Euro Roundup: European medicines network joins WHO listed authority program

The World Health Organization (WHO) has recognized the European Medicines Regulatory Network (EMRN) under its WHO Listed Authority (WLA) framework. EMRN’s designation positions it as a reference point for other regulatory authorities.

WHO launched the listed authorities framework in 2022 and has created a list of WLAs that “can be relied on for fulfilling the highest level of regulatory standards and practices for quality, safety and efficacy of medicines and vaccines,” according to WHO.

“This acknowledgement provides a formal basis for the important work that [European Medicines Agency (EMA)] and the EU are already doing to promote reliance practices globally,” EMA Executive Director Emer Cooke said in a statement. “We will continue our commitment to ensuring that available medicines are safe, effective, and of high quality and look forward to our work with WHO and other regulatory authorities around the world to improve global public health.”

EMRN is comprised of EMA, the European Commission and the regulatory authorities of 30 European countries

EMRN’s designation covers all regulatory functions for the product streams of medicines and vaccines. The designated medicines functions cover generics, new chemical entities, biotherapeutics and similar biotherapeutic products. WHO approved the US Food and Drug Administration (FDA) in the same functions and expanded Singapore’s approval to include market surveillance and control.

The addition of EMRN and FDA to the WHO initiative means the framework now includes 36 regulatory authorities from 34 countries. WHO said there “are a few stringent regulatory authorities pending evaluations following their expressions of interest” in being assessed as a WLA.

Pharma trade group EFPIA welcomed the expansion of the framework, calling it “another crucial step in enhancing international cooperation to promote access and supply of safe, effective and quality medical products.”

EMA Notice, WHO Statement, EFPIA Notice

MHRA creates antimicrobial resistance team to support drug developers

The UK Medicines and Healthcare products Regulatory Agency (MHRA) is creating a dedicated team to provide regulatory scientific support for organizations creating novel antimicrobials and diagnostics.

MHRA envisages the new team developing an in-depth knowledge of new technologies and building an antimicrobial resistance (AMR) community with global regulators. The agency particularly wants to work with regulators in low- and middle-income countries. The U.K. government’s Global AMR Innovation Fund (GAMRIF) is providing £1.8 million ($2.3 million) to support the work.

June Raine, chief executive of MHRA, said the plan is to create “a one-stop shop of regulatory scientific activities that supports GAMRIF-funded projects and programs globally.” The support will apply wherever the developers of the novel products seek regulatory approval.

“This wraparound regulatory support will maximize the likelihood that innovative products developed within GAMRIF-funded portfolios of context-specific, accessible, and affordable novel products secure regulatory approval in low- and middle-income countries,” Raine said in a statement.

The innovations supported by the team will facilitate advances in diagnostics and enable the agency to “expand the scope of its knowledge to keep pace with scientific advances,” according to MHRA. The team will share early-stage advice through MHRA’s existing Innovation Accelerator, establish the scientific framework for assuring the quality of AMR-tackling products and advise on the preparation of calibrants.

UK officials disclosed the MHRA initiative alongside a broader package of AMR programs that will receive £85 million. The funding pledge includes £50 million to help countries and institutions in Africa access essential antimicrobial drugs.

Press Release, More

EMA moves to suspend women’s health drug over lack of efficacy, cancer reports

EMA has moved to suspend marketing authorization for hydroxyprogesterone caproate in the EU after assessing an unconfirmed risk of cancer and the lack of compelling efficacy data on the products.

Some EU countries use hydroxyprogesterone injections to prevent pregnancy loss or premature birth. The drug is also authorized for other gynecological and fertility disorders, including conditions caused by a lack of progesterone. However, EMA’s Pharmacovigilance Risk Assessment Committee is unconvinced of the drug’s efficacy.

The committee reviewed studies that showed the drug is ineffective at preventing premature birth. One study of more than 1,700 pregnant women with a history of preterm delivery found the drug was no more effective than placebo. In other indications, EMA found limited data on the drug’s efficacy.

EMA weighed those uncertain benefits against a potential cancer risk. A large population-based study found people who were exposed to the molecule in the womb may have an increased risk of cancer, although there was a low number of cases and that the study had some limitations. The committee said a cancer risk is possible but unconfirmed. Alternative treatment options are available.

EMA Notice

EDQM shares draft guidance on content of the dossier for sterile substances

The European Directorate for the Quality of Medicines & HealthCare (EDQM) is seeking feedback on draft guidance on the content of the dossier for sterile substances.

EDQM created the draft to serve as a guide for compiling a dossier to obtain Certificate of Suitability (CEP) for a sterile substance. CEPs, which certify an ingredient complies with a monograph, can apply to sterile substances but applicants need to provide additional information. EDQM updated its policy last year and has now followed up with draft guidance.

The document walks through the information applicants should include in submissions, starting with a justification for the method of sterilization. Manufacturers typically use sterile filtration. If dry heat sterilization is used, applicants need to “adequately” justify their approach, EDQM said.

Across the other sections, EDQM discusses the requirements for manufacturing areas, the validation and sterilization of filters, aseptic processing and other activities companies need to discuss in their dossiers.

EDQM is accepting feedback on the draft until 15 August.

EDQM Notice

Commission looks back on progress of EU health network, outlines next steps

The European Commission has published a report that covers the progress of the European Health Union over the past five years and the areas where there is still work to do.

With the 2019 to 2024 EU mandate coming to an end, the Commission looks back in the report at a time defined by the pandemic. The report highlights the reform of the pharmaceutical legislation as an area where the EU made progress. Officials also outlined the next steps in their attempts to improve the Medical Device Regulation.

“The Commission will launch, later this year, a targeted evaluation of the EU medical device legislation including a structural assessment of the impact on the availability of medical devices and on the innovation and competitiveness of the medical device system in the EU, as a first step towards identifying sustainable solutions for the future,” the Commission said.

Overall, the Commission concluded that the EU is “in a much stronger position” in terms of health than five years ago but there is still a lot of work to do. However, the EU has redeployed some of the health budget to help Ukraine and there is uncertainty about future funding.

Press Release

Euro Roundup: European medicines network joins WHO listed authority program

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