Euro Roundup: MHRA advises on non-COVID trials amid vaccine rollout

| 18 February 2021 | By Nick Paul Taylor 

New guidance from the UK Medicines and Healthcare products Regulatory Agency (MHRA) advises sponsors of ongoing non-COVID-19 trials to conduct risk assessments for how public vaccination efforts will impact their efforts and tells sponsors of new studies to factor vaccination into the protocol to avoid substantial amendments later.
If the sponsor deems the COVID-19 vaccine to be “a simple concomitant medication with no interaction that requires advice on timing of the vaccine or other aspects,” it can inform MHRA in the next substantial amendment.
Sponsors that find issues, for example because their investigational products have immune-related mechanisms, need to file substantial amendments. When potential interactions between the vaccine and study drug are identified, the protocols “must include consideration for the specific safety profile of the vaccine and whether a minimum time period between any dose of trial IMP and dosing with a deployed vaccine must be in place,” MHRA said.
If subjects are vaccinated, MHRA wants sponsors to consider how they will handle causality in safety reporting. The Yellow Card scheme applies to adverse events linked to the authorized vaccines. The pharmacovigilance rules apply if a side effect is considered to stem from an interaction between the vaccine and investigational product.
A further set of considerations apply to blinded trials. MHRA wants sponsors to consider whether it will be necessary to unblind subjects before they receive a COVID-19 vaccine. Sponsors can unblind subjects on an individual basis but should encourage them to remain in the study. Subjects should be given materials telling them to contact the sponsor when they are invited to get a vaccine.
MHRA is working on separate guidance for COVID-19 vaccine trials.
MHRA Guidance
Swissmedic commits to FDA’s Project Orbis
The Swiss Agency for Therapeutic Products (Swissmedic) has committed permanently to Project Orbis,  the FDA oncology drug application initiative and issued guidance following its pilot phase of the initiative.
Project Orbis enables drug developers to simultaneously submit applications to multiple regulatory agencies, which then work with FDA and in parallel to examine the filings. Swissmedic participated in the initiative on a pilot basis last year, during which time it authorized Seagen’s Tukysa. The Swiss regulator approved Tukysa one month after its counterpart in the US.
The new guidance, which will take effect 1 March, describes the requirements for having a drug reviewed under Project Orbis and the process for applicants accepted into the program.
FDA will contact Swissmedic to learn if it is interested and available to work on a particular filing. Swissmedic will accept all Type A applications, which it says “allow for maximal collaboration during the review phase and the possibility of concurrent action with FDA.” Type A filings are submitted within 30 days of the original application to FDA. If the available resources or submission timing do not allow concurrent assessment with FDA, Swissmedic may change the application type.
Swissmedic Notice
MHRA asks about OTC sales of oral contraceptive
MHRA is seeking feedback on plans to make the oral contraceptive pill desogestrel available without a prescription from pharmacies. The regulator wants to know whether the public supports the action and what they think about the pharmacy consultation checklist prepared to support reclassification.
Today, Laboratoire HRA Pharma and Maxwellia sell 75 microgram film-coated tablets of desogestrel under, respectively, the brand names Hana and Lovima. Women who want to use the tablets need to get a prescription from their doctor. The proposed reclassification would enable women to buy the tablets from pharmacists over the counter (OTC).
The Commission on Human Medicines has ruled Hana and Lovima meet the criteria for being sold by pharmacists without a prescription. However, MHRA wants to gauge public opinion on the proposal before permitting OTC sales of the oral contraceptive.
In a pair of consultation documents covering Hana and Lovima, MHRA set out the criteria products need to meet to be cleared for sale in pharmacies and relevant evidence on the two medicines. The criteria cover the dangers posed by the products and uncertainties about their effects.
Proposed leaflets, labels and pharmacy consultation checklists are already available for Hana and Lovima. MHRA wants to know what the public thinks of the materials and its plans to make the drugs available without a prescription. The agency is accepting feedback until 5 March.
MHRA Notice, Lovima Consultation, Hana Consultation
DKMA hiring to beef up COVID vaccine safety monitoring
The Danish Medicines Agency (DKMA) is hiring to create a 15-to-20-person pharmacovigilance team focused on COVID-19 vaccines. The agency is building the new team to ensure it has the capacity to quickly process and analyze reports of suspected adverse reactions to the vaccines.
Mass-vaccination campaigns with newly approved products create the potential for huge volumes of adverse event reports that could overwhelm the ability of regulatory agencies to spot safety signals. Tanja Erichsen, DKMA’s director of pharmacovigilance, said their team is “in the middle of the biggest monitoring efforts in history” and is acting to ensure it can cope.
DKMA is recruiting up to 20 staff to serve on a COVID-19 vaccine team that will register and validate adverse event reports. The new hires will need to be educated in a medical field. Experience of drug safety is not a prerequisite.
The positions will be time limited and begin on 15 March. That start date means the team will be in place ahead of the ramping up of the Danish vaccination campaign. Danish authorities expect to give more than 700,000 doses in March, up from around 400,000 this month. Dosing will jump again in April, when authorities expect to administer more than 2 million doses.
DKMA Notice, Job Listing (Danish)
Other News:
The European Commission has designated Italy’s Istituto Superiore di Sanità (ISS) as a notified body for the incoming Medical Devices Regulation (MDR). ISS is the 19th notified body designated under MDR and the second organization from Italy to receive the status. The designation comes amid continued concerns about the availability of MDR notified body capacity. ISS Designation
Paula Loekemeijer is set to succeed Hugo Hurts as executive director of the Dutch Medicines Evaluation Board (MEB). Hurts will retire at the start of September. Loekemeijer is returning to MEB after a period at the Dutch General Intelligence and Security Service. MEB Notice (Dutch)


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