Euro Roundup: EMA streamlines processes to handle COVID-19 volume

The European Medicines Agency (EMA) is temporarily revising its processes to cope with a rising volume of work related to the COVID-19 pandemic. EMA made the changes to ensure it can handle a “very active pipeline” that is expected to yield up to five COVID-19 therapies this year.
 
Faced with that workload, EMA is temporarily freeing co-rapporteurs from the need to provide their own assessment reports on initial marketing authorization applications for non-COVID-19 products. Instead, co-rapporteurs will review data and “give a detailed critique of the rapporteur’s assessment report,” freeing up time for COVID-19 work. Co-rapporteurs will still provide their own reports on advanced therapies and other complex medicines.
 
EMA is also temporarily dropping its practice of having a separate, formally appointed peer reviewer. Rather, EMA will “rely on the intrinsic peer review” in the evaluation process of the Committee for Medicinal Products for Human Use (CHMP). The temporary measure will apply to all applications.
 
The agency is making similar changes to its processes for post-authorization line extensions. Under the temporary measures, co-rapporteurs will no longer draft a full separate report in the first evaluation phase of non-COVID-19 products. Their involvement will be limited to comments on the rapporteur’s report.
 
For COVID-19 products, co-rapporteurs “will be systematically involved” but, “The need for two separate assessment reports, or for providing a detailed critique of the rapporteur’s assessment report, will depend on the complexity of the application.”
 
All the changes took effect this month.
 
EMA Notice
 

MHRA finalizes biosimilar licensing guidance, building on older EMA text

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has finalized its guidance on the licensing of biosimilar products. MHRA based the document on the existing CHMP guidance but sought to incorporate experience gained since those texts were written.
 
When MHRA held a consultation on the draft guidance last year, it highlighted additional details about UK reference products, the lack of requirement for in vivo studies in animals and the changes in the requirement for a comparative efficacy trial in most cases as the main differences between the document and its foundational EMA texts.
 
This week, MHRA shared details of the feedback it received, revealing that “a few respondents questioned the basis for not requiring confirmatory clinical efficacy and in vivo animal studies.” MHRA maintained its position in the face of the feedback and shared studies that support its stance.
 
MHRA’s summary of the feedback reveals a tension over the future direction of the agency. Some respondents called for “MHRA to go further and take a lead in global regulation of biosimilars,” the agency said, while others called out areas in which the text appeared to diverge from CHMP. Some of the points about divergence reflected a misunderstanding that MHRA has cleared up in the final text.
 
Other changes include the addition of information about the sourcing of reference products now that the UK is no longer part of the EU and the inclusion of a discussion of factors that are important to patients, such as injection pain. MHRA included the patient-focused points in response to feedback from advocacy groups.  
 
Final Guidance, Consultation Response
 

EMA, Brazil agree to share confidential information on medical products

Regulatory authorities in Brazil and the European Union have entered into an arrangement that will enable the sharing of confidential information related to inspections, pharmacovigilance and other topics.
 
The arrangement covers EMA, the European Commission’s health group DG SANTE and the Brazilian Health Regulatory Agency (Anvisa). Under the terms of the agreement, the three parties will share sensitive information about medical and medicinal products, including details of good clinical and manufacturing practice inspections and applications for marketing authorization.
 
Confidentiality arrangements form part of EMA’s efforts to support effective international responses to fast-emerging issues. By clearing barriers to the exchange of sensitive information, EMA thinks it can respond more effectively to drug shortages, quality concerns and safety questions.
 
EMA said the Anvisa confidentiality agreement, which is already in effect, will remain valid indefinitely. The partners may choose to build on the existing arrangement, though, with EMA describing it as a “step towards mutual recognition and regulatory harmonization.”
 
The European Union currently has mutual recognition agreements with seven countries. Most of the countries and organizations with standing confidentiality arrangements with EMA also have mutual recognition agreements with the agency. Brazil, the European Directorate for the Quality of Medicines and the World Health Organization are the exceptions.
 
EMA Notice, Working Arrangement
 

MHRA approves first drug under FDA oncology initiative Project Orbis

MHRA has approved a drug under the international oncology product review initiative Project Orbis for the first time. The drug, AstraZeneca’s Tagrisso, won approval in the UK after undergoing a review that involved the US Food and Drug Administration (FDA) and agencies in five other countries.
 
Project Orbis enables companies to make concurrent filings for cancer drugs in multiple markets. The UK joined the initiative at the start of the year as part of its preparations for life outside the EU, by which time FDA had already approved Tagrisso for adjuvant treatment of adults with early-stage epidermal growth factor receptor-mutated non-small cell lung cancer after tumor resection.
 
MHRA leveraged the work of FDA and other Project Orbis members to approve Tagrisso in the same population. The action means Tagrisso will come to market earlier in the UK than in the EU, offering ammunition for politicians keen to promote the perceived benefits of Brexit.
 
“Leaving the EU presented us with the opportunity to join Project Orbis — an international collaboration with the top regulators around the world — to speed up the time it takes to get these new medicines to patients,” Matt Hancock, the UK health and social care secretary, said.
 
CHMP recommended the approval of Tagrisso in the indication last month. AstraZeneca is now waiting for the European Commission to grant the recommended change to the marketing authorization.   
 
MHRA Notice
 

Commission starts public consultation on orphan and pediatric medicines 

The European Commission is seeking feedback on EU rules covering medicines for children and rare diseases. Officials want to address perceived shortcomings of the current rules such as the failure to drive development in the areas of greatest unmet need and unequal access to medicines.
 
To tackle those problems, the Commission has created a survey that asks stakeholders to provide views on certain rare disease approaches, including whether cancers that affect small numbers of patients should still be treated as orphan drugs. The survey also asks people to grade the effectiveness of measures such as more EMA support, priority review and incentives.
 
The Commission has also posed several open-ended questions, for example by asking for views on how COVID-19 has affected the problems of pediatric and orphan medicine development. Officials want to know if there are lessons from the pandemic that could apply to medicines for rare diseases and children.
 
Commission Notice
 

Other News:

 The European Commission has published a delegated regulation intended to accelerate access to vaccines against COVID-19 variants in the Official Journal of the European Union. The text was agreed upon and shared in March. Journal Entry, Regulatory Focus
 
The Finnish Medicines Agency (Fimea) has expanded its Clinical Trial Regulation pilot project to include applications about changes to existing studies. Fimea Notice (Finnish)