New guidelines from the UK Medicines and Health Products Regulatory Agency (MHRA) advise sponsors of ongoing non-COVID-19 trials to conduct risk assessments on the impact of public vaccination efforts on their efforts and indicate to the sponsors of new studies to take vaccination into account in the protocol to avoid substantial amendments later.
If the sponsor considers the COVID-19 vaccine to be “a mere concomitant drug with no interaction that requires advice on timing of vaccine or other aspects,” they may notify the MHRA in the next substantial amendment.
Sponsors who find problems, for example because their experimental products have immune mechanisms, must file substantial modifications. When potential vaccine-study drug interactions are identified, protocols “should include consideration for the specific safety profile of the vaccine and whether a minimum period between any trial IMP dose and dosing with a deployed vaccine must be in place, âsays the MHRA.
If subjects are vaccinated, the MHRA wants sponsors to think about how they will handle causation in safety reports. The Yellow Card scheme applies to adverse events linked to authorized vaccines. Pharmacovigilance rules apply if a side effect is considered to result from an interaction between the vaccine and the investigational product.
Another set of considerations apply to blind trials. The MHRA wants sponsors to consider whether it will be necessary to blind subjects before they receive a COVID-19 vaccine. Sponsors can blind subjects on an individual basis but should encourage them to stay in the study. Subjects should be provided with documents telling them to contact the sponsor when asked to be vaccinated.
The MHRA is working on separate guidelines for COVID-19 vaccine trials.
Swissmedic commits to the FDA’s Orbis project
The Swiss Institute for Therapeutic Products (Swissmedic) has been permanently engaged in the Orbis project, the FDA’s oncology drug application initiative and has issued guidance following its pilot phase of the initiative.
Project Orbis allows drug developers to simultaneously submit applications to multiple regulatory agencies, which then work with the FDA and review cases in parallel. Swissmedic participated in the initiative on a pilot basis last year, during which it licensed the Seagen Tukysa. The Swiss regulator approved Tukysa a month after its US counterpart.
The new guidelines, which come into effect on March 1, outline the requirements for having a drug reviewed under Project Orbis and the process for applicants accepted into the program.
The FDA will contact Swissmedic to find out if it is interested and available to work on a particular file. Swissmedic will accept all type A requests, which, according to it, âallow maximum collaboration during the examination phase and the possibility of simultaneous action with the FDAâ. Type A filings are submitted within 30 days of the initial FDA request. If the available resources or the submission schedule do not allow a simultaneous evaluation with the FDA, Swissmedic can change the type of request.
MHRA asks questions about OTC sales of oral contraceptives
The MHRA is seeking feedback on plans to make the oral contraceptive pill, desogestrel, available without a prescription from pharmacies. The regulator wants to know if the public supports the action and what they think of the pharmacy consultation checklist prepared to support the reclassification.
Today, Laboratoire HRA Pharma and Maxwellia market 75 microgram film-coated tablets of desogestrel under the brands Hana and Lovima, respectively. Women who wish to use the tablets must obtain a prescription from their doctor. The proposed reclassification would allow women to purchase the tablets from over-the-counter (OTC) pharmacists.
The Commission for Medicinal Products for Human Use has ruled that Hana and Lovima meet the criteria to be sold by pharmacists without a prescription. However, the MHRA wishes to assess public opinion on the proposal before authorizing OTC sales of the oral contraceptive.
In a pair of consultation papers covering Hana and Lovima, the MHRA set out the criteria that products must meet to be cleared for sale in pharmacies and the relevant evidence on both drugs. The criteria cover the hazards posed by the products and the uncertainties about their effects.
Pamphlets, labels and pharmacy consultation checklists are already available for Hana and Lovima. The MHRA wants to know what the public thinks about the equipment and its plans to make drugs available without a prescription. The agency is accepting comments until March 5.
MHRA Opinion, Lovima Consultation, Hana Consultation
DKMA hires to strengthen COVID vaccine safety oversight
The Danish Medicines Agency (DKMA) is recruiting to create a pharmacovigilance team of 15-20 people focused on COVID-19 vaccines. The agency is putting in place the new team to ensure it has the capacity to quickly process and analyze reports of suspected vaccine adverse reactions.
Mass vaccination campaigns with newly approved products create the potential for huge volumes of adverse event reports that could exceed the ability of regulators to detect safety signals. Tanja Erichsen, director of pharmacovigilance at DKMA, said her team was “in the midst of the biggest surveillance efforts in history” and was acting to make sure it can cope.
DKMA is recruiting up to 20 employees to be part of a COVID-19 vaccine team that will record and validate reports of adverse events. New recruits will need to be trained in a medical field. Experience with drug safety is not a prerequisite.
The positions will be limited in time and will start on March 15th. This start date means that the team will be in place before the acceleration of the Danish vaccination campaign. Danish authorities plan to give more than 700,000 doses in March, up from around 400,000 this month. The dosage will rise again in April, when authorities plan to administer more than 2 million doses.
DKMA Notice, Job Offer (Danish)
The European Commission has appointed the Italian Istituto Superiore di SanitÃ (ISS) as the notified body for the new medical device regulation (MDR). The ISS is the 19th notified body designated under the MDR and the second Italian body to receive the status. The designation comes amid persistent concerns about the capacity availability of MDR notified bodies. SSI designation
Paula Loekemeijer is expected to succeed Hugo Hurts as executive director of the Dutch Medicines Evaluation Board (MEB). Hurts will retire in early September. Loekemeijer returns to the MEB after a period in the Dutch general intelligence and security service. MEB Notice (Dutch)
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