The United Kingdom is set to join Australia, Canada, Singapore and Switzerland in a regulatory consortium when it splits from the European Union at the start of next year, enabling companies to access all five markets using a single application.
Since before the 2016 Brexit vote, drug developers have warned that leaving the EU could delay access to new medicine for UK patients. The Medicines and Healthcare products Regulatory Agency (MHRA) has responded to the concerns by joining the Australia-Canada-Singapore-Switzerland Consortium. When MHRA joins in January, the rebranded Access Consortium will cover countries that are home to 145 million people.
The original members set up the consortium, then known as ACSS, in 2007 to promote convergence, reduce the duplication of efforts and accelerate access to new medicines. In recent years, ACSS has delivered on those goals by coordinating the review of applications for approval of four new drugs, namely Erlyand, Verzenio, Zejula and Xofluza. ACSS members took the lead on assessing different parts of the applications and then independently decided to approve the medicines in their markets.
MHRA will become a full Access member able to take part in such cooperative assessments and other activities at the start of January. The agency is set to join the US Food and Drug Administration’s Project Orbis the same day.
Joining the initiatives positions MHRA to share the burden of reviewing submissions, as it previously did with other EU regulators, and accelerate UK access to some medicines. However, the initiatives currently cover relatively few medicines, with ACSS handling three new drugs since its first approval in mid-2018 and Project Orbis limited to cancer and only authorizing its first product this year.
MHRA’s involvement could increase use of the initiatives, particularly in the case of ACSS. The UK population is almost as large as that of the four ACSS members combined, meaning the involvement of MHRA will significantly increase the market accessible via the consortium.
Denmark extends COVID extraordinary measures through 2021
The Danish Medicines Agency (DKMA) has extended the extraordinary measures established to help clinical trial sponsors cope with COVID-19 through December 2021, while encouraging sponsors to re-establish normal processes when possible.
When DKMA first proposed the temporary measures in March, it planned to allow sponsors to take advantage of the revised, more flexible rules and processes until mid-June; continuing disruption led DKMA to repeatedly extend the flexibility.
Elsewhere, DKMA told sponsors that changes to clinical trials they wish to retain “after stabilization of the COVID-19 pandemic” must be submitted for approval as amendments. DKMA also used the update to clarify that its decision to allow remote source data verification is a temporary measure to help companies through the pandemic and requires a substantial amendment to be sent for approval before implementation.
Other changes include a clarification to DKMA’s position on the shipment of investigational medicinal products directly to trial subjects from investigator sites. DKMA, which granted sponsors that option in an earlier update, said direct packaging and shipping “must be carried out under double control,” adding that sponsors should consider whether it is necessary to phone the trial participant after they receive an investigational medicinal product to provide another layer of control.
EMA seeks feedback on revised immunoglobulin clinical trial guideline
EMA has released draft guidelines on the clinical development of human normal immunoglobulin for intravenous administration for consultation. EMA is using the update to add a section on measles post-exposure prophylaxis.
Immunoglobulin is administered as post-exposure prophylaxis when babies, individuals with severely compromised immune systems and others at risk of severe illness and complications from measles are exposed to the virus. The draft guideline explains how immunoglobulin developers can position their products for use in that context.
If a developer adds a certain anti-measles antibody titer threshold to the product specification, it can include the indication “measles post-exposure prophylaxis” as specified in the core Summary of Product Characteristics in the product information.
The other notable change is the deletion of a section on studies in elderly patients. The deleted section said studies in the elderly are not necessary but sponsors are encouraged to include elderly patients in their clinical trials.
EMA is accepting feedback on the draft guideline until 13 January.
France establishes new rules on stool donation
The French National Agency for Medicines and Health Products Safety (ANSM) has established rules to prevent the transmission of SARS-CoV-2 via fecal microbiota transplants (FMT).
ANSM put a stop to stool collections early in the pandemic after the coronavirus was found in feces. In August, ANSM cleared healthcare professionals to resume the collection of stools but asked them to quarantine materials until it validated additional protection methods. ANSM
further details at the start of October and followed up last week with another update.
The latest ANSM update establishes new rules for healthcare professionals to follow when collecting stool samples. ANSM wants healthcare professionals to assess the SARS-CoV-2 risk of potential stool donors. People who may have been infected with the virus are banned from donating for 28 days. Healthcare professionals also need to test nasopharyngeal samples and donor stools for SARS-CoV-2.
ANSM is advising people treated with FMT to contact their doctor if they experience a fever and breathing difficulties.
IFPMA, EFPIA voice support for EMA’s COVID transparency measures
IFPMA and EFPIA have voiced support for transparency measures EMA is implementing in relation to COVID-19. The trade groups want “other national regulatory authorities to follow EMA’s example.”
Last week, EMA committed to publish clinical data underpinning recommendations about COVID-19 medicines and discussed the reinstatement of its policy on proactive publication of clinical data for coronavirus products. In welcoming the actions, IFPMA and EFPIA highlighted measures such as the acceleration of the publication of news about rolling reviews and other key documents.
“The EMA initiative of exceptional transparency measures will help to enhance trust and confidence in the evaluation and approval process that is critical during COVID-19,” EFPIA director general Nathalie Moll said.
IFPMA and EFPIA are encouraging other national regulators to take similar actions to EMA.