EMA: Pilot bringing ex-EU regulators to COVID product meetings was a success

Regulatory NewsRegulatory News | 12 July 2022 |  By 

Involving non-EU regulatory authorities in the assessment of COVID-19 vaccines and therapies helped regulators accelerate and align on decisions, according to a new report from the European Medicines Agency (EMA).
EMA made the comments in a review of the OPEN (Opening our Procedures at EMA to Non-EU authorities) initiative also reporting that it “had enhanced communication channels and facilitated discussions and exchanges.”
The OPEN programme – which debuted in 2020 – invited regulators from Canada, Japan, Switzerland and Australia to attend and contribute to ETF and CHMP evaluations of COVID-19 vaccines and therapeutics. World Health Organisation (WHO) scientists also took part. (RELATED: EMA pilot brings outside regulators into committee work, Regulatory Focus 4 February 2021)
While all parties retained full scientific and regulatory independence, the idea was to facilitate sharing of scientific expertise, tackle common challenges, enhance transparency on decisions and support the assessment of vaccines and therapeutics for COVID-19.
And, according to the EMA reviewers, the pilot phase of the programme was a success.
“Collaboration among international regulators was key in the context of COVID-19 and the OPEN pilot facilitated the assessment of the same data by multiple authorities. The pilot enhanced communication channels and facilitated discussions and exchanges.
“In addition, OPEN allowed regulators to accelerate and align on decisions, leading to fewer labelling differences, while maintaining independence in the decision making.”
WHO benefits
The benefits of the OPEN collaboration extended beyond the parties that took part, according to EMA.
“The partnership with WHO also meant that the OPEN pilot contributed to global health by breaking down regulatory barriers and facilitating access and equity for COVID-19 vaccines and therapeutics,” the report stated. “The WHO Prequalification team, leveraging its participation in OPEN, uses the EMA assessments for the WHO Emergency Use Listing (EUL) of the vaccines and therapeutics authorised in the EU. WHO then encourages the recognition of the WHO EUL and Prequalification list for national authorisation of or other regulatory action for the COVID-19 vaccines or therapeutics.”
“These reliance mechanisms are crucial tools to make best use of regulatory capacities in resource-limited settings, avoid duplication where possible and reduce the time to access to medicines for patients,” the EMA reviewers added.
Fine tuning
The EMA also asked scientists who took part in OPEN to share their thoughts on the programme and, again, the findings were positive.
“The survey confirmed that the OPEN Pilot facilitated the assessment of the same data by multiple authorities and all respondents agreed that the initiative should continue after the pilot. In addition, EU experts would find beneficial to increase collaboration and contributions from participating OPEN experts within each procedure, while maintaining full scientific and regulatory independence.”
The survey also highlighted some areas in which the programme could be improved. More detailed rules of engagement, for example, would promote “reciprocity of information exchange and more active participation” according to the survey.
The EMA reviewers wrote “ETF and CHMP members found most useful to receive from OPEN regulators: assessment reports, comments on the EU scientific evaluation, divergent analysis, advanced planned regulatory actions or advanced public communications.
“However, we could also envisage different types of engagement at the start of the evaluation by giving the choice to OPEN regulators to actively contribute or to only receive the EU assessment and therefore setting clear expectations.”
The reviewers also suggested the OPEN approach could be applied to other “high impact” areas such as vaccines or medicines needed during other public health emergencies and antimicrobial resistance (AMR).
 In addition, the model could even be used for the collaborative assessment of CMC aspects of innovative manufacturing methods deemed to have the potential to increase availability of key medicines.
The next steps of the project will see the EMA engage with CHMP and its other committees to define the terms of reference and strengthen the value-added exchanges where a greater focus should be put to facilitate submission, review and approval of the specific medicines.
The EMA also said it will organize review meetings with OPEN regulators to better define the framework, increase the efficiency of the interactions and align future goals and objectives.


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