Euro Roundup: EU committee calls for CMA to reflect burden of green legislation

A European Parliament committee has proposed changing the draft Critical Medicines Act (CMA) to reflect the impact environmental measures have on drug supply.

The Committee on the Environment, Climate and Food Safety submitted the proposals in response to the European Commission’s proposed framework for strengthening the availability and security of supply of critical medicinal products. The proposals are intended to stop overlapping environmental and chemical legislation from causing unintended disruptions.

One draft amendment says that, while the European Union’s environmental policies impose necessary sustainability measures, they may unintentionally burden drugmakers and make manufacturing in the region less competitive.

“Stricter regulations on emissions or on wastewater treatment, or restrictions on key substances, could increase production costs or force companies to relocate outside the Union, exacerbating medicine shortages,” the committee said.

To mitigate the risk, the committee wants the EU to have a balanced and coherent regulatory framework and promote a data-driven approach to enable “policies to be fine-tuned in a manner that preserves the availability of medicines without compromising high environmental and sustainability standards.”

Another amendment warns that environmental and chemical legislation may inadvertently impact the continuity of supply of critical medicines by increasing regulatory burdens or constraining production. The politicians want the EU to counter that risk by assessing the cumulative impact of environmental and chemical legislative frameworks on manufacturing and supply capacities.

Coordination between EU pharmaceutical, environmental and chemical legislation is needed “to prevent negative impacts on patient access to medicines and to ensure the sustainability and competitiveness of the European pharmaceutical and healthcare sectors,” the committee said.

The committee also called for the EU to ensure transparency by making all data related to environmental assessments, authorizations and planning easily accessible through a centralized portal. Procedures must be “efficient, time-bound and must not create undue financial or administrative burdens, aligned with international conventions,” it said.

Draft Opinion

EMA updates guideline on the quality of inhalation and nasal medicinal products

The European Medicines Agency (EMA) has consolidated information on the pharmaceutical quality of inhalation and nasal medicinal products in an updated guideline.

EMA created the guideline to address quality requirements for the drugs in new marketing authorization applications, including abridged submissions. Companies should also consider the general principles set out in the guideline when making changes to authorized medicinal products and during development of medicinal products used in clinical trials, EMA said.

The updated guideline consolidates information from older texts and a related question-and-answer document. EMA also used the update to bring the guideline in line with recent advances in the field, common practice and new regulations, including the Medical Device Regulation (MDR).

Devices for inhaled and nasal delivery must meet the general requirements and the applicable general safety and performance requirements outlined in MDR and an annex to the regulation, EMA said. If a device is co-packaged with the medicinal product, EMA wants to see evidence that the company has met the relevant standards.

The advice on delivery devices only underwent small changes between the draft and final versions of the guideline, but the agency made more significant changes to other sections of the text. EMA added a new section on the uniformity of the dosing of nasal products. The section covers the studies that companies should run to evaluate multidose formulations and single-dose formulations administered with a device.

EMA Guideline

MHRA seeks feedback on the UK drug and device regulatory framework

The Medicines and Healthcare products Regulatory Agency (MHRA) is running a consultation to evaluate whether UK legislation covering drugs and medical devices is working as intended.

Under the Medicines and Medical Devices Act 2021, the UK government must assess the operation and impact of the legislation at least once every five years. MHRA is seeking feedback on UK legislation for medicines, medical devices and clinical trials to support the government review.

“The purpose of this review is to evaluate whether the legislation is operating as intended now, if it continues to effectively protect public health, and avoids imposing unnecessary or excessive regulatory burdens,” MHRA said. “The review is also looking at the structure of the legislation and whether restructure or consolidation would make the regulations clearer or easier to implement.”

MHRA has asked respondents to rank how well the laws protect public health, how well they work in practice, whether they impose unnecessary or excessive regulatory burdens and how they compare with overseas regulations. The agency is also seeking feedback on the clarity of the laws, whether they strike the right balance between flexibility and robust oversight and ways to streamline the regulations.

Officials are accepting feedback until 19 September.

MHRA Consultation

Notified bodies propose approach for conformity assessment of orphan diagnostics

Team-NB has published a position paper on conformity assessments and performance evaluations for orphan in-vitro diagnostics (IVDs).

IVDs used in the diagnosis and management of rare diseases “appear to be overlooked” by the medtech regulations, notified body trade group Team-NB said. The Medical Device Coordination Group published guidance on the clinical evaluation of orphan medical devices in 2024, Team-NB said, but “provisions for orphan IVD devices remain absent.”

Team-NB has moved to fill the guidance gap by communicating its members’ views on how to classify orphan IVDs and assess the tests “to successfully achieve CE marking for providing necessary diagnostic measures for rare clinical conditions.” The paper includes a proposed definition of orphan IVDs.

“An orphan in-vitro diagnostic device, falling under the scope of the Regulation (EU) 2017/746, is intended to provide medical information to benefit patients in the treatment, diagnosis, or prevention of diseases or certain clinical conditions present in not more than 1 in 2000 people (prevalence) in the European Union,” Team-NB said.

The collection and evaluation of performance data for orphan IVDs presents challenges because of the limited patient populations and data availability. Team-NB has proposed managing the challenges using existing tools in the IVD Regulation framework, “such as the option to consult expert panels and obtain certification under defined conditions.”

Position Paper

Other News:

MHRA missed four of its key performance indicators in its 2024 to 2025 financial year. The agency said it fell short of the targets because its strategy for clearing its backlogs “prioritized public health and the expedited assessment of products addressing unmet medical needs and supply shortages.” Eight percent of medicines license applications were processed within 210 days. MHRA Report

EMA updated guidance on the requirements for showing therapeutic equivalence between orally inhaled products for asthma and chronic obstructive pulmonary disease. The revised guideline clarifies that EMA favors a stepwise approach to showing therapeutic equivalence that makes use of in-vitro evidence. The agency has shortened or deleted sections on pharmacodynamic and clinical endpoints. EMA Guideline

The European Pharmacopoeia Commission has adopted three revised quality standards related to pharmaceutical waters. The European Directorate for the Quality of Medicines and HealthCare (EDQM) said the replacement of a test for oxidizable substances with the more sensitive and non-selective total organic carbon test in the “water for injections” monograph is the most notable change. EDQM Notice

MHRA published a decentralized manufacture designation application form on the day new regulations on making drugs at hospitals, ambulances and local care settings in the UK took effect. MHRA Form

Euro Roundup: EU committee calls for CMA to reflect burden of green legislation

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