Out-Law News 2 min. read

Agreement reached on new rules on clinical trials

MEPs and EU Ministers have reached a provisional agreement on new EU rules on clinical drugs trials.

The agreement, formed between Lithuanian Presidency of the Council of Ministers and the European Parliament late last month, will see a new Clinical Trials Regulation introduced once formally adopted.

Under the new framework, businesses wishing to conduct clinical drugs trials will be required to apply to do so via a new electronic portal.

Researchers wishing to conduct trials across the EU will only have to submit a single application through the portal for joint assessment by member states. National ethics committees will continue to scrutinise applications separately, but a joint decision about whether to approve trials in their jurisdiction would have to be made by the member states and the ethics committees following consultation with one another.

Currently in the UK, authorisation to proceed with trials in the UK is required from the Medicines and Healthcare products Regulations Agency (MHRA), whilst an ethics committee must also approve proposed studies. Researchers also require approvals from each different NHS body that is involved.

The MHRA welcomed the new procedure for assessing applications made under the new Regulation.

"Member States will jointly assess clinical trials that will take place in multiple countries," the regulator said in a statement. "This excludes the ethical aspects of the trial which will continue to be examined by national ethics committees. The sponsor can choose the reporting member state who will coordinate the assessment of the application. All concerned member states must then adopt the conclusion of the reporting member state unless they opt out and the reasons to opt out are defined in the legislation."

"At member state level there will be one decision replacing the currently separate approvals by regulator and ethics committee. This will require closer collaboration between regulators and ethics committees," it said.

Rules on the patient privacy and consent have been "strengthened and harmonised" as a result of the new rules, the MHRA said. It also said that there would be greater transparency of the results of clinical trials under the new regime.

"All clinical trials in the EU will need to be registered and for all clinical trials, a summary of results will need to be published within one year after the trial has ended," the regulator said. "When a clinical study report has been submitted in support of a marketing authorisation, this report will also have to be made available by the applicant within 30 days after a regulatory decision on the application." 

EU Health Commissioner Tonio Borg said: "Clinical trials are indispensable for developing and improving medicines and ensuring that EU patients can have access to the most innovative and effective treatments, under high safety and ethical standards. The revised rules will ensure that the EU remains an attractive location for clinical research – which is of vital importance for Europe's competitiveness and innovation capacity."

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