EMA finalizes guidance on parallel MAA, EU-M4all procedure

Regulatory NewsRegulatory News | 22 April 2021 |  By 

The European Medicines Agency (EMA) on Thursday released the final version of its guidance detailing the agency’s procedure for parallel EU-M4all (Article 58) and centralized marketing authorization applications (MAAs).
The guidance was adopted earlier this month following a public consultation launched in January and includes some minor changes from the draft version. (RELATED: EMA offers parallel Article 58, centralized authorization reviews, Regulatory Focus 14 January 2021).
The EU-M4all procedure allows EMA’s Committee for Medicinal Products for Human Use (CHMP) to issue opinions on cooperation with the World Health Organization (WHO) on medicines intended for use in low- and middle-income countries outside the EU to address public health priorities.
So far, the pathway has been used to obtain opinions for 11 products, five of which have been withdrawn for commercial reasons or due to changes in treatment guidelines. EMA says the opinions have led to 138 approvals in 90 non-EU countries as of July 2020.
While the EU-M4all procedure is intended for products that will be used outside the EU, nearly half of the medicines that have undergone the procedure have been centrally authorized in the EU either before or after receiving an EU-M4all opinion.
Most of the three-page guidance is the same as in the draft version released for public consultation, though there have been some minor changes made for clarification.
The guidance now notes that WHO experts and experts/observers from target countries will act as scientific expert reviewers to the EU rapporteurs’ assessment reports (ARs) and provide expertise and input as they would for the standalone EU-M4all procedure.
While some differences between the products undergoing the parallel procedure may be tolerated, such as differences in formulation, pharmaceutical form, storage conditions or routes of administration, EMA now says those differences “should be discussed with the Agency before the submission to determine whether they are compatible with a parallel assessment.”
EMA also clarifies that interested applicants should confirm eligibility for both procedures at the same time. The agency’s recommendation for the specific timing of the eligibility request is the same as in the draft version, at the earliest 18 months prior to submission and at the latest seven months before the joint MAA/EU-M4all application is submitted.
While EMA still advises applicants to present their proposal and dossier during a pre-submission meeting at least six to seven months prior to submission, the agency now encourages applicants to seek early scientific advice as well.
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