” in illegal GLP-1 medicines has triggered a warning from the European Medicines Agency and the Heads of Medicines Agencies. The regulators said unauthorized diabetes and weight-loss drugs are being marketed as GLP-1 receptor agonists, often via fraudulent websites and on social media. The activity includes hundreds of fake Facebook profiles, ads, and e-commerce listings. Press Release

Euro Roundup: European Commission seeks feedback on planned changes to GMP guidelines

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