EMA Prepared for Health Technology Assessment Regulation Implementation

The European Medicines Agency (EMA) announced on Jan. 10, 2025 that it is prepared for the implementation of the health technology assessment regulation (HTAR) that comes into effect on Jan. 12, 2025 (Regulation (EU) 2021/228) (1, 2). The HTAR accelerates and widens access to new medicines in the European Union and creates a framework for the assessment of certain high-risk medical devices. The allows for cooperation between regulators in the evaluation of the risks and benefits of medicines, expanding the cooperation between EMA and health technology assessment (HTA) bodies.

New regulations will start with new active substances for oncology products and advanced therapy medicinal products (ATMPs). Rules will then be expanded to orphan drug products in January 2028 and then all centrally authorized products in 2030.

The agency has been working with the European Commission (EC), EU Member States, and stakeholders from industry, healthcare, patients, and academia in preparation for its support of the regulation. EMA’s support of the HTAR will include helping to conduct timely joint clinical assessments (JCA) by the HTA Coordination Group (HTACG) by providing relevant information from its own regulatory assessments. The agency will also collaborate with the HTA Coordination Group in joint scientific consultations to provide scientific advice to technology developers and generate evidence to satisfy regulators and HTA bodies. EMA will also exchange information on upcoming applications and technologies for planning purposes.

"EMA welcomes the new HTA regulation and is ready to do what it takes to support the European Commission and the Member States in its successful implementation,” said EMA’s Executive Director, Emer Cooke, in the press release. “While our role is supportive, the new regulation will enable our collaboration across decision-makers reinforcing efforts to improve access to medicines for all patients in the EU. In our network strategy to 2028, facilitating the path to accessibility of new medicines for patients is a priority and the framework for cooperation and the exchange of information between regulators and HTA bodies provided by the new rules will help galvanize our efforts."

EMA has a legal obligation to notify the EC, which is the secretariat to the HTACG, and ensure that procedures are being followed and work is done is a timely and transparent way when marketing authorization applications are received that fall into the scope of JCA. HTACG estimates in 2025 it will need to conduct 17 JCAs for cancer drugs and eight JCAs for ATMPs. EMA also must provide information from ongoing regulatory assessments, details of which will be developed by EMA’s committee for human medicines and the JCA subgroup.

The first request period for JSC will be launched by the HTACG in February 2025, and developers can request parallel JSC with EMA.

“The future processes for parallel JSC have been built based on experience gathered since the initial piloting in 2008 and the iterations of process improvement performed over time. This year, the HTACG is planning to initiate five to seven joint scientific consultations for medicinal products and one to three joint scientific consultations for medical devices,” EMA stated in the press release.

References

1. EMA. New EU Rules for Health Technology Assessments Become Effective. Press Release. Jan. 10, 2025. https://www.ema.europa.eu/en/news/new-eu-rules-health-technology-assessments-become-effective
2. EU. Regulation (EU) 2021/2282 of the European Parliament and of the Council of 15 December 2021 on health technology assessment and amending Directive 2011/24/EU (Text with EEA relevance), Dec. 15, 2021. EUR-Lex. https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32021R2282 (accessed Jan. 10, 2025).